MDedge Infectious Disease

Semaglutide improved metabolic dysfunction–associated steatotic liver disease (MASLD) among people living with HIV, and in some cases resolved it completely, according to results from the SLIM LIVER study presented by the AIDS Clinical Trials Group (ACTG) at this year’s Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver.

Furthermore, although muscle volume decreased with weight loss, participants did not experience significant changes in muscle quality or physical function.
 

‘A First’

SLIM LIVER is the first study evaluating semaglutide as a treatment of MASLD among people living with HIV.

The phase 2b, single-arm pilot study enrolled adults living with HIV who were virally suppressed and had central adiposity, insulin resistance or prediabetes, and steatotic liver disease.

Participants self-injected semaglutide weekly at increasing doses until they reached a 1-mg dose at week 4. At 24 weeks, the study team assessed changes in participants’ intra-hepatic triglyceride content using magnetic resonance imaging-proton density fat fraction.

The primary analysis results from SLIM LIVER were reported in an oral presentation, “Semaglutide Reduces Metabolic-Associated Steatotic Liver Disease in People With HIV: The SLIM LIVER Study,” on March 5 by Jordan E. Lake, MD, MSc, of UTHealth Houston.

A subgroup analysis of the study was provided in a poster, “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER Study,” presented on March 4 by Grace L. Ditzenberger, PT, DPT, of the University of Colorado Anschutz Medical Campus in Aurora.

In the primary analysis, the median age of the 49 participants was 52 years, 43% were women (cisgender and transgender), the mean body mass index was 35, 39% were Hispanic and 33% were Black/African American, and 82% were taking antiretroviral therapy that included an integrase inhibitor.

Liver fat was reduced by an average of 31%, with 29% of participants experiencing a complete resolution (5% or less liver fat) of MASLD. They also experienced weight loss, reduced fasting blood glucose, and reduced fasting triglycerides, consistent with effects observed in studies of semaglutide in people without HIV.

The sub-analysis of the 46 participants for whom muscle measurements were available showed that muscle volume (measured in the psoas) decreased but with no significant change in physical function.

Semaglutide was generally well tolerated, with an adverse event profile similar to that seen in individuals without HIV.

The most common adverse events were gastrointestinal (ie, nausea, diarrhea, vomiting, and abdominal pain). Two participants experienced more significant adverse events possibly related to semaglutide but were able to continue in the study.

All participants completed the full 24 weeks of therapy at the originally prescribed dose.
 

Potential Impact

“Even at the low dose of 1 mg every week, most participants lost significant weight, and weight loss was closely associated with improvements in MASLD,” Dr. Lake said. “Additional research will assess the secondary effects of semaglutide on systemic inflammation and metabolism and determine whether semaglutide may have unique risks or benefits for people living with HIV.”

“These findings have the potential to have a significant impact on the health and quality of life of people living with HIV,” added ACTG Chair Judith Currier, MD, MSc, University of California Los Angeles.

The SLIM LIVER study was sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), with additional funding from UTHealth Houston McGovern School of Medicine. ACTG is a clinical trials network focused on HIV and other infectious diseases, funded by NIAID and collaborating institutes of the US National Institutes of Health.

No conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

Semaglutide improved metabolic dysfunction–associated steatotic liver disease (MASLD) among people living with HIV, and in some cases resolved it completely, according to results from the SLIM LIVER study presented by the AIDS Clinical Trials Group (ACTG) at this year’s Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver.

Furthermore, although muscle volume decreased with weight loss, participants did not experience significant changes in muscle quality or physical function.
 

‘A First’

SLIM LIVER is the first study evaluating semaglutide as a treatment of MASLD among people living with HIV.

The phase 2b, single-arm pilot study enrolled adults living with HIV who were virally suppressed and had central adiposity, insulin resistance or prediabetes, and steatotic liver disease.

Participants self-injected semaglutide weekly at increasing doses until they reached a 1-mg dose at week 4. At 24 weeks, the study team assessed changes in participants’ intra-hepatic triglyceride content using magnetic resonance imaging-proton density fat fraction.

The primary analysis results from SLIM LIVER were reported in an oral presentation, “Semaglutide Reduces Metabolic-Associated Steatotic Liver Disease in People With HIV: The SLIM LIVER Study,” on March 5 by Jordan E. Lake, MD, MSc, of UTHealth Houston.

