Liz Scherer

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In recent years, increased use of integrase strand transferase inhibitor (INSTI) antiviral treatment (ART) has raised concerns about weight gain and adverse outcomes in patients with HIV. This is especially true regarding possible excessive gestational weight gain, which in women without HIV has been associated with maternal gestational diabetes, hypertensive and liver conditions, as well as related risks for preterm birth, fetal macrosomia, and higher weight after birth. 

Unfortunately, few studies in pregnant women with HIV have moved out of the controlled environment into real-world settings, potentially limiting current knowledge about the impact of gestational weight gain – as well as strategies to both prevent it and the associated adverse outcomes.

That is what a team of infectious disease specialists at the Hospital Federal dos Servidores do Estado in Rio de Janeiro recently sought to answer among a cohort of INSTI-experienced and INSTI-naive women with BMIs less than 25 kg/m² (underweight/normal weight) and higher than 25 kg/m².
 

Surprising findings

The investigators determined that rates of excessive weight gain were significantly higher in INSTI-naive women with BMI less than 25 who experienced rates as high as 31.6%, compared with approximately 12% of women who conceived while on INSTIs, regardless of BMI values at baseline (P = .004). 

However, rates of unfavorable pregnancy outcomes (for example, small for gestational age, preterm birth, stillbirth, death) appeared to be low overall and similar among all the study groups.

“We had some discussions when we were working on this and thought that the weight gain might have adverse effects,” Trevon Fuller, PhD, lead author and a postdoctoral student at the Hospital Federal dos Servidores do Estado, told this news organization.

“But it looked like the weight gain might actually be good, to the extent that we didn’t see any harm to the mom or the baby of those underweight or normal weight women who were naive to INSTIs,” he explained.

Dr. Fuller and his team enrolled 198 pregnant women living with HIV who sought care at the Hospital Federal dos Servidores do Estado – a national reference center for USAID’s Prevention of Mother to Child Transmission strategic program – between October 2014 and October 2021.

Participants were divided into two primary cohorts: BMI less than 25 at enrollment (n = 74) or BMI of 25 or higher (n = 124), then further divided by timing of INSTI-based combined ART: 

• INSTI-naive: women using INSTI-based ART (raltegravir [Isentress] 400 mg twice per day or dolutegravir [Tivicay] 50 mg/day plus 2 non-nucleoside reverse transcriptase inhibitors – lamivudine plus tenofovir disoproxil fumarate or lamivudine plus zidovudine) for 4 weeks between baseline and near delivery.
• INSTI-experienced: women who became pregnant while using INSTIs for at least 6 months before conception. 

Among underweight/normal weight participants, 77% (n = 57) were INSTI-naive and 23% (n = 17) INSTI-experienced, and among overweight/obese participants, 81.5% (n = 101) were INSTI-naive, and 18.5% (n = 23) were experienced.

Maternal age, which did not differ significantly by BMI or treatment experience, was a median of 28 years, and most participants were non-White. All participants were virally suppressed near delivery.

Study findings, which were published online  in HIV Medicine, highlighted that median weight near delivery in participants who were overweight/obese at baseline was similar regardless of whether they were treatment-experienced (90 kg [198 lb]) or treatment-naive (82.3 kg [181 lb]), P = .026.

However, participants who were underweight/normal weight who were INSTI-naive had significantly higher rates of gestational weight gain (31.5%, 18/57), compared with those of underweight/normal weight who were INSTI-experienced (11.8%, 2/17), P = .004. Notably, this gain was significant in all categories of change (that is, low < 0.18 kg/week, normal 0.18-0.59 kg/week), and high > 0.59 kg/week).

“One of the things that we took away was that this weight gain is primarily happening with women who are starting INSTIs,” said Dr. Fuller. 

“The data suggest that [it] might be temporary in the sense that there’s not going to be continuous weight gain but that it will probably approach some type of horizontal asymptote,” he added.

Although obstetric and neonatal outcomes were secondary measures, the investigators did not observe any significantly different outcomes when comparing the groups, and there were no stillbirths, neonatal deaths, or macrosomia.

Preterm delivery rates in underweight/normal weight participants who were INSTI-experienced (11.8%, 2/17) and INSTI-naive (5.3%, 3/57) were similar to overweight/obese participants who were INSTI-experienced (13%, 3/23) and INSTI-naive (6.9%, 7/101).

The same was true for low birthweight.

Still, the study appears to raise more questions than it answers, Sigal Yawetz, MD, an infectious disease specialist at Brigham and Women’s Hospital, Boston, said in an interview – a factor that she said is common also in some of the more recent randomized controlled studies, such as IMPAACT PROMISE.

Dr. Yawetz, who was not involved in the study, also noted, “The groups were small, so comparisons within the groups are difficult, and so many people were excluded that it’s hard to know if there were adverse outcomes related to this ... It’s very confounded.”

The World Health Organization estimates that there are roughly 1.3 million pregnant women with HIV, 81% of whom are on antiretroviral therapy. Although the literature continues to evolve, data suggest that in general, Black women are at greater risk for gestational weight gain.

“We have to remember that women who gain excess weight in pregnancy are still going to be with this weight following pregnancy as well,” Dr. Yawetz said. “So, it might impact their pregnancy but also their health after delivery and for subsequent pregnancies, which we don’t have data for yet.”

Dr. Fuller agrees that more data are needed and mentioned that the team plans to study this further, ideally with larger sample sizes.

Yet, despite the lingering questions, there is a silver lining, one that Dr. Yawetz was emphatic about.

“I really welcome people doing studies on this because we really need the data. By far, integrase inhibitors are the first-line regimen all over the world for pregnant women, and if you look at the gestalt or full picture, this is the best regimen to give pregnant women,” she said.

Dr. Fuller and Dr. Yawetz report no relevant financial relationships. The study was independently supported.

A version of this article first appeared on Medscape.com.

In recent years, increased use of integrase strand transferase inhibitor (INSTI) antiviral treatment (ART) has raised concerns about weight gain and adverse outcomes in patients with HIV. This is especially true regarding possible excessive gestational weight gain, which in women without HIV has been associated with maternal gestational diabetes, hypertensive and liver conditions, as well as related risks for preterm birth, fetal macrosomia, and higher weight after birth. 

Unfortunately, few studies in pregnant women with HIV have moved out of the controlled environment into real-world settings, potentially limiting current knowledge about the impact of gestational weight gain – as well as strategies to both prevent it and the associated adverse outcomes.

That is what a team of infectious disease specialists at the Hospital Federal dos Servidores do Estado in Rio de Janeiro recently sought to answer among a cohort of INSTI-experienced and INSTI-naive women with BMIs less than 25 kg/m² (underweight/normal weight) and higher than 25 kg/m².
 

Surprising findings

The investigators determined that rates of excessive weight gain were significantly higher in INSTI-naive women with BMI less than 25 who experienced rates as high as 31.6%, compared with approximately 12% of women who conceived while on INSTIs, regardless of BMI values at baseline (P = .004). 

However, rates of unfavorable pregnancy outcomes (for example, small for gestational age, preterm birth, stillbirth, death) appeared to be low overall and similar among all the study groups.

“We had some discussions when we were working on this and thought that the weight gain might have adverse effects,” Trevon Fuller, PhD, lead author and a postdoctoral student at the Hospital Federal dos Servidores do Estado, told this news organization.

“But it looked like the weight gain might actually be good, to the extent that we didn’t see any harm to the mom or the baby of those underweight or normal weight women who were naive to INSTIs,” he explained.

Dr. Fuller and his team enrolled 198 pregnant women living with HIV who sought care at the Hospital Federal dos Servidores do Estado – a national reference center for USAID’s Prevention of Mother to Child Transmission strategic program – between October 2014 and October 2021.

Participants were divided into two primary cohorts: BMI less than 25 at enrollment (n = 74) or BMI of 25 or higher (n = 124), then further divided by timing of INSTI-based combined ART: 

• INSTI-naive: women using INSTI-based ART (raltegravir [Isentress] 400 mg twice per day or dolutegravir [Tivicay] 50 mg/day plus 2 non-nucleoside reverse transcriptase inhibitors – lamivudine plus tenofovir disoproxil fumarate or lamivudine plus zidovudine) for 4 weeks between baseline and near delivery.
• INSTI-experienced: women who became pregnant while using INSTIs for at least 6 months before conception. 

Among underweight/normal weight participants, 77% (n = 57) were INSTI-naive and 23% (n = 17) INSTI-experienced, and among overweight/obese participants, 81.5% (n = 101) were INSTI-naive, and 18.5% (n = 23) were experienced.

Maternal age, which did not differ significantly by BMI or treatment experience, was a median of 28 years, and most participants were non-White. All participants were virally suppressed near delivery.

Study findings, which were published online  in HIV Medicine, highlighted that median weight near delivery in participants who were overweight/obese at baseline was similar regardless of whether they were treatment-experienced (90 kg [198 lb]) or treatment-naive (82.3 kg [181 lb]), P = .026.

However, participants who were underweight/normal weight who were INSTI-naive had significantly higher rates of gestational weight gain (31.5%, 18/57), compared with those of underweight/normal weight who were INSTI-experienced (11.8%, 2/17), P = .004. Notably, this gain was significant in all categories of change (that is, low < 0.18 kg/week, normal 0.18-0.59 kg/week), and high > 0.59 kg/week).

“One of the things that we took away was that this weight gain is primarily happening with women who are starting INSTIs,” said Dr. Fuller. 

“The data suggest that [it] might be temporary in the sense that there’s not going to be continuous weight gain but that it will probably approach some type of horizontal asymptote,” he added.

Although obstetric and neonatal outcomes were secondary measures, the investigators did not observe any significantly different outcomes when comparing the groups, and there were no stillbirths, neonatal deaths, or macrosomia.

Preterm delivery rates in underweight/normal weight participants who were INSTI-experienced (11.8%, 2/17) and INSTI-naive (5.3%, 3/57) were similar to overweight/obese participants who were INSTI-experienced (13%, 3/23) and INSTI-naive (6.9%, 7/101).

The same was true for low birthweight.

Still, the study appears to raise more questions than it answers, Sigal Yawetz, MD, an infectious disease specialist at Brigham and Women’s Hospital, Boston, said in an interview – a factor that she said is common also in some of the more recent randomized controlled studies, such as IMPAACT PROMISE.

Dr. Yawetz, who was not involved in the study, also noted, “The groups were small, so comparisons within the groups are difficult, and so many people were excluded that it’s hard to know if there were adverse outcomes related to this ... It’s very confounded.”

The World Health Organization estimates that there are roughly 1.3 million pregnant women with HIV, 81% of whom are on antiretroviral therapy. Although the literature continues to evolve, data suggest that in general, Black women are at greater risk for gestational weight gain.

“We have to remember that women who gain excess weight in pregnancy are still going to be with this weight following pregnancy as well,” Dr. Yawetz said. “So, it might impact their pregnancy but also their health after delivery and for subsequent pregnancies, which we don’t have data for yet.”

Dr. Fuller agrees that more data are needed and mentioned that the team plans to study this further, ideally with larger sample sizes.

Yet, despite the lingering questions, there is a silver lining, one that Dr. Yawetz was emphatic about.

“I really welcome people doing studies on this because we really need the data. By far, integrase inhibitors are the first-line regimen all over the world for pregnant women, and if you look at the gestalt or full picture, this is the best regimen to give pregnant women,” she said.

Dr. Fuller and Dr. Yawetz report no relevant financial relationships. The study was independently supported.

A version of this article first appeared on Medscape.com.

In recent years, increased use of integrase strand transferase inhibitor (INSTI) antiviral treatment (ART) has raised concerns about weight gain and adverse outcomes in patients with HIV. This is especially true regarding possible excessive gestational weight gain, which in women without HIV has been associated with maternal gestational diabetes, hypertensive and liver conditions, as well as related risks for preterm birth, fetal macrosomia, and higher weight after birth. 

Unfortunately, few studies in pregnant women with HIV have moved out of the controlled environment into real-world settings, potentially limiting current knowledge about the impact of gestational weight gain – as well as strategies to both prevent it and the associated adverse outcomes.

That is what a team of infectious disease specialists at the Hospital Federal dos Servidores do Estado in Rio de Janeiro recently sought to answer among a cohort of INSTI-experienced and INSTI-naive women with BMIs less than 25 kg/m² (underweight/normal weight) and higher than 25 kg/m².
 

Surprising findings

The investigators determined that rates of excessive weight gain were significantly higher in INSTI-naive women with BMI less than 25 who experienced rates as high as 31.6%, compared with approximately 12% of women who conceived while on INSTIs, regardless of BMI values at baseline (P = .004). 

However, rates of unfavorable pregnancy outcomes (for example, small for gestational age, preterm birth, stillbirth, death) appeared to be low overall and similar among all the study groups.

“We had some discussions when we were working on this and thought that the weight gain might have adverse effects,” Trevon Fuller, PhD, lead author and a postdoctoral student at the Hospital Federal dos Servidores do Estado, told this news organization.

“But it looked like the weight gain might actually be good, to the extent that we didn’t see any harm to the mom or the baby of those underweight or normal weight women who were naive to INSTIs,” he explained.

Dr. Fuller and his team enrolled 198 pregnant women living with HIV who sought care at the Hospital Federal dos Servidores do Estado – a national reference center for USAID’s Prevention of Mother to Child Transmission strategic program – between October 2014 and October 2021.

Participants were divided into two primary cohorts: BMI less than 25 at enrollment (n = 74) or BMI of 25 or higher (n = 124), then further divided by timing of INSTI-based combined ART: 

• INSTI-naive: women using INSTI-based ART (raltegravir [Isentress] 400 mg twice per day or dolutegravir [Tivicay] 50 mg/day plus 2 non-nucleoside reverse transcriptase inhibitors – lamivudine plus tenofovir disoproxil fumarate or lamivudine plus zidovudine) for 4 weeks between baseline and near delivery.
• INSTI-experienced: women who became pregnant while using INSTIs for at least 6 months before conception. 

Among underweight/normal weight participants, 77% (n = 57) were INSTI-naive and 23% (n = 17) INSTI-experienced, and among overweight/obese participants, 81.5% (n = 101) were INSTI-naive, and 18.5% (n = 23) were experienced.

Maternal age, which did not differ significantly by BMI or treatment experience, was a median of 28 years, and most participants were non-White. All participants were virally suppressed near delivery.

Study findings, which were published online  in HIV Medicine, highlighted that median weight near delivery in participants who were overweight/obese at baseline was similar regardless of whether they were treatment-experienced (90 kg [198 lb]) or treatment-naive (82.3 kg [181 lb]), P = .026.

However, participants who were underweight/normal weight who were INSTI-naive had significantly higher rates of gestational weight gain (31.5%, 18/57), compared with those of underweight/normal weight who were INSTI-experienced (11.8%, 2/17), P = .004. Notably, this gain was significant in all categories of change (that is, low < 0.18 kg/week, normal 0.18-0.59 kg/week), and high > 0.59 kg/week).

“One of the things that we took away was that this weight gain is primarily happening with women who are starting INSTIs,” said Dr. Fuller. 

“The data suggest that [it] might be temporary in the sense that there’s not going to be continuous weight gain but that it will probably approach some type of horizontal asymptote,” he added.

Although obstetric and neonatal outcomes were secondary measures, the investigators did not observe any significantly different outcomes when comparing the groups, and there were no stillbirths, neonatal deaths, or macrosomia.

Preterm delivery rates in underweight/normal weight participants who were INSTI-experienced (11.8%, 2/17) and INSTI-naive (5.3%, 3/57) were similar to overweight/obese participants who were INSTI-experienced (13%, 3/23) and INSTI-naive (6.9%, 7/101).

The same was true for low birthweight.

Still, the study appears to raise more questions than it answers, Sigal Yawetz, MD, an infectious disease specialist at Brigham and Women’s Hospital, Boston, said in an interview – a factor that she said is common also in some of the more recent randomized controlled studies, such as IMPAACT PROMISE.

Dr. Yawetz, who was not involved in the study, also noted, “The groups were small, so comparisons within the groups are difficult, and so many people were excluded that it’s hard to know if there were adverse outcomes related to this ... It’s very confounded.”

The World Health Organization estimates that there are roughly 1.3 million pregnant women with HIV, 81% of whom are on antiretroviral therapy. Although the literature continues to evolve, data suggest that in general, Black women are at greater risk for gestational weight gain.

“We have to remember that women who gain excess weight in pregnancy are still going to be with this weight following pregnancy as well,” Dr. Yawetz said. “So, it might impact their pregnancy but also their health after delivery and for subsequent pregnancies, which we don’t have data for yet.”

Dr. Fuller agrees that more data are needed and mentioned that the team plans to study this further, ideally with larger sample sizes.

Yet, despite the lingering questions, there is a silver lining, one that Dr. Yawetz was emphatic about.

“I really welcome people doing studies on this because we really need the data. By far, integrase inhibitors are the first-line regimen all over the world for pregnant women, and if you look at the gestalt or full picture, this is the best regimen to give pregnant women,” she said.

Dr. Fuller and Dr. Yawetz report no relevant financial relationships. The study was independently supported.

A version of this article first appeared on Medscape.com.

Fort Worth, Tex. – A case decision made by Texas U.S. District Judge Reed Charles O’Connor that will allow employers to deny health care insurance coverage for HIV preexposure prophylaxis (PrEP) is already provoking HIV activists, medical associations, nonprofits, and patients.

As this news organization first reported in August, the class action suit (Kelley v. Azar) has a broader goal – to dismantle the Affordable Care Act using the argument that many of the preventive services it covers, including PrEP, violate the Religious Freedom Restoration Act.

“Judge O’Connor has a long history of issuing rulings against the Affordable Care Act and LGBT individuals, and we expect the case to be successfully appealed as has been the case with his previous discriminatory decisions,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington, in a prepared statement issued shortly after the ruling.

“To single out PrEP, which are FDA approved drugs that effectively prevent HIV, and conclude that its coverage violates the religious freedom of certain individuals, is plain wrong, highly discriminatory, and impedes the public health of our nation,” he said. 

PrEP is not just for men who have sex with men. According to the Centers for Disease Control and Prevention, more than 1 million Americans could benefit from PrEP, and roughly 20% are heterosexual women – a fact both Mr. Schmid and the HIV Medicine Association pointed out in response to Judge O’Connor’s ruling.

“Denying access to PrEP threatens the health of more than 1.2 million Americans who could benefit from this potentially life saving intervention,” stated Marwan Haddad, MD, MPH, chair of the HIV Medicine Association, in a press release issued by the organization.

“This ruling is yet one more instance of unacceptable interference in scientific, evidence-based health care practices that must remain within the sanctity of the provider-patient relationship,” she said.

The ruling is also outside what is normally considered religious “conscientious objection.”

While the American Medical Association supports the rights of physicians to act in accordance with conscience, medical ethicists like Abram Brummett, PhD, assistant professor, department of foundational medical studies, Oakland University, Rochester, Mich., previously told this news organization that this ruling actually reflects a phenomenon known as “conscience creep” – that is, the way conscientious objection creeps outside traditional contexts like abortion, sterilization, and organ transplantation.

Incidentally, the case is not yet completed; Judge O’Connor still has to decide on challenges to contraceptives and HPV mandates. He has requested that defendants and plaintiffs file a supplemental briefing before he makes a final decision.

Regardless of how it plays out, it is unclear whether the U.S. Department of Health and Human Services will appeal.

A version of this article first appeared on Medscape.com.

Fort Worth, Tex. – A case decision made by Texas U.S. District Judge Reed Charles O’Connor that will allow employers to deny health care insurance coverage for HIV preexposure prophylaxis (PrEP) is already provoking HIV activists, medical associations, nonprofits, and patients.

As this news organization first reported in August, the class action suit (Kelley v. Azar) has a broader goal – to dismantle the Affordable Care Act using the argument that many of the preventive services it covers, including PrEP, violate the Religious Freedom Restoration Act.

“Judge O’Connor has a long history of issuing rulings against the Affordable Care Act and LGBT individuals, and we expect the case to be successfully appealed as has been the case with his previous discriminatory decisions,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington, in a prepared statement issued shortly after the ruling.

“To single out PrEP, which are FDA approved drugs that effectively prevent HIV, and conclude that its coverage violates the religious freedom of certain individuals, is plain wrong, highly discriminatory, and impedes the public health of our nation,” he said. 

PrEP is not just for men who have sex with men. According to the Centers for Disease Control and Prevention, more than 1 million Americans could benefit from PrEP, and roughly 20% are heterosexual women – a fact both Mr. Schmid and the HIV Medicine Association pointed out in response to Judge O’Connor’s ruling.

“Denying access to PrEP threatens the health of more than 1.2 million Americans who could benefit from this potentially life saving intervention,” stated Marwan Haddad, MD, MPH, chair of the HIV Medicine Association, in a press release issued by the organization.

“This ruling is yet one more instance of unacceptable interference in scientific, evidence-based health care practices that must remain within the sanctity of the provider-patient relationship,” she said.

The ruling is also outside what is normally considered religious “conscientious objection.”

While the American Medical Association supports the rights of physicians to act in accordance with conscience, medical ethicists like Abram Brummett, PhD, assistant professor, department of foundational medical studies, Oakland University, Rochester, Mich., previously told this news organization that this ruling actually reflects a phenomenon known as “conscience creep” – that is, the way conscientious objection creeps outside traditional contexts like abortion, sterilization, and organ transplantation.

Incidentally, the case is not yet completed; Judge O’Connor still has to decide on challenges to contraceptives and HPV mandates. He has requested that defendants and plaintiffs file a supplemental briefing before he makes a final decision.

Regardless of how it plays out, it is unclear whether the U.S. Department of Health and Human Services will appeal.

A version of this article first appeared on Medscape.com.

Fort Worth, Tex. – A case decision made by Texas U.S. District Judge Reed Charles O’Connor that will allow employers to deny health care insurance coverage for HIV preexposure prophylaxis (PrEP) is already provoking HIV activists, medical associations, nonprofits, and patients.

As this news organization first reported in August, the class action suit (Kelley v. Azar) has a broader goal – to dismantle the Affordable Care Act using the argument that many of the preventive services it covers, including PrEP, violate the Religious Freedom Restoration Act.

“Judge O’Connor has a long history of issuing rulings against the Affordable Care Act and LGBT individuals, and we expect the case to be successfully appealed as has been the case with his previous discriminatory decisions,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington, in a prepared statement issued shortly after the ruling.

“To single out PrEP, which are FDA approved drugs that effectively prevent HIV, and conclude that its coverage violates the religious freedom of certain individuals, is plain wrong, highly discriminatory, and impedes the public health of our nation,” he said. 

PrEP is not just for men who have sex with men. According to the Centers for Disease Control and Prevention, more than 1 million Americans could benefit from PrEP, and roughly 20% are heterosexual women – a fact both Mr. Schmid and the HIV Medicine Association pointed out in response to Judge O’Connor’s ruling.

“Denying access to PrEP threatens the health of more than 1.2 million Americans who could benefit from this potentially life saving intervention,” stated Marwan Haddad, MD, MPH, chair of the HIV Medicine Association, in a press release issued by the organization.

“This ruling is yet one more instance of unacceptable interference in scientific, evidence-based health care practices that must remain within the sanctity of the provider-patient relationship,” she said.

The ruling is also outside what is normally considered religious “conscientious objection.”

While the American Medical Association supports the rights of physicians to act in accordance with conscience, medical ethicists like Abram Brummett, PhD, assistant professor, department of foundational medical studies, Oakland University, Rochester, Mich., previously told this news organization that this ruling actually reflects a phenomenon known as “conscience creep” – that is, the way conscientious objection creeps outside traditional contexts like abortion, sterilization, and organ transplantation.

Incidentally, the case is not yet completed; Judge O’Connor still has to decide on challenges to contraceptives and HPV mandates. He has requested that defendants and plaintiffs file a supplemental briefing before he makes a final decision.

Regardless of how it plays out, it is unclear whether the U.S. Department of Health and Human Services will appeal.

A version of this article first appeared on Medscape.com.

Monkeypox. Polio. Covid. A quick glance at the news on any given day seems to indicate that outbreaks, epidemics, and perhaps even pandemics are increasing in frequency.

Granted, these types of events are hardly new; from the plagues of the 5th and 13th centuries to the Spanish flu in the 20th century and SARS-CoV-2 today, they’ve been with us from time immemorial. 

What appears to be different, however, is not their frequency, but their intensity, with research reinforcing that we may be facing unique challenges and smaller windows to intervene as we move forward.

Findings from a modeling study, published in 2021 in Proceedings of the National Academy of Sciences, underscore that without effective intervention, the probability of extreme events like COVID-19 will likely increase threefold in the coming decades.

“The fact is, pandemic preparedness is not something that people have valued or thought of as important, or paid much attention to,” Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, told this news organization.

“It’s all been based on some unusual cluster of cases that were causing severe disease and overwhelming local authorities. So often, like Indiana Jones, somebody got dispatched to deal with an outbreak,” Dr. Adalja said.

In a perfect post-COVID world, government bodies, scientists, clinicians, and others would cross silos to coordinate pandemic prevention, not just preparedness. The public would trust those who carry the title “public health” in their daily responsibilities, and in turn, public health experts would get back to their core responsibility – infectious disease preparedness – the role they were initially assigned following Europe’s Black Death during the 14th century. Instead, the world finds itself at a crossroads, with emerging and reemerging infectious disease outbreaks that on the surface appear to arise haphazardly but in reality are the result of decades of reaction and containment policies aimed at putting out fires, not addressing their cause.

Dr. Adalja noted that only when the threat of biological weapons became a reality in the mid-2000s was there a realization that economies of scale could be exploited by merging interests and efforts to develop health security medical countermeasures. For example, it encouraged governments to more closely integrate agencies like the Biomedical Advanced Research and Development Authority and infectious disease research organizations and individuals.

Still, while significant strides have been made in certain areas, the ongoing COVID-19 pandemic has revealed substantial weaknesses remaining in public and private health systems, as well as major gaps in infectious disease preparedness.
 

The role of spillover events

No matter whom you ask, scientists, public health and conservation experts, and infectious disease clinicians all point to one of the most important threats to human health. As Walt Kelly’s Pogo famously put it, “We have met the enemy, and he is us.”

“The reason why these outbreaks of novel infectious diseases are increasingly occurring is because of human-driven environmental change, particularly land use, unsafe practices when raising farmed animals, and commercial wildlife markets,” Neil M. Vora, MD, a physician specializing in pandemic prevention at Conservation International and a former Centers for Disease Control and Prevention epidemic intelligence officer, said in an interview.

In fact, more than 60% of emerging infections and diseases are due to these “spillover events” (zoonotic spillover) that occur when pathogens that commonly circulate in wildlife jump over to new, human hosts.

Several examples come to mind.

COVID-19 may have begun as an enzootic virus from two undetermined animals, using the Huanan Seafood Market as a possible intermediate reservoir, according to a July 26 preprint in the journal Science. 

Likewise, while the Ebola virus was originally attributed to deforestation efforts to create palm oil (which allowed fruit bat carriers to transfer the virus to humans), recent research suggests that bats dwelling in the walls of human dwellings and hospitals are responsible for the 2018 outbreak in the Democratic Republic of Congo. 

(Incidentally, just this week, a new Ebola case was confirmed in Eastern Congo, and it has been genetically linked to the previous outbreak, despite that outbreak having been declared over in early July.)

“When we clear forests, we create opportunities for humans to live alongside the forest edge and displace wildlife. There’s evidence that shows when [these] biodiverse areas are cleared, specialist species that evolved to live in the forests first start to disappear, whereas generalist species – rodents and bats – continue to survive and are able to carry pathogens that can be passed on to humans,” Dr. Vora explained.

So far, China’s outbreak of the novel Langya henipavirus is believed to have spread (either directly or indirectly) by rodents and shrews, according to reports from public health authorities like the European Centre for Disease Prevention and Control, which is currently monitoring the situation. 

Yet, an overreliance on surveillance and containment only perpetuates what Dr. Vora says are cycles of panic and neglect.

“We saw it with Ebola in 2015, in 2016 to 2017 with Zika, you see it with tuberculosis, with sexually transmitted infections, and with COVID. You have policymakers working on solutions, and once they think that they’ve fixed the problem, they’re going to move on to the next crisis.”

It’s also a question of equity.

Reports detailing the reemergence of monkeypox in Nigeria in 2017 were largely ignored, despite the fact that the United States assisted in diagnosing an early case in an 11-year-old boy. At the time, it was clear that the virus was spreading by human-to-human transmission versus animal-to-human transmission, something that had not been seen previously. 

“The current model [is] waiting for pathogens to spill over and then [continuing] to spread signals that rich countries are tolerant of these outbreaks so long as they don’t grow into epidemics or pandemics,” Dr. Vora said.

This model is clearly broken; roughly 5 years after Nigeria reported the resurgence of monkeypox, the United States has more than 14,000 confirmed cases, which represents more than a quarter of the total number of cases reported worldwide. 
 

Public health on the brink

I’s difficult to imagine a future without outbreaks and more pandemics, and if experts are to be believed, we are ill-prepared. 

“I think that we are in a situation where this is a major threat, and people have become complacent about it,” said Dr. Adalja, who noted that we should be asking ourselves if the “government is actually in a position to be able to respond in a way that we need them to or is [that response] tied up in bureaucracy and inefficiency?”

COVID-19 should have been seen as a wake-up call, and many of those deaths were preventable. “With monkeypox, they’re faltering; it should have been a layup, not a disaster,” he emphasized.

Ellen Eaton, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, also pointed to the reality that by the time COVID-19 reached North America, the United States had already moved away from the model of the public health department as the epicenter of knowledge, education, awareness, and, ironically, public health.

“Thinking about my community, very few people knew the face and name of our local and state health officers,” she told this news organization.  

“There was just this inherent mistrust of these people. If you add in a lot of talking heads, a lot of politicians and messaging from non-experts that countered what was coming out of our public health agencies early, you had this huge disconnect; in the South, it was the perfect storm for vaccine hesitancy.”

At last count, this perfect storm has led to 1.46 million COVID cases and just over 20,000 deaths – many of which were preventable – in Alabama alone. 

“In certain parts of America, we were starting with a broken system with limited resources and few providers,” Dr. Eaton explained.

Dr. Eaton said that a lot of fields, not just medicine and public health, have finite resources that have been stretched to capacity by COVID, and now monkeypox, and wondered what was next as we’re headed into autumn and influenza season. But she also mentioned the tremendous implications of climate change on infectious diseases and community health and wellness.

“There’s a tremendous need to have the ability to survey not just humans but also how the disease burden in our environment that is fluctuating with climate change is going to impact communities in really important ways,” Dr. Eaton said. 
 

Upstream prevention

Dr. Vora said he could not agree more and believes that upstream prevention holds the key. 

“We have to make sure while there’s tension on this issue that the right solutions are implemented,” he said. 

In coming years, postspillover containment strategies – vaccine research and development and strengthening health care surveillance, for example – are likely to become inadequate.

“We saw it with COVID and we are seeing it again with monkeypox,” Dr. Vora said. “We also have to invest further upstream to prevent spillovers in the first place, for example, by addressing deforestation, commercial wildlife markets and trade, [and] infection control when raising farm animals.”

“The thing is, when you invest in those upstream solutions, you are also mitigating climate change and loss of biodiversity. I’m not saying that we should not invest in postspillover containment efforts; we’re never going to contain every spillover. But we also have to invest in prevention,” he added.

In a piece published in Nature, Dr. Vora and his coauthors acknowledge that several international bodies such as the World Health Organization and G7 have invested in initiatives to facilitate coordinated, global responses to climate change, pandemic preparedness, and response. But they point out that these efforts fail to “explicitly address the negative feedback cycle between environmental degradation, wildlife exploitation, and the emergence of pathogens.”

“Environmental conservation is no longer a left-wing fringe issue, it’s moving into public consciousness, and ... it is public health,” Dr. Vora said. “When we destroy nature, we’re destroying our own ability to survive.”

Dr. Adalja, Dr. Vora, and Dr. Eaton report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Monkeypox. Polio. Covid. A quick glance at the news on any given day seems to indicate that outbreaks, epidemics, and perhaps even pandemics are increasing in frequency.

Granted, these types of events are hardly new; from the plagues of the 5th and 13th centuries to the Spanish flu in the 20th century and SARS-CoV-2 today, they’ve been with us from time immemorial. 

What appears to be different, however, is not their frequency, but their intensity, with research reinforcing that we may be facing unique challenges and smaller windows to intervene as we move forward.

Findings from a modeling study, published in 2021 in Proceedings of the National Academy of Sciences, underscore that without effective intervention, the probability of extreme events like COVID-19 will likely increase threefold in the coming decades.

“The fact is, pandemic preparedness is not something that people have valued or thought of as important, or paid much attention to,” Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, told this news organization.

“It’s all been based on some unusual cluster of cases that were causing severe disease and overwhelming local authorities. So often, like Indiana Jones, somebody got dispatched to deal with an outbreak,” Dr. Adalja said.

In a perfect post-COVID world, government bodies, scientists, clinicians, and others would cross silos to coordinate pandemic prevention, not just preparedness. The public would trust those who carry the title “public health” in their daily responsibilities, and in turn, public health experts would get back to their core responsibility – infectious disease preparedness – the role they were initially assigned following Europe’s Black Death during the 14th century. Instead, the world finds itself at a crossroads, with emerging and reemerging infectious disease outbreaks that on the surface appear to arise haphazardly but in reality are the result of decades of reaction and containment policies aimed at putting out fires, not addressing their cause.