A subgroup analysis of the study was provided in a poster, “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER Study,” presented on March 4 by Grace L. Ditzenberger, PT, DPT, of the University of Colorado Anschutz Medical Campus in Aurora.

In the primary analysis, the median age of the 49 participants was 52 years, 43% were women (cisgender and transgender), the mean body mass index was 35, 39% were Hispanic and 33% were Black/African American, and 82% were taking antiretroviral therapy that included an integrase inhibitor.

Liver fat was reduced by an average of 31%, with 29% of participants experiencing a complete resolution (5% or less liver fat) of MASLD. They also experienced weight loss, reduced fasting blood glucose, and reduced fasting triglycerides, consistent with effects observed in studies of semaglutide in people without HIV.

The sub-analysis of the 46 participants for whom muscle measurements were available showed that muscle volume (measured in the psoas) decreased but with no significant change in physical function.

Semaglutide was generally well tolerated, with an adverse event profile similar to that seen in individuals without HIV.

The most common adverse events were gastrointestinal (ie, nausea, diarrhea, vomiting, and abdominal pain). Two participants experienced more significant adverse events possibly related to semaglutide but were able to continue in the study.

All participants completed the full 24 weeks of therapy at the originally prescribed dose.
 

Potential Impact

“Even at the low dose of 1 mg every week, most participants lost significant weight, and weight loss was closely associated with improvements in MASLD,” Dr. Lake said. “Additional research will assess the secondary effects of semaglutide on systemic inflammation and metabolism and determine whether semaglutide may have unique risks or benefits for people living with HIV.”

“These findings have the potential to have a significant impact on the health and quality of life of people living with HIV,” added ACTG Chair Judith Currier, MD, MSc, University of California Los Angeles.

The SLIM LIVER study was sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), with additional funding from UTHealth Houston McGovern School of Medicine. ACTG is a clinical trials network focused on HIV and other infectious diseases, funded by NIAID and collaborating institutes of the US National Institutes of Health.

No conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

Semaglutide improved metabolic dysfunction–associated steatotic liver disease (MASLD) among people living with HIV, and in some cases resolved it completely, according to results from the SLIM LIVER study presented by the AIDS Clinical Trials Group (ACTG) at this year’s Conference on Retroviruses and Opportunistic Infections (CROI) 2024 Annual Meeting in Denver.

Furthermore, although muscle volume decreased with weight loss, participants did not experience significant changes in muscle quality or physical function.
 

‘A First’

SLIM LIVER is the first study evaluating semaglutide as a treatment of MASLD among people living with HIV.

The phase 2b, single-arm pilot study enrolled adults living with HIV who were virally suppressed and had central adiposity, insulin resistance or prediabetes, and steatotic liver disease.

Participants self-injected semaglutide weekly at increasing doses until they reached a 1-mg dose at week 4. At 24 weeks, the study team assessed changes in participants’ intra-hepatic triglyceride content using magnetic resonance imaging-proton density fat fraction.

The primary analysis results from SLIM LIVER were reported in an oral presentation, “Semaglutide Reduces Metabolic-Associated Steatotic Liver Disease in People With HIV: The SLIM LIVER Study,” on March 5 by Jordan E. Lake, MD, MSc, of UTHealth Houston.

A subgroup analysis of the study was provided in a poster, “Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER Study,” presented on March 4 by Grace L. Ditzenberger, PT, DPT, of the University of Colorado Anschutz Medical Campus in Aurora.

In the primary analysis, the median age of the 49 participants was 52 years, 43% were women (cisgender and transgender), the mean body mass index was 35, 39% were Hispanic and 33% were Black/African American, and 82% were taking antiretroviral therapy that included an integrase inhibitor.

Liver fat was reduced by an average of 31%, with 29% of participants experiencing a complete resolution (5% or less liver fat) of MASLD. They also experienced weight loss, reduced fasting blood glucose, and reduced fasting triglycerides, consistent with effects observed in studies of semaglutide in people without HIV.

The sub-analysis of the 46 participants for whom muscle measurements were available showed that muscle volume (measured in the psoas) decreased but with no significant change in physical function.

Semaglutide was generally well tolerated, with an adverse event profile similar to that seen in individuals without HIV.

The most common adverse events were gastrointestinal (ie, nausea, diarrhea, vomiting, and abdominal pain). Two participants experienced more significant adverse events possibly related to semaglutide but were able to continue in the study.