Dr. Adalja noted that only when the threat of biological weapons became a reality in the mid-2000s was there a realization that economies of scale could be exploited by merging interests and efforts to develop health security medical countermeasures. For example, it encouraged governments to more closely integrate agencies like the Biomedical Advanced Research and Development Authority and infectious disease research organizations and individuals.

Still, while significant strides have been made in certain areas, the ongoing COVID-19 pandemic has revealed substantial weaknesses remaining in public and private health systems, as well as major gaps in infectious disease preparedness.
 

The role of spillover events

No matter whom you ask, scientists, public health and conservation experts, and infectious disease clinicians all point to one of the most important threats to human health. As Walt Kelly’s Pogo famously put it, “We have met the enemy, and he is us.”

“The reason why these outbreaks of novel infectious diseases are increasingly occurring is because of human-driven environmental change, particularly land use, unsafe practices when raising farmed animals, and commercial wildlife markets,” Neil M. Vora, MD, a physician specializing in pandemic prevention at Conservation International and a former Centers for Disease Control and Prevention epidemic intelligence officer, said in an interview.

In fact, more than 60% of emerging infections and diseases are due to these “spillover events” (zoonotic spillover) that occur when pathogens that commonly circulate in wildlife jump over to new, human hosts.

Several examples come to mind.

COVID-19 may have begun as an enzootic virus from two undetermined animals, using the Huanan Seafood Market as a possible intermediate reservoir, according to a July 26 preprint in the journal Science. 

Likewise, while the Ebola virus was originally attributed to deforestation efforts to create palm oil (which allowed fruit bat carriers to transfer the virus to humans), recent research suggests that bats dwelling in the walls of human dwellings and hospitals are responsible for the 2018 outbreak in the Democratic Republic of Congo. 

(Incidentally, just this week, a new Ebola case was confirmed in Eastern Congo, and it has been genetically linked to the previous outbreak, despite that outbreak having been declared over in early July.)

“When we clear forests, we create opportunities for humans to live alongside the forest edge and displace wildlife. There’s evidence that shows when [these] biodiverse areas are cleared, specialist species that evolved to live in the forests first start to disappear, whereas generalist species – rodents and bats – continue to survive and are able to carry pathogens that can be passed on to humans,” Dr. Vora explained.

So far, China’s outbreak of the novel Langya henipavirus is believed to have spread (either directly or indirectly) by rodents and shrews, according to reports from public health authorities like the European Centre for Disease Prevention and Control, which is currently monitoring the situation. 

Yet, an overreliance on surveillance and containment only perpetuates what Dr. Vora says are cycles of panic and neglect.

“We saw it with Ebola in 2015, in 2016 to 2017 with Zika, you see it with tuberculosis, with sexually transmitted infections, and with COVID. You have policymakers working on solutions, and once they think that they’ve fixed the problem, they’re going to move on to the next crisis.”

It’s also a question of equity.

Reports detailing the reemergence of monkeypox in Nigeria in 2017 were largely ignored, despite the fact that the United States assisted in diagnosing an early case in an 11-year-old boy. At the time, it was clear that the virus was spreading by human-to-human transmission versus animal-to-human transmission, something that had not been seen previously. 

“The current model [is] waiting for pathogens to spill over and then [continuing] to spread signals that rich countries are tolerant of these outbreaks so long as they don’t grow into epidemics or pandemics,” Dr. Vora said.

This model is clearly broken; roughly 5 years after Nigeria reported the resurgence of monkeypox, the United States has more than 14,000 confirmed cases, which represents more than a quarter of the total number of cases reported worldwide. 
 

Public health on the brink

I’s difficult to imagine a future without outbreaks and more pandemics, and if experts are to be believed, we are ill-prepared. 

“I think that we are in a situation where this is a major threat, and people have become complacent about it,” said Dr. Adalja, who noted that we should be asking ourselves if the “government is actually in a position to be able to respond in a way that we need them to or is [that response] tied up in bureaucracy and inefficiency?”

COVID-19 should have been seen as a wake-up call, and many of those deaths were preventable. “With monkeypox, they’re faltering; it should have been a layup, not a disaster,” he emphasized.

Ellen Eaton, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, also pointed to the reality that by the time COVID-19 reached North America, the United States had already moved away from the model of the public health department as the epicenter of knowledge, education, awareness, and, ironically, public health.

“Thinking about my community, very few people knew the face and name of our local and state health officers,” she told this news organization.  

“There was just this inherent mistrust of these people. If you add in a lot of talking heads, a lot of politicians and messaging from non-experts that countered what was coming out of our public health agencies early, you had this huge disconnect; in the South, it was the perfect storm for vaccine hesitancy.”

At last count, this perfect storm has led to 1.46 million COVID cases and just over 20,000 deaths – many of which were preventable – in Alabama alone. 

“In certain parts of America, we were starting with a broken system with limited resources and few providers,” Dr. Eaton explained.

Dr. Eaton said that a lot of fields, not just medicine and public health, have finite resources that have been stretched to capacity by COVID, and now monkeypox, and wondered what was next as we’re headed into autumn and influenza season. But she also mentioned the tremendous implications of climate change on infectious diseases and community health and wellness.

“There’s a tremendous need to have the ability to survey not just humans but also how the disease burden in our environment that is fluctuating with climate change is going to impact communities in really important ways,” Dr. Eaton said. 
 

Upstream prevention

Dr. Vora said he could not agree more and believes that upstream prevention holds the key. 

“We have to make sure while there’s tension on this issue that the right solutions are implemented,” he said. 

In coming years, postspillover containment strategies – vaccine research and development and strengthening health care surveillance, for example – are likely to become inadequate.

“We saw it with COVID and we are seeing it again with monkeypox,” Dr. Vora said. “We also have to invest further upstream to prevent spillovers in the first place, for example, by addressing deforestation, commercial wildlife markets and trade, [and] infection control when raising farm animals.”

“The thing is, when you invest in those upstream solutions, you are also mitigating climate change and loss of biodiversity. I’m not saying that we should not invest in postspillover containment efforts; we’re never going to contain every spillover. But we also have to invest in prevention,” he added.

In a piece published in Nature, Dr. Vora and his coauthors acknowledge that several international bodies such as the World Health Organization and G7 have invested in initiatives to facilitate coordinated, global responses to climate change, pandemic preparedness, and response. But they point out that these efforts fail to “explicitly address the negative feedback cycle between environmental degradation, wildlife exploitation, and the emergence of pathogens.”

“Environmental conservation is no longer a left-wing fringe issue, it’s moving into public consciousness, and ... it is public health,” Dr. Vora said. “When we destroy nature, we’re destroying our own ability to survive.”

Dr. Adalja, Dr. Vora, and Dr. Eaton report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Monkeypox. Polio. Covid. A quick glance at the news on any given day seems to indicate that outbreaks, epidemics, and perhaps even pandemics are increasing in frequency.

Granted, these types of events are hardly new; from the plagues of the 5th and 13th centuries to the Spanish flu in the 20th century and SARS-CoV-2 today, they’ve been with us from time immemorial. 

What appears to be different, however, is not their frequency, but their intensity, with research reinforcing that we may be facing unique challenges and smaller windows to intervene as we move forward.

Findings from a modeling study, published in 2021 in Proceedings of the National Academy of Sciences, underscore that without effective intervention, the probability of extreme events like COVID-19 will likely increase threefold in the coming decades.

“The fact is, pandemic preparedness is not something that people have valued or thought of as important, or paid much attention to,” Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, told this news organization.

“It’s all been based on some unusual cluster of cases that were causing severe disease and overwhelming local authorities. So often, like Indiana Jones, somebody got dispatched to deal with an outbreak,” Dr. Adalja said.

In a perfect post-COVID world, government bodies, scientists, clinicians, and others would cross silos to coordinate pandemic prevention, not just preparedness. The public would trust those who carry the title “public health” in their daily responsibilities, and in turn, public health experts would get back to their core responsibility – infectious disease preparedness – the role they were initially assigned following Europe’s Black Death during the 14th century. Instead, the world finds itself at a crossroads, with emerging and reemerging infectious disease outbreaks that on the surface appear to arise haphazardly but in reality are the result of decades of reaction and containment policies aimed at putting out fires, not addressing their cause.

Dr. Adalja noted that only when the threat of biological weapons became a reality in the mid-2000s was there a realization that economies of scale could be exploited by merging interests and efforts to develop health security medical countermeasures. For example, it encouraged governments to more closely integrate agencies like the Biomedical Advanced Research and Development Authority and infectious disease research organizations and individuals.

Still, while significant strides have been made in certain areas, the ongoing COVID-19 pandemic has revealed substantial weaknesses remaining in public and private health systems, as well as major gaps in infectious disease preparedness.
 

The role of spillover events

No matter whom you ask, scientists, public health and conservation experts, and infectious disease clinicians all point to one of the most important threats to human health. As Walt Kelly’s Pogo famously put it, “We have met the enemy, and he is us.”

“The reason why these outbreaks of novel infectious diseases are increasingly occurring is because of human-driven environmental change, particularly land use, unsafe practices when raising farmed animals, and commercial wildlife markets,” Neil M. Vora, MD, a physician specializing in pandemic prevention at Conservation International and a former Centers for Disease Control and Prevention epidemic intelligence officer, said in an interview.

In fact, more than 60% of emerging infections and diseases are due to these “spillover events” (zoonotic spillover) that occur when pathogens that commonly circulate in wildlife jump over to new, human hosts.

Several examples come to mind.

COVID-19 may have begun as an enzootic virus from two undetermined animals, using the Huanan Seafood Market as a possible intermediate reservoir, according to a July 26 preprint in the journal Science. 

Likewise, while the Ebola virus was originally attributed to deforestation efforts to create palm oil (which allowed fruit bat carriers to transfer the virus to humans), recent research suggests that bats dwelling in the walls of human dwellings and hospitals are responsible for the 2018 outbreak in the Democratic Republic of Congo. 

(Incidentally, just this week, a new Ebola case was confirmed in Eastern Congo, and it has been genetically linked to the previous outbreak, despite that outbreak having been declared over in early July.)

“When we clear forests, we create opportunities for humans to live alongside the forest edge and displace wildlife. There’s evidence that shows when [these] biodiverse areas are cleared, specialist species that evolved to live in the forests first start to disappear, whereas generalist species – rodents and bats – continue to survive and are able to carry pathogens that can be passed on to humans,” Dr. Vora explained.

So far, China’s outbreak of the novel Langya henipavirus is believed to have spread (either directly or indirectly) by rodents and shrews, according to reports from public health authorities like the European Centre for Disease Prevention and Control, which is currently monitoring the situation. 

Yet, an overreliance on surveillance and containment only perpetuates what Dr. Vora says are cycles of panic and neglect.

“We saw it with Ebola in 2015, in 2016 to 2017 with Zika, you see it with tuberculosis, with sexually transmitted infections, and with COVID. You have policymakers working on solutions, and once they think that they’ve fixed the problem, they’re going to move on to the next crisis.”

It’s also a question of equity.

Reports detailing the reemergence of monkeypox in Nigeria in 2017 were largely ignored, despite the fact that the United States assisted in diagnosing an early case in an 11-year-old boy. At the time, it was clear that the virus was spreading by human-to-human transmission versus animal-to-human transmission, something that had not been seen previously. 

“The current model [is] waiting for pathogens to spill over and then [continuing] to spread signals that rich countries are tolerant of these outbreaks so long as they don’t grow into epidemics or pandemics,” Dr. Vora said.

This model is clearly broken; roughly 5 years after Nigeria reported the resurgence of monkeypox, the United States has more than 14,000 confirmed cases, which represents more than a quarter of the total number of cases reported worldwide. 
 

Public health on the brink

I’s difficult to imagine a future without outbreaks and more pandemics, and if experts are to be believed, we are ill-prepared. 

“I think that we are in a situation where this is a major threat, and people have become complacent about it,” said Dr. Adalja, who noted that we should be asking ourselves if the “government is actually in a position to be able to respond in a way that we need them to or is [that response] tied up in bureaucracy and inefficiency?”

COVID-19 should have been seen as a wake-up call, and many of those deaths were preventable. “With monkeypox, they’re faltering; it should have been a layup, not a disaster,” he emphasized.

Ellen Eaton, MD, associate professor of infectious diseases at the University of Alabama at Birmingham, also pointed to the reality that by the time COVID-19 reached North America, the United States had already moved away from the model of the public health department as the epicenter of knowledge, education, awareness, and, ironically, public health.

“Thinking about my community, very few people knew the face and name of our local and state health officers,” she told this news organization.  

“There was just this inherent mistrust of these people. If you add in a lot of talking heads, a lot of politicians and messaging from non-experts that countered what was coming out of our public health agencies early, you had this huge disconnect; in the South, it was the perfect storm for vaccine hesitancy.”

At last count, this perfect storm has led to 1.46 million COVID cases and just over 20,000 deaths – many of which were preventable – in Alabama alone. 

“In certain parts of America, we were starting with a broken system with limited resources and few providers,” Dr. Eaton explained.

Dr. Eaton said that a lot of fields, not just medicine and public health, have finite resources that have been stretched to capacity by COVID, and now monkeypox, and wondered what was next as we’re headed into autumn and influenza season. But she also mentioned the tremendous implications of climate change on infectious diseases and community health and wellness.

“There’s a tremendous need to have the ability to survey not just humans but also how the disease burden in our environment that is fluctuating with climate change is going to impact communities in really important ways,” Dr. Eaton said. 
 

Upstream prevention

Dr. Vora said he could not agree more and believes that upstream prevention holds the key. 

“We have to make sure while there’s tension on this issue that the right solutions are implemented,” he said. 

In coming years, postspillover containment strategies – vaccine research and development and strengthening health care surveillance, for example – are likely to become inadequate.

“We saw it with COVID and we are seeing it again with monkeypox,” Dr. Vora said. “We also have to invest further upstream to prevent spillovers in the first place, for example, by addressing deforestation, commercial wildlife markets and trade, [and] infection control when raising farm animals.”

“The thing is, when you invest in those upstream solutions, you are also mitigating climate change and loss of biodiversity. I’m not saying that we should not invest in postspillover containment efforts; we’re never going to contain every spillover. But we also have to invest in prevention,” he added.

In a piece published in Nature, Dr. Vora and his coauthors acknowledge that several international bodies such as the World Health Organization and G7 have invested in initiatives to facilitate coordinated, global responses to climate change, pandemic preparedness, and response. But they point out that these efforts fail to “explicitly address the negative feedback cycle between environmental degradation, wildlife exploitation, and the emergence of pathogens.”

“Environmental conservation is no longer a left-wing fringe issue, it’s moving into public consciousness, and ... it is public health,” Dr. Vora said. “When we destroy nature, we’re destroying our own ability to survive.”

Dr. Adalja, Dr. Vora, and Dr. Eaton report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Young Black sexual-minority men (YBSMM) who experience sleep disturbance at least 3-4 times a week are much more likely to miss HIV pre-exposure prophylaxis (PrEP) doses than those who rarely report sleep disturbance, according to a new study published online in the journal AIDS and Behavior.

Sleep disturbance, poor cognitive processing, and memory function deficits go hand in hand, especially among people living with HIV. 

Data have suggested that poor sleep might be an important factor in common neurocognitive complaints and overall health outcomes, especially among older adults with HIV. But few studies have examined the role that sleep quality might play in driving health behaviors around prevention and PrEP adherence, especially among YBSMM, who are at highest risk for acquiring new HIV infections.

Commonly cited reasons for suboptimal HIV prevention efforts within this population often include stigma, mistrust of the medical system, and a lack of culturally appropriate care.

“We make a lot of assumptions about young people and their brains and their ability to remember things, namely [that] they should be better than older adults at remembering to take medications,” lead study investigator Jade Pagkas-Bather, MD, an infectious disease specialist at University of Chicago Medicine, told this news organization. 

“In reality, many young people are not used to taking medications, [especially] for a disease that they do not have.”
 

Too many pills, too little sleep

The researchers examined data collected from participants in the Neighborhoods and Networks Cohort Study, Chicago, which looked at the role of social, contextual, network, and geospatial factors influencing HIV prevention and care in HIV-negative, cisgender YBSMM between 2018 and 2019. 

The investigators included 70 YBSMM participants who reported current PrEP use in the analysis. All were between the ages of 16 and 24 years, self-identified as African American or Black, were assigned male at birth, and reported at least one sexual encounter with a man or transgender woman in the previous 12 months.

Sleep was measured using the Patient Health Questionnaire-9 (PHQ-9) which includes a question on frequency of sleep disturbance (that is, trouble falling asleep, staying asleep, or sleeping too much) categorized as follows: less than 1 day (rarely or none of the time), 1-2 days (some or a little of the time), 3-4 days (occasionally or a moderate amount of time), or 5-7 days (all of the time).

Almost half (47.1%) of participants self-reported some or moderate sleep disturbance, with 8.6% having sleep disturbance all of the time. 

“One of the main findings was that poor sleep and having too many pills impacts people’s ability to remember to take their PrEP or is associated with missing PrEP doses,” explained Dr. Pagkas-Bather.

In adjusted models, YBSMM who reported moderate sleep disturbances cited having too many pills to take as the reason for missing or forgetting PrEP doses (adjusted odds ratio, 7.59; 95% confidence interval, 1.05-54.57), compared with peers who did not have sleep issues.

Depression was likewise an important factor. Participants who reported experiencing sleep disturbance all of the time and missing PrEP doses were also highly likely to be depressed (aOR, 11.30; 95% CI, 1.19-107.53).

“The PHQ-9 is a widely accepted measure looking at depression – and sleep as one symptom of depression,” explained Brooke Genkin Rogers, Ph.D., M.P.H., a research scientist and assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I. 

Dr. Rogers, who was not involved in the study, noted, “Sleep disturbance is a sign of poor physical or mental health, particularly in an otherwise younger, healthier population.” But Dr. Rogers also had questions about sleep duration (that is, too short or too long) and whether or not it also played a role in poor adherence, information that was not pursued within the study. 

“As a clinician, I see quite a few people who are young Black sexual minority men who are on PrEP, or on the converse side, people living with HIV and taking medications for HIV treatment. I would posit a guess that it’s not that people are necessarily sleeping too much, but there are other sorts of factors that interfere with being able to get 8 hours of sleep a night,” explained Dr. Pagkas-Bather.

They include structural issues like greater exposure to housing instability and neighborhood safety. 

However, Dr. Pagkas-Bather pointed to an even more critical factor influencing PrEP usage and adherence, one that she refers to as “Trickle Up HIV Care.”

“We can’t just come up with interventions, drugs, and studies and say, we have all of these options, anyone who wants them, come and get them,” she said. “We really need to work very hard at educating and encouraging populations who have no high-level need for prevention and treatment.”

As a clinician who works closely with the YBSMM population, Dr. Pagkas-Bather also shared that her patients have told her that they’ve asked for PrEP and have had providers turn them down because they weren’t comfortable prescribing PrEP or made assumptions about the kind of people who are on PrEP. 

“There are sometimes assumptions made about Black men and sexual promiscuity. And the data doesn’t bear that out. It’s not that Black men are having more sex than White men or any other man; it’s that the prevalence of HIV in the Black community is higher overall relative to the population,” noted Dr. Pagkas-Bather.

“We need a nuanced approach to examining these issues ... to take a look at multiple levels of influence on folks’ health and HIV risk,” said Dr. Rogers.

Both clinicians acknowledged that creative solutions have not been exhausted. 

“There’s a lot of opportunity if we sit down with communities and share in decisions around HIV treatment and prevention ... if we tap into the wealth and knowledge of the Black communities to prevent HIV,” concluded Dr. Pagkas-Bather.

Dr. Pagkas-Bather reports that she is a Gilead Sciences HIV Research Scholar awardee. Dr. Rogers reports receiving a scientific research grant from Gilead Sciences. 

A version of this article first appeared on Medscape.com.

Young Black sexual-minority men (YBSMM) who experience sleep disturbance at least 3-4 times a week are much more likely to miss HIV pre-exposure prophylaxis (PrEP) doses than those who rarely report sleep disturbance, according to a new study published online in the journal AIDS and Behavior.

Sleep disturbance, poor cognitive processing, and memory function deficits go hand in hand, especially among people living with HIV. 

Data have suggested that poor sleep might be an important factor in common neurocognitive complaints and overall health outcomes, especially among older adults with HIV. But few studies have examined the role that sleep quality might play in driving health behaviors around prevention and PrEP adherence, especially among YBSMM, who are at highest risk for acquiring new HIV infections.

Commonly cited reasons for suboptimal HIV prevention efforts within this population often include stigma, mistrust of the medical system, and a lack of culturally appropriate care.

“We make a lot of assumptions about young people and their brains and their ability to remember things, namely [that] they should be better than older adults at remembering to take medications,” lead study investigator Jade Pagkas-Bather, MD, an infectious disease specialist at University of Chicago Medicine, told this news organization. 

“In reality, many young people are not used to taking medications, [especially] for a disease that they do not have.”
 

Too many pills, too little sleep

The researchers examined data collected from participants in the Neighborhoods and Networks Cohort Study, Chicago, which looked at the role of social, contextual, network, and geospatial factors influencing HIV prevention and care in HIV-negative, cisgender YBSMM between 2018 and 2019. 

The investigators included 70 YBSMM participants who reported current PrEP use in the analysis. All were between the ages of 16 and 24 years, self-identified as African American or Black, were assigned male at birth, and reported at least one sexual encounter with a man or transgender woman in the previous 12 months.

Sleep was measured using the Patient Health Questionnaire-9 (PHQ-9) which includes a question on frequency of sleep disturbance (that is, trouble falling asleep, staying asleep, or sleeping too much) categorized as follows: less than 1 day (rarely or none of the time), 1-2 days (some or a little of the time), 3-4 days (occasionally or a moderate amount of time), or 5-7 days (all of the time).

Almost half (47.1%) of participants self-reported some or moderate sleep disturbance, with 8.6% having sleep disturbance all of the time. 

“One of the main findings was that poor sleep and having too many pills impacts people’s ability to remember to take their PrEP or is associated with missing PrEP doses,” explained Dr. Pagkas-Bather.

In adjusted models, YBSMM who reported moderate sleep disturbances cited having too many pills to take as the reason for missing or forgetting PrEP doses (adjusted odds ratio, 7.59; 95% confidence interval, 1.05-54.57), compared with peers who did not have sleep issues.

Depression was likewise an important factor. Participants who reported experiencing sleep disturbance all of the time and missing PrEP doses were also highly likely to be depressed (aOR, 11.30; 95% CI, 1.19-107.53).

“The PHQ-9 is a widely accepted measure looking at depression – and sleep as one symptom of depression,” explained Brooke Genkin Rogers, Ph.D., M.P.H., a research scientist and assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I. 

Dr. Rogers, who was not involved in the study, noted, “Sleep disturbance is a sign of poor physical or mental health, particularly in an otherwise younger, healthier population.” But Dr. Rogers also had questions about sleep duration (that is, too short or too long) and whether or not it also played a role in poor adherence, information that was not pursued within the study. 

“As a clinician, I see quite a few people who are young Black sexual minority men who are on PrEP, or on the converse side, people living with HIV and taking medications for HIV treatment. I would posit a guess that it’s not that people are necessarily sleeping too much, but there are other sorts of factors that interfere with being able to get 8 hours of sleep a night,” explained Dr. Pagkas-Bather.

They include structural issues like greater exposure to housing instability and neighborhood safety. 

However, Dr. Pagkas-Bather pointed to an even more critical factor influencing PrEP usage and adherence, one that she refers to as “Trickle Up HIV Care.”

“We can’t just come up with interventions, drugs, and studies and say, we have all of these options, anyone who wants them, come and get them,” she said. “We really need to work very hard at educating and encouraging populations who have no high-level need for prevention and treatment.”

As a clinician who works closely with the YBSMM population, Dr. Pagkas-Bather also shared that her patients have told her that they’ve asked for PrEP and have had providers turn them down because they weren’t comfortable prescribing PrEP or made assumptions about the kind of people who are on PrEP. 

“There are sometimes assumptions made about Black men and sexual promiscuity. And the data doesn’t bear that out. It’s not that Black men are having more sex than White men or any other man; it’s that the prevalence of HIV in the Black community is higher overall relative to the population,” noted Dr. Pagkas-Bather.

“We need a nuanced approach to examining these issues ... to take a look at multiple levels of influence on folks’ health and HIV risk,” said Dr. Rogers.

Both clinicians acknowledged that creative solutions have not been exhausted. 

“There’s a lot of opportunity if we sit down with communities and share in decisions around HIV treatment and prevention ... if we tap into the wealth and knowledge of the Black communities to prevent HIV,” concluded Dr. Pagkas-Bather.

Dr. Pagkas-Bather reports that she is a Gilead Sciences HIV Research Scholar awardee. Dr. Rogers reports receiving a scientific research grant from Gilead Sciences. 

A version of this article first appeared on Medscape.com.

Young Black sexual-minority men (YBSMM) who experience sleep disturbance at least 3-4 times a week are much more likely to miss HIV pre-exposure prophylaxis (PrEP) doses than those who rarely report sleep disturbance, according to a new study published online in the journal AIDS and Behavior.

Sleep disturbance, poor cognitive processing, and memory function deficits go hand in hand, especially among people living with HIV. 

Data have suggested that poor sleep might be an important factor in common neurocognitive complaints and overall health outcomes, especially among older adults with HIV. But few studies have examined the role that sleep quality might play in driving health behaviors around prevention and PrEP adherence, especially among YBSMM, who are at highest risk for acquiring new HIV infections.

Commonly cited reasons for suboptimal HIV prevention efforts within this population often include stigma, mistrust of the medical system, and a lack of culturally appropriate care.

“We make a lot of assumptions about young people and their brains and their ability to remember things, namely [that] they should be better than older adults at remembering to take medications,” lead study investigator Jade Pagkas-Bather, MD, an infectious disease specialist at University of Chicago Medicine, told this news organization. 

“In reality, many young people are not used to taking medications, [especially] for a disease that they do not have.”
 

Too many pills, too little sleep

The researchers examined data collected from participants in the Neighborhoods and Networks Cohort Study, Chicago, which looked at the role of social, contextual, network, and geospatial factors influencing HIV prevention and care in HIV-negative, cisgender YBSMM between 2018 and 2019. 

The investigators included 70 YBSMM participants who reported current PrEP use in the analysis. All were between the ages of 16 and 24 years, self-identified as African American or Black, were assigned male at birth, and reported at least one sexual encounter with a man or transgender woman in the previous 12 months.

Sleep was measured using the Patient Health Questionnaire-9 (PHQ-9) which includes a question on frequency of sleep disturbance (that is, trouble falling asleep, staying asleep, or sleeping too much) categorized as follows: less than 1 day (rarely or none of the time), 1-2 days (some or a little of the time), 3-4 days (occasionally or a moderate amount of time), or 5-7 days (all of the time).

Almost half (47.1%) of participants self-reported some or moderate sleep disturbance, with 8.6% having sleep disturbance all of the time. 

“One of the main findings was that poor sleep and having too many pills impacts people’s ability to remember to take their PrEP or is associated with missing PrEP doses,” explained Dr. Pagkas-Bather.

In adjusted models, YBSMM who reported moderate sleep disturbances cited having too many pills to take as the reason for missing or forgetting PrEP doses (adjusted odds ratio, 7.59; 95% confidence interval, 1.05-54.57), compared with peers who did not have sleep issues.

Depression was likewise an important factor. Participants who reported experiencing sleep disturbance all of the time and missing PrEP doses were also highly likely to be depressed (aOR, 11.30; 95% CI, 1.19-107.53).

“The PHQ-9 is a widely accepted measure looking at depression – and sleep as one symptom of depression,” explained Brooke Genkin Rogers, Ph.D., M.P.H., a research scientist and assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I. 

Dr. Rogers, who was not involved in the study, noted, “Sleep disturbance is a sign of poor physical or mental health, particularly in an otherwise younger, healthier population.” But Dr. Rogers also had questions about sleep duration (that is, too short or too long) and whether or not it also played a role in poor adherence, information that was not pursued within the study. 

“As a clinician, I see quite a few people who are young Black sexual minority men who are on PrEP, or on the converse side, people living with HIV and taking medications for HIV treatment. I would posit a guess that it’s not that people are necessarily sleeping too much, but there are other sorts of factors that interfere with being able to get 8 hours of sleep a night,” explained Dr. Pagkas-Bather.

They include structural issues like greater exposure to housing instability and neighborhood safety. 

However, Dr. Pagkas-Bather pointed to an even more critical factor influencing PrEP usage and adherence, one that she refers to as “Trickle Up HIV Care.”

“We can’t just come up with interventions, drugs, and studies and say, we have all of these options, anyone who wants them, come and get them,” she said. “We really need to work very hard at educating and encouraging populations who have no high-level need for prevention and treatment.”

As a clinician who works closely with the YBSMM population, Dr. Pagkas-Bather also shared that her patients have told her that they’ve asked for PrEP and have had providers turn them down because they weren’t comfortable prescribing PrEP or made assumptions about the kind of people who are on PrEP. 

“There are sometimes assumptions made about Black men and sexual promiscuity. And the data doesn’t bear that out. It’s not that Black men are having more sex than White men or any other man; it’s that the prevalence of HIV in the Black community is higher overall relative to the population,” noted Dr. Pagkas-Bather.

“We need a nuanced approach to examining these issues ... to take a look at multiple levels of influence on folks’ health and HIV risk,” said Dr. Rogers.

Both clinicians acknowledged that creative solutions have not been exhausted. 

“There’s a lot of opportunity if we sit down with communities and share in decisions around HIV treatment and prevention ... if we tap into the wealth and knowledge of the Black communities to prevent HIV,” concluded Dr. Pagkas-Bather.

Dr. Pagkas-Bather reports that she is a Gilead Sciences HIV Research Scholar awardee. Dr. Rogers reports receiving a scientific research grant from Gilead Sciences. 

A version of this article first appeared on Medscape.com.

Among an estimated 87% of people with HIV (PWH) whose condition has been diagnosed, roughly 66% have received medication. But only half are retained in care, leaving substantial risk for viral rebound and further HIV transmission.

A variety of factors contribute to falling out of care (OOC), a primary reason why a team from the Centers for Disease Control and Prevention reviewed over three decades of studies with the goal of identifying best practices for re-engagement.

The research, which was published  in the journal AIDS, underscores the need for more customized strategies, rather than a one-size-fits-all approach, especially for historically underserved communities.

“Many study participants across the studies included in this review represented communities who have the largest challenges with remaining in care,” Darrel H. Higa, PhD, MSW, lead study author and a behavioral scientist at the CDC in Atlanta, told this news organization.

For example, “Some face barriers that may limit their access to care ... including not having health insurance or being unable to pay for doctor visits or medication, HIV-related stigma, racism, homophobia, transphobia, health literacy, and a lack of providers who specialize in HIV care,” he said.

Other challenges relate to personal barriers, such as competing priorities (for example, work or childcare), substance use, mental health disorders, transportation problems, or a lack of social support.

Even with improvements that address some of these barriers, such as expanded access to health care insurance and broader provision of medical care and HIV medications through the national Ryan White program, structural challenges and social barriers persist.
 

Better versus best practices

In their analysis, the CDC team expanded the scope of prior reviews by including literature published between 2000 and 2020 and further conducted meta-analyses to assess the effectiveness of five common, non mutually exclusive interventions:

• patient navigation
• appointment help/alerts
• psychosocial support
• transportation/appointment reminders
• data-to-care HIV care outcomes (using health department surveillance data and/or patient health records to identify and re-engage OOC PWH)

The majority of the 26,154 participants in 39 included studies (incorporating 42 unique interventions) were male (71%) and Black (64%); the most common time frame for OOC was between 6 and 12 months, but some studies used a time frame of 3-4 months, and others more than 12 months.

Definitions for re-engagement and retention were likewise inconsistent across studies but most commonly involved having an HIV medical visit or viral load test record between 2 and 6 months (re-engagement), and ≥ 1 medical visits in each 6-month period a minimum of 60 days apart for a period of over 2 years (retention).

This is notable, as it points to the role played – at least in part – by the care fragmentation inherent in the United States health care system. Without national indicators or thresholds for clinical outcomes, services are unlikely to reach scale.

“You can’t expect retention in care until you have a close to seamless, less fragmented safety net in the United States,” said Mary Jane Rotheram-Borus, PhD, distinguished professor of clinical psychology and director of the Global Center for Children and Families at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. (Dr. Rotheram-Borus authored an accompanying editorial but was not involved in the study.)

Nevertheless, review findings highlighted that overall, the five interventions appeared to improve care re-engagement (odds ratio = 1.79, 95% confidence interval, 1.36-2.36), care retention (OR = 2.01; 95% CI, 1.64-2.46), and viral suppression (OR = 2.50; 95% CI, 1.87-2.24).

Overall, the five strategies were associated with optimal re-engagement and retention in care. In addition, four of them were associated with viral suppression for PWH who were OOC during the study time frame. The one exception was data-to-care, for which the evidence supporting an association with viral suppression was unclear.

Because of the similarities between patient navigation and transportation/appointment accompaniment, the researchers also compared PWH who received combined strategies to those who did not.

“The findings suggest that patient navigation services that often include helping with transportation to appointments or accompanying PWH to appointments may be more effective compared to interventions without the combination,” explained Dr. Higa, “especially for communities with the largest challenges remaining in care.”