All participants completed the full 24 weeks of therapy at the originally prescribed dose.
 

Potential Impact

“Even at the low dose of 1 mg every week, most participants lost significant weight, and weight loss was closely associated with improvements in MASLD,” Dr. Lake said. “Additional research will assess the secondary effects of semaglutide on systemic inflammation and metabolism and determine whether semaglutide may have unique risks or benefits for people living with HIV.”

“These findings have the potential to have a significant impact on the health and quality of life of people living with HIV,” added ACTG Chair Judith Currier, MD, MSc, University of California Los Angeles.

The SLIM LIVER study was sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), with additional funding from UTHealth Houston McGovern School of Medicine. ACTG is a clinical trials network focused on HIV and other infectious diseases, funded by NIAID and collaborating institutes of the US National Institutes of Health.

No conflicts of interest were reported.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A multicomponent strategy of nurse-led communication, home blood pressure monitoring, evidence-based treatment algorithms, and electronic health record tools improved systolic blood pressure (SBP) and non–high-density lipoprotein (non-HDL) cholesterol levels in people living with HIV.

METHODOLOGY:

• Investigators assessed if EXTRA-CVD, a nurse-led multicomponent intervention for preventing cardiovascular diseases (CVD), could effectively improve SBP and non-HDL cholesterol levels in people living with HIV whose viral replication has been controlled effectively using antiretroviral therapy.
• They recruited 297 individuals (median age, 59 years; 20.9% women) from three academic HIV clinics in the United States with an HIV-1 viral load < 200 copies/mL who were diagnosed with both hypertension and hypercholesterolemia.
• Participants were randomly assigned to either the EXTRA-CVD intervention group or a control group comprising individuals who received general prevention education.
• SBP (the primary outcome) was calculated as the mean of two SBP measurements obtained 1 minute apart, and non-HDL cholesterol (the secondary outcome) was calculated as total cholesterol minus HDL cholesterol.

TAKEAWAY:

• Participants in the intervention vs control group reported having significantly lower SBP as early as 4 months after the nurse-led strategy (mean difference, −6.4 mm Hg; P = .002), with the improvements sustaining until 12 months (mean difference, −4.2 mm Hg; P = .04).
• At 12 months, participants in the intervention group showed a 16.9-mg/dL (P < .001) reduction in non-HDL cholesterol levels compared with those in the control group.
• The nurse-led strategy led to a greater reduction in SBP in women with HIV vs men living with HIV (5.9 mm Hg greater SBP difference at 12 months), with the difference being clinically meaningful but not statistically significant.
• This nurse-led strategy did not increase the risk for adverse events in people living with HIV.

IN PRACTICE:

“Although the EXTRA-CVD intervention was limited to BP and cholesterol, nurse-led case management might be beneficial for a range of other primary care conditions in HIV clinics. If HIV clinics choose to implement EXTRA-CVD, they might consider adding staff trained in other chronic comorbidities and/or health promotion activities,” the authors noted.

SOURCE:

This study was led by Christopher T. Longenecker, MD, University of Washington School of Medicine, Seattle, and published online on March 5, 2024, in JAMA Network Open.

LIMITATIONS:

Because this trial was conducted at well-resourced, major academic HIV clinics, the results may not be applicable to other populations, such as smaller community-based clinics or HIV care outside the United States. The sensitivity analyses performed in this study may not have fully accounted for the bias introduced by the differential attrition in the intervention group.

DISCLOSURES:

This study was supported by grants from the National Institutes of Health (NIH). The authors declared receiving grants and personal fees from or having other ties with the NIH and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A multicomponent strategy of nurse-led communication, home blood pressure monitoring, evidence-based treatment algorithms, and electronic health record tools improved systolic blood pressure (SBP) and non–high-density lipoprotein (non-HDL) cholesterol levels in people living with HIV.

METHODOLOGY:

• Investigators assessed if EXTRA-CVD, a nurse-led multicomponent intervention for preventing cardiovascular diseases (CVD), could effectively improve SBP and non-HDL cholesterol levels in people living with HIV whose viral replication has been controlled effectively using antiretroviral therapy.
• They recruited 297 individuals (median age, 59 years; 20.9% women) from three academic HIV clinics in the United States with an HIV-1 viral load < 200 copies/mL who were diagnosed with both hypertension and hypercholesterolemia.
• Participants were randomly assigned to either the EXTRA-CVD intervention group or a control group comprising individuals who received general prevention education.
• SBP (the primary outcome) was calculated as the mean of two SBP measurements obtained 1 minute apart, and non-HDL cholesterol (the secondary outcome) was calculated as total cholesterol minus HDL cholesterol.