He added that, moving forward, many of the same strategies that help re-engage out-of-care PWH may be useful for retention. These include co-locating services, outreach, mental health services, clinical care models, telemedicine, and financial incentives.

Despite its financial investments toward ending the HIV epidemic, the United States arguably still has a long way to go to improve retention and care.

Still, Dr. Rotheram-Borus underscores the silver lining.

“The breakthroughs in medication are substantial,” she said, pointing to her own research, which has shown that at least 60% of newly infected, poor, LGBTQ+ young people up to age 24 have been linked to care and are adherent enough to be virally suppressed.

For PWH who are out of care, perhaps treatment advances – including long-acting injectables – may ultimately fill in the gaps.

Dr. Higa and Dr. Rotherum-Borus report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among an estimated 87% of people with HIV (PWH) whose condition has been diagnosed, roughly 66% have received medication. But only half are retained in care, leaving substantial risk for viral rebound and further HIV transmission.

A variety of factors contribute to falling out of care (OOC), a primary reason why a team from the Centers for Disease Control and Prevention reviewed over three decades of studies with the goal of identifying best practices for re-engagement.

The research, which was published  in the journal AIDS, underscores the need for more customized strategies, rather than a one-size-fits-all approach, especially for historically underserved communities.

“Many study participants across the studies included in this review represented communities who have the largest challenges with remaining in care,” Darrel H. Higa, PhD, MSW, lead study author and a behavioral scientist at the CDC in Atlanta, told this news organization.

For example, “Some face barriers that may limit their access to care ... including not having health insurance or being unable to pay for doctor visits or medication, HIV-related stigma, racism, homophobia, transphobia, health literacy, and a lack of providers who specialize in HIV care,” he said.

Other challenges relate to personal barriers, such as competing priorities (for example, work or childcare), substance use, mental health disorders, transportation problems, or a lack of social support.

Even with improvements that address some of these barriers, such as expanded access to health care insurance and broader provision of medical care and HIV medications through the national Ryan White program, structural challenges and social barriers persist.
 

Better versus best practices

In their analysis, the CDC team expanded the scope of prior reviews by including literature published between 2000 and 2020 and further conducted meta-analyses to assess the effectiveness of five common, non mutually exclusive interventions:

• patient navigation
• appointment help/alerts
• psychosocial support
• transportation/appointment reminders
• data-to-care HIV care outcomes (using health department surveillance data and/or patient health records to identify and re-engage OOC PWH)

The majority of the 26,154 participants in 39 included studies (incorporating 42 unique interventions) were male (71%) and Black (64%); the most common time frame for OOC was between 6 and 12 months, but some studies used a time frame of 3-4 months, and others more than 12 months.

Definitions for re-engagement and retention were likewise inconsistent across studies but most commonly involved having an HIV medical visit or viral load test record between 2 and 6 months (re-engagement), and ≥ 1 medical visits in each 6-month period a minimum of 60 days apart for a period of over 2 years (retention).

This is notable, as it points to the role played – at least in part – by the care fragmentation inherent in the United States health care system. Without national indicators or thresholds for clinical outcomes, services are unlikely to reach scale.

“You can’t expect retention in care until you have a close to seamless, less fragmented safety net in the United States,” said Mary Jane Rotheram-Borus, PhD, distinguished professor of clinical psychology and director of the Global Center for Children and Families at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. (Dr. Rotheram-Borus authored an accompanying editorial but was not involved in the study.)

Nevertheless, review findings highlighted that overall, the five interventions appeared to improve care re-engagement (odds ratio = 1.79, 95% confidence interval, 1.36-2.36), care retention (OR = 2.01; 95% CI, 1.64-2.46), and viral suppression (OR = 2.50; 95% CI, 1.87-2.24).

Overall, the five strategies were associated with optimal re-engagement and retention in care. In addition, four of them were associated with viral suppression for PWH who were OOC during the study time frame. The one exception was data-to-care, for which the evidence supporting an association with viral suppression was unclear.

Because of the similarities between patient navigation and transportation/appointment accompaniment, the researchers also compared PWH who received combined strategies to those who did not.

“The findings suggest that patient navigation services that often include helping with transportation to appointments or accompanying PWH to appointments may be more effective compared to interventions without the combination,” explained Dr. Higa, “especially for communities with the largest challenges remaining in care.”

He added that, moving forward, many of the same strategies that help re-engage out-of-care PWH may be useful for retention. These include co-locating services, outreach, mental health services, clinical care models, telemedicine, and financial incentives.

Despite its financial investments toward ending the HIV epidemic, the United States arguably still has a long way to go to improve retention and care.

Still, Dr. Rotheram-Borus underscores the silver lining.

“The breakthroughs in medication are substantial,” she said, pointing to her own research, which has shown that at least 60% of newly infected, poor, LGBTQ+ young people up to age 24 have been linked to care and are adherent enough to be virally suppressed.

For PWH who are out of care, perhaps treatment advances – including long-acting injectables – may ultimately fill in the gaps.

Dr. Higa and Dr. Rotherum-Borus report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among an estimated 87% of people with HIV (PWH) whose condition has been diagnosed, roughly 66% have received medication. But only half are retained in care, leaving substantial risk for viral rebound and further HIV transmission.

A variety of factors contribute to falling out of care (OOC), a primary reason why a team from the Centers for Disease Control and Prevention reviewed over three decades of studies with the goal of identifying best practices for re-engagement.

The research, which was published  in the journal AIDS, underscores the need for more customized strategies, rather than a one-size-fits-all approach, especially for historically underserved communities.

“Many study participants across the studies included in this review represented communities who have the largest challenges with remaining in care,” Darrel H. Higa, PhD, MSW, lead study author and a behavioral scientist at the CDC in Atlanta, told this news organization.

For example, “Some face barriers that may limit their access to care ... including not having health insurance or being unable to pay for doctor visits or medication, HIV-related stigma, racism, homophobia, transphobia, health literacy, and a lack of providers who specialize in HIV care,” he said.

Other challenges relate to personal barriers, such as competing priorities (for example, work or childcare), substance use, mental health disorders, transportation problems, or a lack of social support.

Even with improvements that address some of these barriers, such as expanded access to health care insurance and broader provision of medical care and HIV medications through the national Ryan White program, structural challenges and social barriers persist.
 

Better versus best practices

In their analysis, the CDC team expanded the scope of prior reviews by including literature published between 2000 and 2020 and further conducted meta-analyses to assess the effectiveness of five common, non mutually exclusive interventions:

• patient navigation
• appointment help/alerts
• psychosocial support
• transportation/appointment reminders
• data-to-care HIV care outcomes (using health department surveillance data and/or patient health records to identify and re-engage OOC PWH)

The majority of the 26,154 participants in 39 included studies (incorporating 42 unique interventions) were male (71%) and Black (64%); the most common time frame for OOC was between 6 and 12 months, but some studies used a time frame of 3-4 months, and others more than 12 months.

Definitions for re-engagement and retention were likewise inconsistent across studies but most commonly involved having an HIV medical visit or viral load test record between 2 and 6 months (re-engagement), and ≥ 1 medical visits in each 6-month period a minimum of 60 days apart for a period of over 2 years (retention).

This is notable, as it points to the role played – at least in part – by the care fragmentation inherent in the United States health care system. Without national indicators or thresholds for clinical outcomes, services are unlikely to reach scale.

“You can’t expect retention in care until you have a close to seamless, less fragmented safety net in the United States,” said Mary Jane Rotheram-Borus, PhD, distinguished professor of clinical psychology and director of the Global Center for Children and Families at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. (Dr. Rotheram-Borus authored an accompanying editorial but was not involved in the study.)

Nevertheless, review findings highlighted that overall, the five interventions appeared to improve care re-engagement (odds ratio = 1.79, 95% confidence interval, 1.36-2.36), care retention (OR = 2.01; 95% CI, 1.64-2.46), and viral suppression (OR = 2.50; 95% CI, 1.87-2.24).

Overall, the five strategies were associated with optimal re-engagement and retention in care. In addition, four of them were associated with viral suppression for PWH who were OOC during the study time frame. The one exception was data-to-care, for which the evidence supporting an association with viral suppression was unclear.

Because of the similarities between patient navigation and transportation/appointment accompaniment, the researchers also compared PWH who received combined strategies to those who did not.

“The findings suggest that patient navigation services that often include helping with transportation to appointments or accompanying PWH to appointments may be more effective compared to interventions without the combination,” explained Dr. Higa, “especially for communities with the largest challenges remaining in care.”

He added that, moving forward, many of the same strategies that help re-engage out-of-care PWH may be useful for retention. These include co-locating services, outreach, mental health services, clinical care models, telemedicine, and financial incentives.

Despite its financial investments toward ending the HIV epidemic, the United States arguably still has a long way to go to improve retention and care.

Still, Dr. Rotheram-Borus underscores the silver lining.

“The breakthroughs in medication are substantial,” she said, pointing to her own research, which has shown that at least 60% of newly infected, poor, LGBTQ+ young people up to age 24 have been linked to care and are adherent enough to be virally suppressed.

For PWH who are out of care, perhaps treatment advances – including long-acting injectables – may ultimately fill in the gaps.

Dr. Higa and Dr. Rotherum-Borus report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Good solutions have great road maps. 

For HIV preexposure prophylaxis (PrEP), the road map might just be that of contraceptive care. Once an onerous process, over time contraceptive care exploded into a range of options across a broad landscape in terms of approach and accessibility.

How then do organizations help vulnerable patients navigate their PrEP journeys using the contraceptive road map as a guide?

That’s what researchers at the University of Washington were intent on demonstrating, according to Julie Dombrowski, MD, MPH, an infectious disease specialist at the University of Washington, Seattle, and deputy director of the HIV/STD Program, Public Health for the city of Seattle and King County, Wash.

“The same sorts of things that happened with oral contraceptive pills – which initially required you to see a gynecologist and get a Pap smear – over time, became much more available,” said Dr. Dombrowski, coauthor of a new study published online in the Journal of Acquired Immune Deficiency Syndrome.

“The basic idea is that PrEP is not medically complicated; it can be easily protocolized,” she told this news organization.
 

Decentralizing HIV PrEP

In addition to her responsibilities at University of Washington, Dr. Dombrowski provides clinical services at the Public Health Sexual Health Clinic (PHSKC) at Seattle’s Harborview Medical Center – a dual-county center that provides confidential STI and HIV evaluation, screening, testing, and treatment on a walk-in basis for a sliding fee.

Sexual health clinics are ideal environments for reaching large numbers of patients, but strategies for integrating PrEP successfully into what are commonly one-time appointments have not been well-described or broadly adopted. 

“Sexual health clinics in general are STD specialty clinics with walk-in access to care; often, patients come into a clinic, get seen, diagnosed, and treated, and they don’t necessarily come back,” said Dr. Dombrowski. 

She said that, because most operations have been set up around same-day treatment, to offer PrEP and successfully change outcomes, there needs to be a shift in the current model toward one that promotes an ongoing relationship with the patients.

So, she and her colleagues decided to see what would happen if they implemented a decentralized PrEP model in their clinic over a 6-year period. They established a protocol that moves from an initial consultation with a clinician to review risk behaviors, ascertain HIV status, and acquire a PrEP prescription, to ongoing interactions with an STI and PrEP-trained disease intervention specialist (DIS).

As the clinic’s PrEP program coordinators, these specialists enroll patients in PrEP drug assistance programs, verify prescription fills, provide follow-up visits and adherence and adverse events assessments, and collect specimens.

“[Disease intervention specialists] are frontline public health workers who ensure that people diagnosed with HIV or an STI – or who’ve been exposed – get necessary testing and treatment,” explained Dr. Dombrowski. “They’re very similar to patient navigators.”

At the same time, clinicians remain the key providers for annual appointments, new symptoms, STI diagnoses, adverse drug reactions, and missed doses. Licensed medical providers review all labs.
 

Shifting responsibilities, better PrEP initiation, retention rates

After establishing the PrEP services protocol, the University of Washington team then assessed retention rates among PrEP patients who attended an initial visit (1,387) from October 2014 to December 2019. Follow-up continued through February 2020. (For study purposes, PrEP discontinuation was defined as either stopping PrEP after initiation or as lost to follow-up, i.e., either not attending a follow-up visit or not responding to more than three DIS calls or text messages).

Just over half of the participants were aged 20-29 years, and a third were aged 30-39. More than 9 out of 10 (93%) were men who sleep with men (MSM), 55% White, 26% Hispanic/Latinx, and 10% Black. 

Over the course of the study, 6,887 PrEP visits were recorded. Quarterly visits increased concurrently with the program expansion, from 31 visits in 2014 to 623 in the fourth quarter (Q4) of 2019. Likewise, while 57% of visits overall were with a clinician, DIS visits increased from 3% in Q4 of 2014 to 45% in Q4 of 2019, an increase of 1,400% in 5 years.

Significant numbers of patients also initiated PrEP in the clinic, especially when prescribing practices were expanded to be part of routine, walk-in visits.

Retention rates also improved, with 43% (510/1,190) of patients still on PrEP at the end of the analysis period. Forty-one percent (490) discontinued PrEP, 21% within 3 months of initiation, and 72% within a year; another 16% moved, transferred care, or tested positive, and were considered “censored.” However, as of July 31, 2021, 54% (265) of the 490 patients who had discontinued PrEP returned to the clinic for a restart visit, 93% of whom refilled their restart prescription.

“This is really basic preventative care and is actually quite easy to do,” noted Sarah Schmalzle, MD, assistant professor of medicine and medical director of the Thrive Program at the Institute of Human Virology at the University of Maryland, Baltimore. Dr. Schmalzle was not involved in the study. 

Dr. Schmalzle practices in inner-city Baltimore, so she and her colleagues have been thorough in terms of setting up PrEP (and postexposure prophylaxis, PEP) programs to ensure that patients access PrEP wherever they want to. But she also said that PrEP is only a part of the sexual wellness and prevention toolbox, and ideally, part of a whole prevention program. 

“Focusing on how to get the prescription out is great but the rest is having ongoing and accurate sexual health conversations, healthy conversations about sex and prevention, to have [an] algorithm in place that says, ‘Here’s your PrEP, this is the next time that you need an appointment, the next time you need labs, I’m going to check your adherence, etc.’ ”

Both Dr. Dombrowski and Dr. Schmalzle emphasized that decentralization is not a one-size model; flexibility is key, especially when it comes to who is providing PrEP 

“People overcomplicate PrEP and clinicians do this too,” said Dr. Dombrowski. “If we are going to successfully increase PrEP and improve the patient experience, we need to decrease the requirement for clinician involvement.”

Dr. Dombrowski has disclosed no relevant financial relationships. Dr. Schmalzle receives grant funding from Gilead Sciences.

A version of this article first appeared on Medscape.com.

Good solutions have great road maps. 

For HIV preexposure prophylaxis (PrEP), the road map might just be that of contraceptive care. Once an onerous process, over time contraceptive care exploded into a range of options across a broad landscape in terms of approach and accessibility.

How then do organizations help vulnerable patients navigate their PrEP journeys using the contraceptive road map as a guide?

That’s what researchers at the University of Washington were intent on demonstrating, according to Julie Dombrowski, MD, MPH, an infectious disease specialist at the University of Washington, Seattle, and deputy director of the HIV/STD Program, Public Health for the city of Seattle and King County, Wash.

“The same sorts of things that happened with oral contraceptive pills – which initially required you to see a gynecologist and get a Pap smear – over time, became much more available,” said Dr. Dombrowski, coauthor of a new study published online in the Journal of Acquired Immune Deficiency Syndrome.

“The basic idea is that PrEP is not medically complicated; it can be easily protocolized,” she told this news organization.
 

Decentralizing HIV PrEP

In addition to her responsibilities at University of Washington, Dr. Dombrowski provides clinical services at the Public Health Sexual Health Clinic (PHSKC) at Seattle’s Harborview Medical Center – a dual-county center that provides confidential STI and HIV evaluation, screening, testing, and treatment on a walk-in basis for a sliding fee.

Sexual health clinics are ideal environments for reaching large numbers of patients, but strategies for integrating PrEP successfully into what are commonly one-time appointments have not been well-described or broadly adopted. 

“Sexual health clinics in general are STD specialty clinics with walk-in access to care; often, patients come into a clinic, get seen, diagnosed, and treated, and they don’t necessarily come back,” said Dr. Dombrowski. 

She said that, because most operations have been set up around same-day treatment, to offer PrEP and successfully change outcomes, there needs to be a shift in the current model toward one that promotes an ongoing relationship with the patients.

So, she and her colleagues decided to see what would happen if they implemented a decentralized PrEP model in their clinic over a 6-year period. They established a protocol that moves from an initial consultation with a clinician to review risk behaviors, ascertain HIV status, and acquire a PrEP prescription, to ongoing interactions with an STI and PrEP-trained disease intervention specialist (DIS).

As the clinic’s PrEP program coordinators, these specialists enroll patients in PrEP drug assistance programs, verify prescription fills, provide follow-up visits and adherence and adverse events assessments, and collect specimens.

“[Disease intervention specialists] are frontline public health workers who ensure that people diagnosed with HIV or an STI – or who’ve been exposed – get necessary testing and treatment,” explained Dr. Dombrowski. “They’re very similar to patient navigators.”

At the same time, clinicians remain the key providers for annual appointments, new symptoms, STI diagnoses, adverse drug reactions, and missed doses. Licensed medical providers review all labs.
 

Shifting responsibilities, better PrEP initiation, retention rates

After establishing the PrEP services protocol, the University of Washington team then assessed retention rates among PrEP patients who attended an initial visit (1,387) from October 2014 to December 2019. Follow-up continued through February 2020. (For study purposes, PrEP discontinuation was defined as either stopping PrEP after initiation or as lost to follow-up, i.e., either not attending a follow-up visit or not responding to more than three DIS calls or text messages).

Just over half of the participants were aged 20-29 years, and a third were aged 30-39. More than 9 out of 10 (93%) were men who sleep with men (MSM), 55% White, 26% Hispanic/Latinx, and 10% Black. 

Over the course of the study, 6,887 PrEP visits were recorded. Quarterly visits increased concurrently with the program expansion, from 31 visits in 2014 to 623 in the fourth quarter (Q4) of 2019. Likewise, while 57% of visits overall were with a clinician, DIS visits increased from 3% in Q4 of 2014 to 45% in Q4 of 2019, an increase of 1,400% in 5 years.

Significant numbers of patients also initiated PrEP in the clinic, especially when prescribing practices were expanded to be part of routine, walk-in visits.

Retention rates also improved, with 43% (510/1,190) of patients still on PrEP at the end of the analysis period. Forty-one percent (490) discontinued PrEP, 21% within 3 months of initiation, and 72% within a year; another 16% moved, transferred care, or tested positive, and were considered “censored.” However, as of July 31, 2021, 54% (265) of the 490 patients who had discontinued PrEP returned to the clinic for a restart visit, 93% of whom refilled their restart prescription.

“This is really basic preventative care and is actually quite easy to do,” noted Sarah Schmalzle, MD, assistant professor of medicine and medical director of the Thrive Program at the Institute of Human Virology at the University of Maryland, Baltimore. Dr. Schmalzle was not involved in the study. 

Dr. Schmalzle practices in inner-city Baltimore, so she and her colleagues have been thorough in terms of setting up PrEP (and postexposure prophylaxis, PEP) programs to ensure that patients access PrEP wherever they want to. But she also said that PrEP is only a part of the sexual wellness and prevention toolbox, and ideally, part of a whole prevention program. 

“Focusing on how to get the prescription out is great but the rest is having ongoing and accurate sexual health conversations, healthy conversations about sex and prevention, to have [an] algorithm in place that says, ‘Here’s your PrEP, this is the next time that you need an appointment, the next time you need labs, I’m going to check your adherence, etc.’ ”

Both Dr. Dombrowski and Dr. Schmalzle emphasized that decentralization is not a one-size model; flexibility is key, especially when it comes to who is providing PrEP 

“People overcomplicate PrEP and clinicians do this too,” said Dr. Dombrowski. “If we are going to successfully increase PrEP and improve the patient experience, we need to decrease the requirement for clinician involvement.”

Dr. Dombrowski has disclosed no relevant financial relationships. Dr. Schmalzle receives grant funding from Gilead Sciences.

A version of this article first appeared on Medscape.com.

Good solutions have great road maps. 

For HIV preexposure prophylaxis (PrEP), the road map might just be that of contraceptive care. Once an onerous process, over time contraceptive care exploded into a range of options across a broad landscape in terms of approach and accessibility.

How then do organizations help vulnerable patients navigate their PrEP journeys using the contraceptive road map as a guide?

That’s what researchers at the University of Washington were intent on demonstrating, according to Julie Dombrowski, MD, MPH, an infectious disease specialist at the University of Washington, Seattle, and deputy director of the HIV/STD Program, Public Health for the city of Seattle and King County, Wash.

“The same sorts of things that happened with oral contraceptive pills – which initially required you to see a gynecologist and get a Pap smear – over time, became much more available,” said Dr. Dombrowski, coauthor of a new study published online in the Journal of Acquired Immune Deficiency Syndrome.

“The basic idea is that PrEP is not medically complicated; it can be easily protocolized,” she told this news organization.
 

Decentralizing HIV PrEP

In addition to her responsibilities at University of Washington, Dr. Dombrowski provides clinical services at the Public Health Sexual Health Clinic (PHSKC) at Seattle’s Harborview Medical Center – a dual-county center that provides confidential STI and HIV evaluation, screening, testing, and treatment on a walk-in basis for a sliding fee.

Sexual health clinics are ideal environments for reaching large numbers of patients, but strategies for integrating PrEP successfully into what are commonly one-time appointments have not been well-described or broadly adopted. 

“Sexual health clinics in general are STD specialty clinics with walk-in access to care; often, patients come into a clinic, get seen, diagnosed, and treated, and they don’t necessarily come back,” said Dr. Dombrowski. 

She said that, because most operations have been set up around same-day treatment, to offer PrEP and successfully change outcomes, there needs to be a shift in the current model toward one that promotes an ongoing relationship with the patients.

So, she and her colleagues decided to see what would happen if they implemented a decentralized PrEP model in their clinic over a 6-year period. They established a protocol that moves from an initial consultation with a clinician to review risk behaviors, ascertain HIV status, and acquire a PrEP prescription, to ongoing interactions with an STI and PrEP-trained disease intervention specialist (DIS).

As the clinic’s PrEP program coordinators, these specialists enroll patients in PrEP drug assistance programs, verify prescription fills, provide follow-up visits and adherence and adverse events assessments, and collect specimens.

“[Disease intervention specialists] are frontline public health workers who ensure that people diagnosed with HIV or an STI – or who’ve been exposed – get necessary testing and treatment,” explained Dr. Dombrowski. “They’re very similar to patient navigators.”

At the same time, clinicians remain the key providers for annual appointments, new symptoms, STI diagnoses, adverse drug reactions, and missed doses. Licensed medical providers review all labs.
 

Shifting responsibilities, better PrEP initiation, retention rates

After establishing the PrEP services protocol, the University of Washington team then assessed retention rates among PrEP patients who attended an initial visit (1,387) from October 2014 to December 2019. Follow-up continued through February 2020. (For study purposes, PrEP discontinuation was defined as either stopping PrEP after initiation or as lost to follow-up, i.e., either not attending a follow-up visit or not responding to more than three DIS calls or text messages).

Just over half of the participants were aged 20-29 years, and a third were aged 30-39. More than 9 out of 10 (93%) were men who sleep with men (MSM), 55% White, 26% Hispanic/Latinx, and 10% Black. 

Over the course of the study, 6,887 PrEP visits were recorded. Quarterly visits increased concurrently with the program expansion, from 31 visits in 2014 to 623 in the fourth quarter (Q4) of 2019. Likewise, while 57% of visits overall were with a clinician, DIS visits increased from 3% in Q4 of 2014 to 45% in Q4 of 2019, an increase of 1,400% in 5 years.

Significant numbers of patients also initiated PrEP in the clinic, especially when prescribing practices were expanded to be part of routine, walk-in visits.

Retention rates also improved, with 43% (510/1,190) of patients still on PrEP at the end of the analysis period. Forty-one percent (490) discontinued PrEP, 21% within 3 months of initiation, and 72% within a year; another 16% moved, transferred care, or tested positive, and were considered “censored.” However, as of July 31, 2021, 54% (265) of the 490 patients who had discontinued PrEP returned to the clinic for a restart visit, 93% of whom refilled their restart prescription.

“This is really basic preventative care and is actually quite easy to do,” noted Sarah Schmalzle, MD, assistant professor of medicine and medical director of the Thrive Program at the Institute of Human Virology at the University of Maryland, Baltimore. Dr. Schmalzle was not involved in the study. 

Dr. Schmalzle practices in inner-city Baltimore, so she and her colleagues have been thorough in terms of setting up PrEP (and postexposure prophylaxis, PEP) programs to ensure that patients access PrEP wherever they want to. But she also said that PrEP is only a part of the sexual wellness and prevention toolbox, and ideally, part of a whole prevention program. 

“Focusing on how to get the prescription out is great but the rest is having ongoing and accurate sexual health conversations, healthy conversations about sex and prevention, to have [an] algorithm in place that says, ‘Here’s your PrEP, this is the next time that you need an appointment, the next time you need labs, I’m going to check your adherence, etc.’ ”

Both Dr. Dombrowski and Dr. Schmalzle emphasized that decentralization is not a one-size model; flexibility is key, especially when it comes to who is providing PrEP 

“People overcomplicate PrEP and clinicians do this too,” said Dr. Dombrowski. “If we are going to successfully increase PrEP and improve the patient experience, we need to decrease the requirement for clinician involvement.”

Dr. Dombrowski has disclosed no relevant financial relationships. Dr. Schmalzle receives grant funding from Gilead Sciences.

A version of this article first appeared on Medscape.com.

Since the start of the pandemic, supply-chain problems have permeated just about every industry sector. While most of the media attention has focused on toilet paper and retail shipment delays, a darker, more sinister supply chain disruption has been unfolding, one that entails a sophisticated criminal enterprise that has been operating at scale to distribute and profit from counterfeit HIV drugs.

Recently, news has emerged – most notably in the Wall Street Journal – with reports of a Justice Department investigation into what appears to be a national drug trafficking network comprising more than 70 distributors and marketers.

The details read like a best-selling crime novel.

Since last year, authorities have seized 85,247 bottles of counterfeit HIV drugs, both Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Law enforcement has conducted raids at 17 locations in eight states. Doctored supply chain papers have provided cover for the fake medicines and the individuals behind them.

But unlike the inconvenience of sparse toilet paper, this crime poses life-threatening risks to millions of patients with HIV who rely on Biktarvy to suppress the virus or Descovy to prevent infection from it. Even worse, some patients have been exposed to over-the-counter painkillers or the antipsychotic drug quetiapine fumarate masquerading as HIV drugs in legitimate but repurposed bottles.

Gilead Sciences (Foster City, Calif.), which manufactures both Biktarvy and Descovy, declined to comment when contacted, instead referring this news organization to previous press statements.
 

Falsified HIV medications, illicit purchases over 2 Years

On Aug. 5, 2021, Gilead first warned the public that it had become aware of tampered and counterfeit Biktarvy and Descovy tablets. In coordination with the Food and Drug Administration, it alerted pharmacies to “investigate the potential for counterfeit or tampered Gilead medication sold by [unauthorized] distributors that may be within their recent supply.”

On Jan. 19, 2022, Gilead issued a second statement outlining ongoing actions in coordination with U.S. marshals and local law enforcement to remove these illegal medications from circulation and prevent further distribution.

The timing of the most recent announcement was not accidental. The day before, a federal judge serving the U.S. District Court for the Eastern District of New York unsealed documents detailing the company’s lawsuit against dozens of individuals and entities who they alleged had engaged in a highly coordinated effort to defraud pharmacies and consumers. The suit followed two prior Gilead filings that ultimately resulted in court-issued ex parte seizure orders (orders that allow a court to seize property without the property owner’s consent) and the recovery of more than 1,000 bottles containing questionable Gilead medications.

The lawsuit centered on Cambridge, Mass.–based wholesale pharmaceutical distributor Safe Chain Solutions and its two cofounders. The document is peppered with terms such as “shifting series of fly-by-night corporate entities,” “gray market” distributors, a “dedicated sales force,” and “shell entities,” along with accusations that the defendants were believed to have made purchases of gold bullion, jewelry, and other luxury items for conversion into cash.

In a curious twist of fate, this sinister effort appeared to have been first revealed not by a pharmacist but by a patient who had returned a bottle of Biktarvy with “foreign medication inside” to the California pharmacy that dispensed it.

“Specifically with HIV medications, there’s no point in which the pharmacy is actually opening the bottle, breaking the seal, and counting out pills to put into a smaller prescription bottle,” Emily Heil, PharmD, BCIDP, AAHIVP, associate professor of infectious diseases in the department of pharmacy practice and science at the University of Maryland School of Pharmacy, Baltimore, told this news organization.

“But that’s also why pharmacies work with these centralized groups of distributors that maintain a chain of command and fidelity with drug manufacturers so that we don’t run into these situations,” she said.

This is the link in the chain where that tightly coordinated and highly regulated process was broken.

Although Gilead and Safe Chain Solutions were informed of the incident as early as August 2020, the distributor repeatedly refused to identify the supplier and the pedigree (the record demonstrating the chain of all sales or transfers of a specific drug, going back to the manufacturer, as required by the FDA’s Drug Supply Chain Security Act in 2013).

Later that year, Janssen Pharmaceutical Companies of Johnson & Johnson issued a media statement saying that they had been alerted to the distribution of counterfeit Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to three pharmacies in the United States.

A spokesperson for the FDA declined to comment on the ongoing investigation when contacted by this news organization and instead wrote in an email that the agency “will continue to use all available tools to ensure consumers and patients have access to a safe and effective medical product supply.”
 

Old dog, new tricks

This is not the first time that HIV drugs have been targeted for criminal benefit. An analysis published in September 2014 in JAMA highlighted a federal investigation that year into a $32 million dollar scheme to defraud Medicare’s Part D program for HIV drugs and divert them for resale on the black market.

What’s more, prior research and news reports highlight the attractiveness of HIV drug diversion both for the buyer and the seller – not only because of the cost of the drugs themselves but also because of institutional or systemic deficiencies that exclude certain individuals from obtaining treatment through federal initiatives such as the Ryan White/AIDS Drug Assistance program.

In its most recent statement, Gilead reinforced that this practice remains alive and well.

On the buyer side, the company stated, many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was first dispensed to them. Unfortunately, the exploitation of individuals with low incomes who experience homelessness or substance use/abuse echoes a pattern whereby HIV patients sell medications to cover personal needs or are forced to buy them on the black market to keep up with their treatment regimens.

On the supply side, Gilead explained that individuals’ medications “are unlawfully resold ... on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead products.”

But counterfeit pedigrees make it impossible to verify where the products came from, how they have been handled and stored, and what pills are in the bottles – all of which can have dire consequences for patients who ingest them.

The ramifications can be devastating.

“With HIV meds specifically, the worst case scenario would be if the medication is not actually the medication they’re supposed to be on,” said Dr. Heil, reinforcing that the increased safety net provided with viral suppression and against transmission is lost.

Dr. Heil pointed to another significant risk: resistance.

“In a situation like this, where maybe it’s not the full strength of the medication, maybe it’s expired and lost potency or was not stored correctly or is not even the accurate medication, changing those drug level exposures potentially puts the patient at risk for developing resistance to their regimen without them knowing.”

Yet another risk was posed by the replacement of HIV drugs with other medications, such as quetiapine, which increased the risk for life-threatening and irreversible side effects. The lawsuit included a story of a patient who unknowingly took quetiapine after receiving a counterfeit bottle of Biktarvy and could not speak or walk afterward.

Where this tale will ultimately end is unclear. There’s no telling what other activities or bad actors the Justice Department investigation will uncover as it works to unravel the counterfeit network’s activities and deal with its aftermath.

Regardless, clinicians are encouraged to inform HIV patients about the risks associated with counterfeit medications, how to determine whether the drugs they’ve been dispensed are authentic, and to report any product they believe to be counterfeit or to have been tampered with to their doctors, pharmacies, and to Gilead or other drug manufacturers.

“It’s okay to ask questions of your pharmacy about where they get their medications from,” noted Dr. Heil. “If patients have access to an independent pharmacy, it’s a great way for them to have a relationship with their pharmacist.

“We went into this profession to be able to have those conversations with patients,” Dr. Heil said.

The FDA recommends that patients receiving these medications who believe that their drugs may be counterfeit or who experience any adverse effects report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch).

Dr. Heil reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Since the start of the pandemic, supply-chain problems have permeated just about every industry sector. While most of the media attention has focused on toilet paper and retail shipment delays, a darker, more sinister supply chain disruption has been unfolding, one that entails a sophisticated criminal enterprise that has been operating at scale to distribute and profit from counterfeit HIV drugs.

Recently, news has emerged – most notably in the Wall Street Journal – with reports of a Justice Department investigation into what appears to be a national drug trafficking network comprising more than 70 distributors and marketers.

The details read like a best-selling crime novel.

Since last year, authorities have seized 85,247 bottles of counterfeit HIV drugs, both Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Law enforcement has conducted raids at 17 locations in eight states. Doctored supply chain papers have provided cover for the fake medicines and the individuals behind them.