TAKEAWAY:

• Participants in the intervention vs control group reported having significantly lower SBP as early as 4 months after the nurse-led strategy (mean difference, −6.4 mm Hg; P = .002), with the improvements sustaining until 12 months (mean difference, −4.2 mm Hg; P = .04).
• At 12 months, participants in the intervention group showed a 16.9-mg/dL (P < .001) reduction in non-HDL cholesterol levels compared with those in the control group.
• The nurse-led strategy led to a greater reduction in SBP in women with HIV vs men living with HIV (5.9 mm Hg greater SBP difference at 12 months), with the difference being clinically meaningful but not statistically significant.
• This nurse-led strategy did not increase the risk for adverse events in people living with HIV.

IN PRACTICE:

“Although the EXTRA-CVD intervention was limited to BP and cholesterol, nurse-led case management might be beneficial for a range of other primary care conditions in HIV clinics. If HIV clinics choose to implement EXTRA-CVD, they might consider adding staff trained in other chronic comorbidities and/or health promotion activities,” the authors noted.

SOURCE:

This study was led by Christopher T. Longenecker, MD, University of Washington School of Medicine, Seattle, and published online on March 5, 2024, in JAMA Network Open.

LIMITATIONS:

Because this trial was conducted at well-resourced, major academic HIV clinics, the results may not be applicable to other populations, such as smaller community-based clinics or HIV care outside the United States. The sensitivity analyses performed in this study may not have fully accounted for the bias introduced by the differential attrition in the intervention group.

DISCLOSURES:

This study was supported by grants from the National Institutes of Health (NIH). The authors declared receiving grants and personal fees from or having other ties with the NIH and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A multicomponent strategy of nurse-led communication, home blood pressure monitoring, evidence-based treatment algorithms, and electronic health record tools improved systolic blood pressure (SBP) and non–high-density lipoprotein (non-HDL) cholesterol levels in people living with HIV.

METHODOLOGY:

• Investigators assessed if EXTRA-CVD, a nurse-led multicomponent intervention for preventing cardiovascular diseases (CVD), could effectively improve SBP and non-HDL cholesterol levels in people living with HIV whose viral replication has been controlled effectively using antiretroviral therapy.
• They recruited 297 individuals (median age, 59 years; 20.9% women) from three academic HIV clinics in the United States with an HIV-1 viral load < 200 copies/mL who were diagnosed with both hypertension and hypercholesterolemia.
• Participants were randomly assigned to either the EXTRA-CVD intervention group or a control group comprising individuals who received general prevention education.
• SBP (the primary outcome) was calculated as the mean of two SBP measurements obtained 1 minute apart, and non-HDL cholesterol (the secondary outcome) was calculated as total cholesterol minus HDL cholesterol.

TAKEAWAY:

• Participants in the intervention vs control group reported having significantly lower SBP as early as 4 months after the nurse-led strategy (mean difference, −6.4 mm Hg; P = .002), with the improvements sustaining until 12 months (mean difference, −4.2 mm Hg; P = .04).
• At 12 months, participants in the intervention group showed a 16.9-mg/dL (P < .001) reduction in non-HDL cholesterol levels compared with those in the control group.
• The nurse-led strategy led to a greater reduction in SBP in women with HIV vs men living with HIV (5.9 mm Hg greater SBP difference at 12 months), with the difference being clinically meaningful but not statistically significant.
• This nurse-led strategy did not increase the risk for adverse events in people living with HIV.

IN PRACTICE:

“Although the EXTRA-CVD intervention was limited to BP and cholesterol, nurse-led case management might be beneficial for a range of other primary care conditions in HIV clinics. If HIV clinics choose to implement EXTRA-CVD, they might consider adding staff trained in other chronic comorbidities and/or health promotion activities,” the authors noted.

SOURCE:

This study was led by Christopher T. Longenecker, MD, University of Washington School of Medicine, Seattle, and published online on March 5, 2024, in JAMA Network Open.

LIMITATIONS:

Because this trial was conducted at well-resourced, major academic HIV clinics, the results may not be applicable to other populations, such as smaller community-based clinics or HIV care outside the United States. The sensitivity analyses performed in this study may not have fully accounted for the bias introduced by the differential attrition in the intervention group.

DISCLOSURES:

This study was supported by grants from the National Institutes of Health (NIH). The authors declared receiving grants and personal fees from or having other ties with the NIH and other sources.

A version of this article appeared on Medscape.com.

SAN DIEGO — Multiple topical and systemic medications are safe for treating pregnant women with bacterial, viral, and fungal infections, a dermatologist told colleagues at the annual meeting of the American Academy of Dermatology. However, several drugs should be avoided or used with caution because of potential risks during pregnancy. 

When treating bacterial infections in pregnant women, there are many options, “especially for the sort of short-term antibiotic use that we tend to use for treating infections,” said Jenny Murase, MD, of the Palo Alto Foundation Medical Group and the University of California San Francisco.

During a presentation on treating infections in pregnant patients, she made the following recommendations for treating pyogenic infections: 

• Impetigo: First-line treatments are topical mupirocin, oral first-generation cephalosporins, and oral dicloxacillin.
• Cellulitis: Recommended treatments are oral or intravenous penicillin, oral first-generation cephalosporins, and oral dicloxacillin.
• Methicillin-resistant Staphylococcus aureus (MRSA): “Clindamycin is first-line, dependent on bacteria culture and sensitivities,” and because of its safety, “it’s a really good choice for a pregnant woman.” Dr. Murase said. However, be aware of potential inducible resistance and test for the erm gene, she said.
• Abscesses: Incision and drainage are recommended. “Whenever we’re managing a patient with a condition during pregnancy, we want to try to use nonmedications when possible,” Dr. Murase said. “No antibiotic is necessary unless the abscess is greater than 5 cm or if it’s greater than 2 cm with erythema around the abscess.”
• Tuberculosis: The best strategy is rifampin, but peripartum vitamin K prophylaxis for mother and fetus should be used, she said. 

General Infections

With regard to antibiotics to treat general infections — for instance, if a patient with atopic dermatitis has a secondary skin infection — Dr. Murase recommended first-line oral antibiotic therapy with penicillin, first-generation cephalosporins, or dicloxacillin. For second-line therapy, erythromycin is the preferred macrolide over azithromycin and clarithromycin, she said. 

She noted that there is an increased risk for atrial/ventricular septal defects and pyloric stenosis associated with the use of erythromycin when used during the first trimester of pregnancy. In addition, erythromycin estolate increases the risk of liver toxicity, while erythromycin base and erythromycin ethylsuccinate do not. 

Sulfonamides are a second-line line choice up until the third trimester. If given to a patient in the first trimester, she said, “make sure that they are supplementing with folic acid efficiently, at least 0.5 mg a day.” During the peripartum period they are contraindicated, as they pose a risk for hemolytic anemia, hyperbilirubinemia, and kernicterus.

The combination drug trimethoprim/sulfamethoxazole is a second-line choice for complicated infections because of the associated risk for low birth weight and prematurity, Dr. Murase said.

Quinolones are also a second-line option during pregnancy she said, and ciprofloxacin and norfloxacin have been studied the most. “If you have to choose a quinolone for a complicated infection in pregnancy, those would be the quinolones of choice,” Dr. Murase said.

Considering the bad reputation of tetracyclines in pregnancy, dermatologists may be surprised to learn that they are considered a second-line therapy up to 14 weeks’ gestation, she said. After that time, however, they’re contraindicated because of bone growth inhibition, teeth discoloration, and maternal hepatitis.


 

Fungal Infections

As for fungal infections, clotrimazole is the first choice for topical treatment of tinea corporis, followed by miconazole and then ketoconazole, according to Dr. Murase. There are limited data for topical terbinafine, naftifine, and ciclopirox during pregnancy she noted, but they are likely safe.

There is also limited data about these drugs when used for topical treatment of candidiasis during pregnancy. Nystatin is safe, but less effective than other options, Dr. Murase said. Other options include clotrimazole, miconazole, and ketoconazole, which, in animals exposed to high doses, have not been associated with defects, and topical gentian violet (0.5%-1% solution), she noted.

For topical treatment of tinea versicolor during pregnancy, limited application of clotrimazole or miconazole is considered safe, and zinc pyrithione soap or topical benzoyl peroxide soap can be used for more widespread areas. 