But unlike the inconvenience of sparse toilet paper, this crime poses life-threatening risks to millions of patients with HIV who rely on Biktarvy to suppress the virus or Descovy to prevent infection from it. Even worse, some patients have been exposed to over-the-counter painkillers or the antipsychotic drug quetiapine fumarate masquerading as HIV drugs in legitimate but repurposed bottles.

Gilead Sciences (Foster City, Calif.), which manufactures both Biktarvy and Descovy, declined to comment when contacted, instead referring this news organization to previous press statements.
 

Falsified HIV medications, illicit purchases over 2 Years

On Aug. 5, 2021, Gilead first warned the public that it had become aware of tampered and counterfeit Biktarvy and Descovy tablets. In coordination with the Food and Drug Administration, it alerted pharmacies to “investigate the potential for counterfeit or tampered Gilead medication sold by [unauthorized] distributors that may be within their recent supply.”

On Jan. 19, 2022, Gilead issued a second statement outlining ongoing actions in coordination with U.S. marshals and local law enforcement to remove these illegal medications from circulation and prevent further distribution.

The timing of the most recent announcement was not accidental. The day before, a federal judge serving the U.S. District Court for the Eastern District of New York unsealed documents detailing the company’s lawsuit against dozens of individuals and entities who they alleged had engaged in a highly coordinated effort to defraud pharmacies and consumers. The suit followed two prior Gilead filings that ultimately resulted in court-issued ex parte seizure orders (orders that allow a court to seize property without the property owner’s consent) and the recovery of more than 1,000 bottles containing questionable Gilead medications.

The lawsuit centered on Cambridge, Mass.–based wholesale pharmaceutical distributor Safe Chain Solutions and its two cofounders. The document is peppered with terms such as “shifting series of fly-by-night corporate entities,” “gray market” distributors, a “dedicated sales force,” and “shell entities,” along with accusations that the defendants were believed to have made purchases of gold bullion, jewelry, and other luxury items for conversion into cash.

In a curious twist of fate, this sinister effort appeared to have been first revealed not by a pharmacist but by a patient who had returned a bottle of Biktarvy with “foreign medication inside” to the California pharmacy that dispensed it.

“Specifically with HIV medications, there’s no point in which the pharmacy is actually opening the bottle, breaking the seal, and counting out pills to put into a smaller prescription bottle,” Emily Heil, PharmD, BCIDP, AAHIVP, associate professor of infectious diseases in the department of pharmacy practice and science at the University of Maryland School of Pharmacy, Baltimore, told this news organization.

“But that’s also why pharmacies work with these centralized groups of distributors that maintain a chain of command and fidelity with drug manufacturers so that we don’t run into these situations,” she said.

This is the link in the chain where that tightly coordinated and highly regulated process was broken.

Although Gilead and Safe Chain Solutions were informed of the incident as early as August 2020, the distributor repeatedly refused to identify the supplier and the pedigree (the record demonstrating the chain of all sales or transfers of a specific drug, going back to the manufacturer, as required by the FDA’s Drug Supply Chain Security Act in 2013).

Later that year, Janssen Pharmaceutical Companies of Johnson & Johnson issued a media statement saying that they had been alerted to the distribution of counterfeit Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to three pharmacies in the United States.

A spokesperson for the FDA declined to comment on the ongoing investigation when contacted by this news organization and instead wrote in an email that the agency “will continue to use all available tools to ensure consumers and patients have access to a safe and effective medical product supply.”
 

Old dog, new tricks

This is not the first time that HIV drugs have been targeted for criminal benefit. An analysis published in September 2014 in JAMA highlighted a federal investigation that year into a $32 million dollar scheme to defraud Medicare’s Part D program for HIV drugs and divert them for resale on the black market.

What’s more, prior research and news reports highlight the attractiveness of HIV drug diversion both for the buyer and the seller – not only because of the cost of the drugs themselves but also because of institutional or systemic deficiencies that exclude certain individuals from obtaining treatment through federal initiatives such as the Ryan White/AIDS Drug Assistance program.

In its most recent statement, Gilead reinforced that this practice remains alive and well.

On the buyer side, the company stated, many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was first dispensed to them. Unfortunately, the exploitation of individuals with low incomes who experience homelessness or substance use/abuse echoes a pattern whereby HIV patients sell medications to cover personal needs or are forced to buy them on the black market to keep up with their treatment regimens.

On the supply side, Gilead explained that individuals’ medications “are unlawfully resold ... on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead products.”

But counterfeit pedigrees make it impossible to verify where the products came from, how they have been handled and stored, and what pills are in the bottles – all of which can have dire consequences for patients who ingest them.

The ramifications can be devastating.

“With HIV meds specifically, the worst case scenario would be if the medication is not actually the medication they’re supposed to be on,” said Dr. Heil, reinforcing that the increased safety net provided with viral suppression and against transmission is lost.

Dr. Heil pointed to another significant risk: resistance.

“In a situation like this, where maybe it’s not the full strength of the medication, maybe it’s expired and lost potency or was not stored correctly or is not even the accurate medication, changing those drug level exposures potentially puts the patient at risk for developing resistance to their regimen without them knowing.”

Yet another risk was posed by the replacement of HIV drugs with other medications, such as quetiapine, which increased the risk for life-threatening and irreversible side effects. The lawsuit included a story of a patient who unknowingly took quetiapine after receiving a counterfeit bottle of Biktarvy and could not speak or walk afterward.

Where this tale will ultimately end is unclear. There’s no telling what other activities or bad actors the Justice Department investigation will uncover as it works to unravel the counterfeit network’s activities and deal with its aftermath.

Regardless, clinicians are encouraged to inform HIV patients about the risks associated with counterfeit medications, how to determine whether the drugs they’ve been dispensed are authentic, and to report any product they believe to be counterfeit or to have been tampered with to their doctors, pharmacies, and to Gilead or other drug manufacturers.

“It’s okay to ask questions of your pharmacy about where they get their medications from,” noted Dr. Heil. “If patients have access to an independent pharmacy, it’s a great way for them to have a relationship with their pharmacist.

“We went into this profession to be able to have those conversations with patients,” Dr. Heil said.

The FDA recommends that patients receiving these medications who believe that their drugs may be counterfeit or who experience any adverse effects report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch).

Dr. Heil reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Since the start of the pandemic, supply-chain problems have permeated just about every industry sector. While most of the media attention has focused on toilet paper and retail shipment delays, a darker, more sinister supply chain disruption has been unfolding, one that entails a sophisticated criminal enterprise that has been operating at scale to distribute and profit from counterfeit HIV drugs.

Recently, news has emerged – most notably in the Wall Street Journal – with reports of a Justice Department investigation into what appears to be a national drug trafficking network comprising more than 70 distributors and marketers.

The details read like a best-selling crime novel.

Since last year, authorities have seized 85,247 bottles of counterfeit HIV drugs, both Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Law enforcement has conducted raids at 17 locations in eight states. Doctored supply chain papers have provided cover for the fake medicines and the individuals behind them.

But unlike the inconvenience of sparse toilet paper, this crime poses life-threatening risks to millions of patients with HIV who rely on Biktarvy to suppress the virus or Descovy to prevent infection from it. Even worse, some patients have been exposed to over-the-counter painkillers or the antipsychotic drug quetiapine fumarate masquerading as HIV drugs in legitimate but repurposed bottles.

Gilead Sciences (Foster City, Calif.), which manufactures both Biktarvy and Descovy, declined to comment when contacted, instead referring this news organization to previous press statements.
 

Falsified HIV medications, illicit purchases over 2 Years

On Aug. 5, 2021, Gilead first warned the public that it had become aware of tampered and counterfeit Biktarvy and Descovy tablets. In coordination with the Food and Drug Administration, it alerted pharmacies to “investigate the potential for counterfeit or tampered Gilead medication sold by [unauthorized] distributors that may be within their recent supply.”

On Jan. 19, 2022, Gilead issued a second statement outlining ongoing actions in coordination with U.S. marshals and local law enforcement to remove these illegal medications from circulation and prevent further distribution.

The timing of the most recent announcement was not accidental. The day before, a federal judge serving the U.S. District Court for the Eastern District of New York unsealed documents detailing the company’s lawsuit against dozens of individuals and entities who they alleged had engaged in a highly coordinated effort to defraud pharmacies and consumers. The suit followed two prior Gilead filings that ultimately resulted in court-issued ex parte seizure orders (orders that allow a court to seize property without the property owner’s consent) and the recovery of more than 1,000 bottles containing questionable Gilead medications.

The lawsuit centered on Cambridge, Mass.–based wholesale pharmaceutical distributor Safe Chain Solutions and its two cofounders. The document is peppered with terms such as “shifting series of fly-by-night corporate entities,” “gray market” distributors, a “dedicated sales force,” and “shell entities,” along with accusations that the defendants were believed to have made purchases of gold bullion, jewelry, and other luxury items for conversion into cash.

In a curious twist of fate, this sinister effort appeared to have been first revealed not by a pharmacist but by a patient who had returned a bottle of Biktarvy with “foreign medication inside” to the California pharmacy that dispensed it.

“Specifically with HIV medications, there’s no point in which the pharmacy is actually opening the bottle, breaking the seal, and counting out pills to put into a smaller prescription bottle,” Emily Heil, PharmD, BCIDP, AAHIVP, associate professor of infectious diseases in the department of pharmacy practice and science at the University of Maryland School of Pharmacy, Baltimore, told this news organization.

“But that’s also why pharmacies work with these centralized groups of distributors that maintain a chain of command and fidelity with drug manufacturers so that we don’t run into these situations,” she said.

This is the link in the chain where that tightly coordinated and highly regulated process was broken.

Although Gilead and Safe Chain Solutions were informed of the incident as early as August 2020, the distributor repeatedly refused to identify the supplier and the pedigree (the record demonstrating the chain of all sales or transfers of a specific drug, going back to the manufacturer, as required by the FDA’s Drug Supply Chain Security Act in 2013).

Later that year, Janssen Pharmaceutical Companies of Johnson & Johnson issued a media statement saying that they had been alerted to the distribution of counterfeit Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to three pharmacies in the United States.

A spokesperson for the FDA declined to comment on the ongoing investigation when contacted by this news organization and instead wrote in an email that the agency “will continue to use all available tools to ensure consumers and patients have access to a safe and effective medical product supply.”
 

Old dog, new tricks

This is not the first time that HIV drugs have been targeted for criminal benefit. An analysis published in September 2014 in JAMA highlighted a federal investigation that year into a $32 million dollar scheme to defraud Medicare’s Part D program for HIV drugs and divert them for resale on the black market.

What’s more, prior research and news reports highlight the attractiveness of HIV drug diversion both for the buyer and the seller – not only because of the cost of the drugs themselves but also because of institutional or systemic deficiencies that exclude certain individuals from obtaining treatment through federal initiatives such as the Ryan White/AIDS Drug Assistance program.

In its most recent statement, Gilead reinforced that this practice remains alive and well.

On the buyer side, the company stated, many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was first dispensed to them. Unfortunately, the exploitation of individuals with low incomes who experience homelessness or substance use/abuse echoes a pattern whereby HIV patients sell medications to cover personal needs or are forced to buy them on the black market to keep up with their treatment regimens.

On the supply side, Gilead explained that individuals’ medications “are unlawfully resold ... on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead products.”

But counterfeit pedigrees make it impossible to verify where the products came from, how they have been handled and stored, and what pills are in the bottles – all of which can have dire consequences for patients who ingest them.

The ramifications can be devastating.

“With HIV meds specifically, the worst case scenario would be if the medication is not actually the medication they’re supposed to be on,” said Dr. Heil, reinforcing that the increased safety net provided with viral suppression and against transmission is lost.

Dr. Heil pointed to another significant risk: resistance.

“In a situation like this, where maybe it’s not the full strength of the medication, maybe it’s expired and lost potency or was not stored correctly or is not even the accurate medication, changing those drug level exposures potentially puts the patient at risk for developing resistance to their regimen without them knowing.”

Yet another risk was posed by the replacement of HIV drugs with other medications, such as quetiapine, which increased the risk for life-threatening and irreversible side effects. The lawsuit included a story of a patient who unknowingly took quetiapine after receiving a counterfeit bottle of Biktarvy and could not speak or walk afterward.

Where this tale will ultimately end is unclear. There’s no telling what other activities or bad actors the Justice Department investigation will uncover as it works to unravel the counterfeit network’s activities and deal with its aftermath.

Regardless, clinicians are encouraged to inform HIV patients about the risks associated with counterfeit medications, how to determine whether the drugs they’ve been dispensed are authentic, and to report any product they believe to be counterfeit or to have been tampered with to their doctors, pharmacies, and to Gilead or other drug manufacturers.

“It’s okay to ask questions of your pharmacy about where they get their medications from,” noted Dr. Heil. “If patients have access to an independent pharmacy, it’s a great way for them to have a relationship with their pharmacist.

“We went into this profession to be able to have those conversations with patients,” Dr. Heil said.

The FDA recommends that patients receiving these medications who believe that their drugs may be counterfeit or who experience any adverse effects report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch).

Dr. Heil reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Over the past decade, data have suggested that antiretroviral therapy (ART) may be associated with an increased risk for adverse pregnancy outcomes, namely, preterm birth (PTB). But a combination of methodologic challenges, demographic gaps, and spotty clinical data has left the question unresolved, especially for pregnant women with HIV who reside in developed countries.

“Given that a lot of the emerging data has come out of resource-limited settings where patient and clinical characteristics are different from developed world settings like the United States, we felt that this was an important question to address,” Kartik Venkatesh, MD, PhD, a high-risk obstetrician and perinatal epidemiologist at the Ohio State Wexner Medical Center, Columbus, told this news organization.

In a prospective cohort study of U.S. women with or at risk for HIV, Dr. Venkatesh and his colleagues found that ART exposure (including highly active antiretroviral therapy [HAART]) was associated with as much as an 80% decline in the likelihood of PTB (defined as birth less than 34 weeks). The study was published in HIV Medicine.
 

24 years of data analyzed

Dr. Venkatesh and his team analyzed self-reported birth data of women with singleton live-born pregnancies enrolled in the ongoing, multicenter, prospective observational Women’s Interagency HIV Study (WIHS) from Oct. 1, 1995, to March 31, 2019.

“We first looked at women with HIV versus without HIV, [who were] matched on many clinical and sociodemographic characteristics and at similarly high risk of some of these obstetrical outcomes like PTB,” explained Dr. Venkatesh. “We then looked at the relative impact of antiretroviral therapy amongst women living with HIV compared to no antiretroviral therapy.”

ART regimens were classified as none, monotherapy, dual therapy, or HAART. (HAART was defined as more than three antiretrovirals, including at least one protease inhibitor [PI], nonnucleoside reverse transcriptase inhibitor, integrase inhibitor, or entry inhibitor.) In this cohort, for 63.5% of women receiving ART, therapy was initiated before pregnancy (mean duration of HAART, 6 years), and most were virally suppressed.

Among the 4,944 women assessed in the WIHS trial, 74% (3,646) had HIV. In total, 383 women had 488 singleton deliveries, including 218 women with HIV (272 deliveries) and 165 without HIV (216 deliveries). Sociodemographics in both cohorts were well matched. For most participants, the mean age was 40-41 years at delivery, most were non-Hispanic Black persons, and the mean pregnancy body mass index was greater than or equal to 29 kg/m2. Of the women with HIV, 33% had chronic hypertension; of those without HIV, 42.1% had chronic hypertension; 4.7% and 5.0%, respectively, had pregestational diabetes.

The findings showed that PTB risk less than 34 weeks was similar between women with (10%) and without (8%) HIV (adjusted risk ratio, 1.30; 95% confidence interval, 0.74-2.31). Among deliveries to women with HIV who were receiving ART, PTB risk less than 34 weeks was lower with HAART (7%), compared with not receiving ART (26%) (aRR, 0.19), as well as with monotherapy or dual therapy (3% vs. no ART) (aRR, 0.12). Notably, 67% of deliveries to women receiving HAART included a PI-containing regimen, but these women were not significantly more likely to have a PTB less than 34 weeks, compared with women taking non-PI HAART regimens (aRR, 2.61; 95% CI, 0.65-10.59). Results were similar for secondary outcomes (PTB less than 28 weeks, less than 37 weeks).
 

Filling in the gaps toward the safest regimen

“This study spans 25 years, so it covers a lot of the history of HIV in pregnancy and is reassuring around using ART in pregnancy,” Shahin Lockman, MD, told this news organization. Dr. Lockman is an associate professor of infectious diseases at Brigham and Women’s Hospital and a co-PI of the Botswana Clinical Trials Unit at the Botswana Harvard AIDS Institute Partnership. She was not involved in the study. “One of the worst things for a mother and for pregnancy outcomes, for the fetus and baby’s health and development, is uncontrolled maternal HIV,’’ she said.

Dr. Lockman also noted potential confounders that drive poor birth outcomes in Southern African women, compared with U.S. women, making comparisons between this and other observational studies difficult. Still, she said that the question is not whether women should be receiving treatment but whether or not there are differences between antiretroviral regimens.