Dr. Murase recommended caution when using selenium sulfide since poisoning has been linked to miscarriages, she said. Limited application appears to be safe, “so make sure that the patient is using it on smaller body surface areas.”

As for systemic antifungal treatments, fluconazole, ketoconazole, and itraconazole should be avoided in pregnancy because of the risks of craniosynostosis, congenital heart defects, and skeletal anomalies, Dr. Murase said. However, she referred to a study that found no increased risk of congenital malformations with fluconazole during the first trimester, and a patient could be reassured if, for example, she was treated for a yeast infection before she knew she was pregnant, she said.

Griseofulvin is not recommended during pregnancy, but a 2020 study suggests that terbinafine is safe, she said. In that study, oral or topical terbinafine did not appear to be associated with an increased risk for spontaneous abortion or major malformations. “Certainly, we can wait until after the pregnancy to treat onychomycosis. But I have had situations that even in spite of regular topical therapy, pregnant patients needed to take some kind of oral agent” because of severe itching. 

Viral Infections

For herpes simplex, acyclovir is the top choice, and famciclovir and valacyclovir (Valtrex) are likely safe, but daily prophylaxis is not recommended during pregnancy, Dr. Murase said. 

Because of a lack of data, podofilox, cantharidin, and imiquimod for treating human papillomavirus (HPV) should be avoided, she said. Podophyllin is extremely dangerous in pregnancy and has been linked to maternal and fetal deaths, and malformations, and is contraindicated in pregnancy, she added.

Instead, liquid nitrogen is the treatment of choice for HPV in pregnant patients, she said. 

Trichloracetic acid is the treatment of choice for condylomata acuminata, and squaric acid or intralesional Candida antigen injection for periungual verrucas can be used, she said, and limited applications of salicylic acid are considered safe. 

Dr. Murase highlighted a 2014 paper that she coauthored on the safety of dermatologic medications during pregnancy, noting that an updated report will be published later this year.

Dr. Murase disclosed relationships with Regeneron and UCB (speaker), Sanofi/Regeneron and Bristol-Myers Squibb (advisory board), and UCB, AbbVie, and UpToDate (consulting). 
 

A version of this article appeared on Medscape.com.

SAN DIEGO — Multiple topical and systemic medications are safe for treating pregnant women with bacterial, viral, and fungal infections, a dermatologist told colleagues at the annual meeting of the American Academy of Dermatology. However, several drugs should be avoided or used with caution because of potential risks during pregnancy. 

When treating bacterial infections in pregnant women, there are many options, “especially for the sort of short-term antibiotic use that we tend to use for treating infections,” said Jenny Murase, MD, of the Palo Alto Foundation Medical Group and the University of California San Francisco.

During a presentation on treating infections in pregnant patients, she made the following recommendations for treating pyogenic infections: 

• Impetigo: First-line treatments are topical mupirocin, oral first-generation cephalosporins, and oral dicloxacillin.
• Cellulitis: Recommended treatments are oral or intravenous penicillin, oral first-generation cephalosporins, and oral dicloxacillin.
• Methicillin-resistant Staphylococcus aureus (MRSA): “Clindamycin is first-line, dependent on bacteria culture and sensitivities,” and because of its safety, “it’s a really good choice for a pregnant woman.” Dr. Murase said. However, be aware of potential inducible resistance and test for the erm gene, she said.
• Abscesses: Incision and drainage are recommended. “Whenever we’re managing a patient with a condition during pregnancy, we want to try to use nonmedications when possible,” Dr. Murase said. “No antibiotic is necessary unless the abscess is greater than 5 cm or if it’s greater than 2 cm with erythema around the abscess.”
• Tuberculosis: The best strategy is rifampin, but peripartum vitamin K prophylaxis for mother and fetus should be used, she said. 

General Infections

With regard to antibiotics to treat general infections — for instance, if a patient with atopic dermatitis has a secondary skin infection — Dr. Murase recommended first-line oral antibiotic therapy with penicillin, first-generation cephalosporins, or dicloxacillin. For second-line therapy, erythromycin is the preferred macrolide over azithromycin and clarithromycin, she said. 

She noted that there is an increased risk for atrial/ventricular septal defects and pyloric stenosis associated with the use of erythromycin when used during the first trimester of pregnancy. In addition, erythromycin estolate increases the risk of liver toxicity, while erythromycin base and erythromycin ethylsuccinate do not. 

Sulfonamides are a second-line line choice up until the third trimester. If given to a patient in the first trimester, she said, “make sure that they are supplementing with folic acid efficiently, at least 0.5 mg a day.” During the peripartum period they are contraindicated, as they pose a risk for hemolytic anemia, hyperbilirubinemia, and kernicterus.

The combination drug trimethoprim/sulfamethoxazole is a second-line choice for complicated infections because of the associated risk for low birth weight and prematurity, Dr. Murase said.

Quinolones are also a second-line option during pregnancy she said, and ciprofloxacin and norfloxacin have been studied the most. “If you have to choose a quinolone for a complicated infection in pregnancy, those would be the quinolones of choice,” Dr. Murase said.

Considering the bad reputation of tetracyclines in pregnancy, dermatologists may be surprised to learn that they are considered a second-line therapy up to 14 weeks’ gestation, she said. After that time, however, they’re contraindicated because of bone growth inhibition, teeth discoloration, and maternal hepatitis.


 

Fungal Infections

As for fungal infections, clotrimazole is the first choice for topical treatment of tinea corporis, followed by miconazole and then ketoconazole, according to Dr. Murase. There are limited data for topical terbinafine, naftifine, and ciclopirox during pregnancy she noted, but they are likely safe.

There is also limited data about these drugs when used for topical treatment of candidiasis during pregnancy. Nystatin is safe, but less effective than other options, Dr. Murase said. Other options include clotrimazole, miconazole, and ketoconazole, which, in animals exposed to high doses, have not been associated with defects, and topical gentian violet (0.5%-1% solution), she noted.

For topical treatment of tinea versicolor during pregnancy, limited application of clotrimazole or miconazole is considered safe, and zinc pyrithione soap or topical benzoyl peroxide soap can be used for more widespread areas. 

Dr. Murase recommended caution when using selenium sulfide since poisoning has been linked to miscarriages, she said. Limited application appears to be safe, “so make sure that the patient is using it on smaller body surface areas.”

As for systemic antifungal treatments, fluconazole, ketoconazole, and itraconazole should be avoided in pregnancy because of the risks of craniosynostosis, congenital heart defects, and skeletal anomalies, Dr. Murase said. However, she referred to a study that found no increased risk of congenital malformations with fluconazole during the first trimester, and a patient could be reassured if, for example, she was treated for a yeast infection before she knew she was pregnant, she said.

Griseofulvin is not recommended during pregnancy, but a 2020 study suggests that terbinafine is safe, she said. In that study, oral or topical terbinafine did not appear to be associated with an increased risk for spontaneous abortion or major malformations. “Certainly, we can wait until after the pregnancy to treat onychomycosis. But I have had situations that even in spite of regular topical therapy, pregnant patients needed to take some kind of oral agent” because of severe itching. 

Viral Infections

For herpes simplex, acyclovir is the top choice, and famciclovir and valacyclovir (Valtrex) are likely safe, but daily prophylaxis is not recommended during pregnancy, Dr. Murase said. 

Because of a lack of data, podofilox, cantharidin, and imiquimod for treating human papillomavirus (HPV) should be avoided, she said. Podophyllin is extremely dangerous in pregnancy and has been linked to maternal and fetal deaths, and malformations, and is contraindicated in pregnancy, she added.

Instead, liquid nitrogen is the treatment of choice for HPV in pregnant patients, she said. 

Trichloracetic acid is the treatment of choice for condylomata acuminata, and squaric acid or intralesional Candida antigen injection for periungual verrucas can be used, she said, and limited applications of salicylic acid are considered safe. 

Dr. Murase highlighted a 2014 paper that she coauthored on the safety of dermatologic medications during pregnancy, noting that an updated report will be published later this year.

Dr. Murase disclosed relationships with Regeneron and UCB (speaker), Sanofi/Regeneron and Bristol-Myers Squibb (advisory board), and UCB, AbbVie, and UpToDate (consulting). 
 

A version of this article appeared on Medscape.com.

SAN DIEGO — Multiple topical and systemic medications are safe for treating pregnant women with bacterial, viral, and fungal infections, a dermatologist told colleagues at the annual meeting of the American Academy of Dermatology. However, several drugs should be avoided or used with caution because of potential risks during pregnancy. 

When treating bacterial infections in pregnant women, there are many options, “especially for the sort of short-term antibiotic use that we tend to use for treating infections,” said Jenny Murase, MD, of the Palo Alto Foundation Medical Group and the University of California San Francisco.