“One of the areas that we did not go deeper into was the subtype of antiretroviral therapy, given the relatively small study numbers [did not] allow us to do a robust analysis,” Dr. Venkatesh said.

Rather, he emphasized that the findings might lend more weight to speculation that immunologic characteristics associated with HIV status and immunotherapy – such as low CD4 cell counts prior to delivery, or duration of HIV infection – may be important drivers of adverse birth outcomes among women with HIV taking ART.

And at least in this cohort, many of these characteristics were similar between the treatment groups.

Both researchers agree that the findings – while reassuring – highlight the importance of collecting robust obstetric and safety data as part of prospective databases of individuals living with HIV, not only in resource-limited settings but also among the domestic U.S. population.

“We’ve learned a lot over the last 10 years,” Dr. Lockman said. “Some regimens (like lopinavir/ritonavir or nevirapine) are associated with significantly worse birth outcomes, whereas efavirenz doesn’t seem to be, or less so, and dolutegravir seems to be associated with even better outcomes. So, I think that where we are moving is to regimens that are the safest.”

Moving forward, Dr. Venkatesh explained, not only should researchers focus on exploring which antiretrovirals are safest in this context but also if the use of preexposure prophylaxis during conception periods affects birth outcomes.

Dr. Venkatesh and Dr. Lockman report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Over the past decade, data have suggested that antiretroviral therapy (ART) may be associated with an increased risk for adverse pregnancy outcomes, namely, preterm birth (PTB). But a combination of methodologic challenges, demographic gaps, and spotty clinical data has left the question unresolved, especially for pregnant women with HIV who reside in developed countries.

“Given that a lot of the emerging data has come out of resource-limited settings where patient and clinical characteristics are different from developed world settings like the United States, we felt that this was an important question to address,” Kartik Venkatesh, MD, PhD, a high-risk obstetrician and perinatal epidemiologist at the Ohio State Wexner Medical Center, Columbus, told this news organization.

In a prospective cohort study of U.S. women with or at risk for HIV, Dr. Venkatesh and his colleagues found that ART exposure (including highly active antiretroviral therapy [HAART]) was associated with as much as an 80% decline in the likelihood of PTB (defined as birth less than 34 weeks). The study was published in HIV Medicine.
 

24 years of data analyzed

Dr. Venkatesh and his team analyzed self-reported birth data of women with singleton live-born pregnancies enrolled in the ongoing, multicenter, prospective observational Women’s Interagency HIV Study (WIHS) from Oct. 1, 1995, to March 31, 2019.

“We first looked at women with HIV versus without HIV, [who were] matched on many clinical and sociodemographic characteristics and at similarly high risk of some of these obstetrical outcomes like PTB,” explained Dr. Venkatesh. “We then looked at the relative impact of antiretroviral therapy amongst women living with HIV compared to no antiretroviral therapy.”

ART regimens were classified as none, monotherapy, dual therapy, or HAART. (HAART was defined as more than three antiretrovirals, including at least one protease inhibitor [PI], nonnucleoside reverse transcriptase inhibitor, integrase inhibitor, or entry inhibitor.) In this cohort, for 63.5% of women receiving ART, therapy was initiated before pregnancy (mean duration of HAART, 6 years), and most were virally suppressed.

Among the 4,944 women assessed in the WIHS trial, 74% (3,646) had HIV. In total, 383 women had 488 singleton deliveries, including 218 women with HIV (272 deliveries) and 165 without HIV (216 deliveries). Sociodemographics in both cohorts were well matched. For most participants, the mean age was 40-41 years at delivery, most were non-Hispanic Black persons, and the mean pregnancy body mass index was greater than or equal to 29 kg/m2. Of the women with HIV, 33% had chronic hypertension; of those without HIV, 42.1% had chronic hypertension; 4.7% and 5.0%, respectively, had pregestational diabetes.

The findings showed that PTB risk less than 34 weeks was similar between women with (10%) and without (8%) HIV (adjusted risk ratio, 1.30; 95% confidence interval, 0.74-2.31). Among deliveries to women with HIV who were receiving ART, PTB risk less than 34 weeks was lower with HAART (7%), compared with not receiving ART (26%) (aRR, 0.19), as well as with monotherapy or dual therapy (3% vs. no ART) (aRR, 0.12). Notably, 67% of deliveries to women receiving HAART included a PI-containing regimen, but these women were not significantly more likely to have a PTB less than 34 weeks, compared with women taking non-PI HAART regimens (aRR, 2.61; 95% CI, 0.65-10.59). Results were similar for secondary outcomes (PTB less than 28 weeks, less than 37 weeks).
 

Filling in the gaps toward the safest regimen

“This study spans 25 years, so it covers a lot of the history of HIV in pregnancy and is reassuring around using ART in pregnancy,” Shahin Lockman, MD, told this news organization. Dr. Lockman is an associate professor of infectious diseases at Brigham and Women’s Hospital and a co-PI of the Botswana Clinical Trials Unit at the Botswana Harvard AIDS Institute Partnership. She was not involved in the study. “One of the worst things for a mother and for pregnancy outcomes, for the fetus and baby’s health and development, is uncontrolled maternal HIV,’’ she said.

Dr. Lockman also noted potential confounders that drive poor birth outcomes in Southern African women, compared with U.S. women, making comparisons between this and other observational studies difficult. Still, she said that the question is not whether women should be receiving treatment but whether or not there are differences between antiretroviral regimens.

“One of the areas that we did not go deeper into was the subtype of antiretroviral therapy, given the relatively small study numbers [did not] allow us to do a robust analysis,” Dr. Venkatesh said.

Rather, he emphasized that the findings might lend more weight to speculation that immunologic characteristics associated with HIV status and immunotherapy – such as low CD4 cell counts prior to delivery, or duration of HIV infection – may be important drivers of adverse birth outcomes among women with HIV taking ART.

And at least in this cohort, many of these characteristics were similar between the treatment groups.

Both researchers agree that the findings – while reassuring – highlight the importance of collecting robust obstetric and safety data as part of prospective databases of individuals living with HIV, not only in resource-limited settings but also among the domestic U.S. population.

“We’ve learned a lot over the last 10 years,” Dr. Lockman said. “Some regimens (like lopinavir/ritonavir or nevirapine) are associated with significantly worse birth outcomes, whereas efavirenz doesn’t seem to be, or less so, and dolutegravir seems to be associated with even better outcomes. So, I think that where we are moving is to regimens that are the safest.”

Moving forward, Dr. Venkatesh explained, not only should researchers focus on exploring which antiretrovirals are safest in this context but also if the use of preexposure prophylaxis during conception periods affects birth outcomes.

Dr. Venkatesh and Dr. Lockman report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Over the past decade, data have suggested that antiretroviral therapy (ART) may be associated with an increased risk for adverse pregnancy outcomes, namely, preterm birth (PTB). But a combination of methodologic challenges, demographic gaps, and spotty clinical data has left the question unresolved, especially for pregnant women with HIV who reside in developed countries.

“Given that a lot of the emerging data has come out of resource-limited settings where patient and clinical characteristics are different from developed world settings like the United States, we felt that this was an important question to address,” Kartik Venkatesh, MD, PhD, a high-risk obstetrician and perinatal epidemiologist at the Ohio State Wexner Medical Center, Columbus, told this news organization.

In a prospective cohort study of U.S. women with or at risk for HIV, Dr. Venkatesh and his colleagues found that ART exposure (including highly active antiretroviral therapy [HAART]) was associated with as much as an 80% decline in the likelihood of PTB (defined as birth less than 34 weeks). The study was published in HIV Medicine.
 

24 years of data analyzed

Dr. Venkatesh and his team analyzed self-reported birth data of women with singleton live-born pregnancies enrolled in the ongoing, multicenter, prospective observational Women’s Interagency HIV Study (WIHS) from Oct. 1, 1995, to March 31, 2019.

“We first looked at women with HIV versus without HIV, [who were] matched on many clinical and sociodemographic characteristics and at similarly high risk of some of these obstetrical outcomes like PTB,” explained Dr. Venkatesh. “We then looked at the relative impact of antiretroviral therapy amongst women living with HIV compared to no antiretroviral therapy.”

ART regimens were classified as none, monotherapy, dual therapy, or HAART. (HAART was defined as more than three antiretrovirals, including at least one protease inhibitor [PI], nonnucleoside reverse transcriptase inhibitor, integrase inhibitor, or entry inhibitor.) In this cohort, for 63.5% of women receiving ART, therapy was initiated before pregnancy (mean duration of HAART, 6 years), and most were virally suppressed.

Among the 4,944 women assessed in the WIHS trial, 74% (3,646) had HIV. In total, 383 women had 488 singleton deliveries, including 218 women with HIV (272 deliveries) and 165 without HIV (216 deliveries). Sociodemographics in both cohorts were well matched. For most participants, the mean age was 40-41 years at delivery, most were non-Hispanic Black persons, and the mean pregnancy body mass index was greater than or equal to 29 kg/m2. Of the women with HIV, 33% had chronic hypertension; of those without HIV, 42.1% had chronic hypertension; 4.7% and 5.0%, respectively, had pregestational diabetes.

The findings showed that PTB risk less than 34 weeks was similar between women with (10%) and without (8%) HIV (adjusted risk ratio, 1.30; 95% confidence interval, 0.74-2.31). Among deliveries to women with HIV who were receiving ART, PTB risk less than 34 weeks was lower with HAART (7%), compared with not receiving ART (26%) (aRR, 0.19), as well as with monotherapy or dual therapy (3% vs. no ART) (aRR, 0.12). Notably, 67% of deliveries to women receiving HAART included a PI-containing regimen, but these women were not significantly more likely to have a PTB less than 34 weeks, compared with women taking non-PI HAART regimens (aRR, 2.61; 95% CI, 0.65-10.59). Results were similar for secondary outcomes (PTB less than 28 weeks, less than 37 weeks).
 

Filling in the gaps toward the safest regimen

“This study spans 25 years, so it covers a lot of the history of HIV in pregnancy and is reassuring around using ART in pregnancy,” Shahin Lockman, MD, told this news organization. Dr. Lockman is an associate professor of infectious diseases at Brigham and Women’s Hospital and a co-PI of the Botswana Clinical Trials Unit at the Botswana Harvard AIDS Institute Partnership. She was not involved in the study. “One of the worst things for a mother and for pregnancy outcomes, for the fetus and baby’s health and development, is uncontrolled maternal HIV,’’ she said.

Dr. Lockman also noted potential confounders that drive poor birth outcomes in Southern African women, compared with U.S. women, making comparisons between this and other observational studies difficult. Still, she said that the question is not whether women should be receiving treatment but whether or not there are differences between antiretroviral regimens.

“One of the areas that we did not go deeper into was the subtype of antiretroviral therapy, given the relatively small study numbers [did not] allow us to do a robust analysis,” Dr. Venkatesh said.

Rather, he emphasized that the findings might lend more weight to speculation that immunologic characteristics associated with HIV status and immunotherapy – such as low CD4 cell counts prior to delivery, or duration of HIV infection – may be important drivers of adverse birth outcomes among women with HIV taking ART.

And at least in this cohort, many of these characteristics were similar between the treatment groups.

Both researchers agree that the findings – while reassuring – highlight the importance of collecting robust obstetric and safety data as part of prospective databases of individuals living with HIV, not only in resource-limited settings but also among the domestic U.S. population.

“We’ve learned a lot over the last 10 years,” Dr. Lockman said. “Some regimens (like lopinavir/ritonavir or nevirapine) are associated with significantly worse birth outcomes, whereas efavirenz doesn’t seem to be, or less so, and dolutegravir seems to be associated with even better outcomes. So, I think that where we are moving is to regimens that are the safest.”

Moving forward, Dr. Venkatesh explained, not only should researchers focus on exploring which antiretrovirals are safest in this context but also if the use of preexposure prophylaxis during conception periods affects birth outcomes.

Dr. Venkatesh and Dr. Lockman report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

“People don’t think about schizophrenia when they think about HIV,” Christina Mangurian, MD, professor of clinical psychiatry and vice chair for diversity and health equity at the University of California, San Francisco (UCSF), told this news organization.

University of California, San Francisco

The problem is complicated. According to the Centers for Disease Control and Prevention and National Institutes of Health, roughly 6% of people with serious mental illness are living with HIV, a rate that is about 10 times higher than the general U.S. population (0.4%). However, findings from a study by Dr. Mangurian and her team, published online in the journal AIDS, demonstrated that half of Medicaid patients with schizophrenia and HIV admitted to inpatient units in New York State were not coded as such upon discharge.

These data raise the question: How many people living with comorbid HIV and serious mental illness are diagnosed, virally suppressed, and/or lost to treatment as a result of the stigma associated with both conditions, lack of social support, and under-recognition by practitioners that a problem even exists?
 

Lost in the care continuum

Dr. Mangurian and her research team examined documentation of pre-existing HIV/AIDS diagnoses and absence of ICD-9-CM HIV/AIDS coding at psychiatric discharge among 14,602 adults (aged 18-64 years) admitted to hospital inpatient units in New York State between Jan. 1, 2012, and Dec. 31, 2013. HIV diagnoses were defined as recent (within 30 days of admission) or distant (within 30-366 days of admission), and first admission was used as the index in people with multiple hospitalizations.

People living with HIV comprised 5.1% (741) of the overall dataset; 34% were diagnosed with schizophrenia and 27.9% with bipolar disorders. Overall, 54.5% were male and 50.7% were non-Hispanic Black. Furthermore, 58.3% were discharged without HIV/AIDS ICD-9 coding, reinforcing the likelihood that they were lost in the care continuum.

Dr. Mangurian explained that this break in the chain of care upon discharge can have an important impact on efforts to break the cycle of HIV transmission.

“There’s data that people with serious mental illnesses like schizophrenia are less likely to have sex, but when they do they’re more likely to engage in risky sexual behaviors, including sex for money [and] unprotected sex with partners who use injection drugs or who have HIV,” she said.

Although the majority of patients – both with and without prior HIV diagnoses – were older, adjusted models demonstrated that people aged 18-24 years had more than twice the odds of having their HIV/AIDS undocumented at discharge, compared with older adults aged 55-64 years (adjusted odds ratio, 2.37; P = .038), as were those aged 25-34 years (aOR, 2.17; P = .003). Individuals with more distant HIV diagnoses had three times the odds for an undocumented HIV/AIDS discharge, compared with more recent diagnoses (aOR, 3.25; P < .001). 

Additional factors contributing to the lack of ICD-9 discharge coding included shorter lengths of stay (0-3 days vs. 15-30 days; aOR, 0.03; P = .01) and fewer HIV claims for HIV/AIDS services before hospitalization (1-2 vs. 3-9; aOR, 0.34; P < .01). Hospitals serving medium or high levels of Medicaid patients were also less likely to document HIV/AIDS before discharge (medium aOR, 1.69, P = .01; high aOR, 1.71, P = .03).

The study is not without limitations. For example, the 10-year-old dataset might not entirely reflect more recent structural or systemic changes for improving HIV detection on inpatient psychiatric units. Moreover, there was no comparator group without psychiatric inpatient admission.

Still, “[if these patients] didn’t have a discharge diagnosis, then it’s possible that they were not managed for their HIV, or their HIV was not addressed while they were in the hospital,” Sarah Andrews, MD, assistant professor of psychiatry and behavioral sciences and AIDS psychiatrist at Johns Hopkins School of Medicine, Baltimore, explained.

Johns Hopkins School of Medicine

Severe mental health an HIV disparity

Despite the burden of HIV among patient populations with serious mental health issues and data suggesting that these populations are over-represented among new HIV infections, the study findings point to an important missed opportunity for meeting several key outcomes on the HIV/AIDS care continuum, especially linkage to and retention in care.

The challenge is multifactorial.

In an earlier publication appearing in April 2021 in The Lancet HIV, Dr. Mangurian and colleagues explore a concept known as the “purview paradox,” which refers to a practitioner’s belief about who should be responsible for offering patients a particular intervention.

Structural and systemic issues also abound, as psychiatry records are often kept separate from the rest of the medical system due to insurer billing issues. “The true integration of all psychiatric and medical care has to happen to make sure that all of our patients receive the care that they deserve,” explained Dr. Mangurian.

Dr. Andrews agrees. “HIV care, as well as psychiatry, case management, pharmacy ... putting them together really helps decrease the risk of falling through the cracks and being able to refer appropriately for mental health,” she said.

Aside from changing practitioner attitudes and awareness and changing systems to include the wrap-around care model, current guidelines also need to reflect the role that patients with HIV and psychiatric comorbidities play in HIV transmission. Dr. Andrews and Dr. Mangurian agree: Routine screening in psychiatric inpatient units might be a good start.

The study was independently supported. Dr. Mangurian has reported grant funding from Genentech Charitable Foundation. Dr. Andrews has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.