During a presentation on treating infections in pregnant patients, she made the following recommendations for treating pyogenic infections: 

• Impetigo: First-line treatments are topical mupirocin, oral first-generation cephalosporins, and oral dicloxacillin.
• Cellulitis: Recommended treatments are oral or intravenous penicillin, oral first-generation cephalosporins, and oral dicloxacillin.
• Methicillin-resistant Staphylococcus aureus (MRSA): “Clindamycin is first-line, dependent on bacteria culture and sensitivities,” and because of its safety, “it’s a really good choice for a pregnant woman.” Dr. Murase said. However, be aware of potential inducible resistance and test for the erm gene, she said.
• Abscesses: Incision and drainage are recommended. “Whenever we’re managing a patient with a condition during pregnancy, we want to try to use nonmedications when possible,” Dr. Murase said. “No antibiotic is necessary unless the abscess is greater than 5 cm or if it’s greater than 2 cm with erythema around the abscess.”
• Tuberculosis: The best strategy is rifampin, but peripartum vitamin K prophylaxis for mother and fetus should be used, she said. 

General Infections

With regard to antibiotics to treat general infections — for instance, if a patient with atopic dermatitis has a secondary skin infection — Dr. Murase recommended first-line oral antibiotic therapy with penicillin, first-generation cephalosporins, or dicloxacillin. For second-line therapy, erythromycin is the preferred macrolide over azithromycin and clarithromycin, she said. 

She noted that there is an increased risk for atrial/ventricular septal defects and pyloric stenosis associated with the use of erythromycin when used during the first trimester of pregnancy. In addition, erythromycin estolate increases the risk of liver toxicity, while erythromycin base and erythromycin ethylsuccinate do not. 

Sulfonamides are a second-line line choice up until the third trimester. If given to a patient in the first trimester, she said, “make sure that they are supplementing with folic acid efficiently, at least 0.5 mg a day.” During the peripartum period they are contraindicated, as they pose a risk for hemolytic anemia, hyperbilirubinemia, and kernicterus.

The combination drug trimethoprim/sulfamethoxazole is a second-line choice for complicated infections because of the associated risk for low birth weight and prematurity, Dr. Murase said.

Quinolones are also a second-line option during pregnancy she said, and ciprofloxacin and norfloxacin have been studied the most. “If you have to choose a quinolone for a complicated infection in pregnancy, those would be the quinolones of choice,” Dr. Murase said.

Considering the bad reputation of tetracyclines in pregnancy, dermatologists may be surprised to learn that they are considered a second-line therapy up to 14 weeks’ gestation, she said. After that time, however, they’re contraindicated because of bone growth inhibition, teeth discoloration, and maternal hepatitis.


 

Fungal Infections

As for fungal infections, clotrimazole is the first choice for topical treatment of tinea corporis, followed by miconazole and then ketoconazole, according to Dr. Murase. There are limited data for topical terbinafine, naftifine, and ciclopirox during pregnancy she noted, but they are likely safe.

There is also limited data about these drugs when used for topical treatment of candidiasis during pregnancy. Nystatin is safe, but less effective than other options, Dr. Murase said. Other options include clotrimazole, miconazole, and ketoconazole, which, in animals exposed to high doses, have not been associated with defects, and topical gentian violet (0.5%-1% solution), she noted.

For topical treatment of tinea versicolor during pregnancy, limited application of clotrimazole or miconazole is considered safe, and zinc pyrithione soap or topical benzoyl peroxide soap can be used for more widespread areas. 

Dr. Murase recommended caution when using selenium sulfide since poisoning has been linked to miscarriages, she said. Limited application appears to be safe, “so make sure that the patient is using it on smaller body surface areas.”

As for systemic antifungal treatments, fluconazole, ketoconazole, and itraconazole should be avoided in pregnancy because of the risks of craniosynostosis, congenital heart defects, and skeletal anomalies, Dr. Murase said. However, she referred to a study that found no increased risk of congenital malformations with fluconazole during the first trimester, and a patient could be reassured if, for example, she was treated for a yeast infection before she knew she was pregnant, she said.

Griseofulvin is not recommended during pregnancy, but a 2020 study suggests that terbinafine is safe, she said. In that study, oral or topical terbinafine did not appear to be associated with an increased risk for spontaneous abortion or major malformations. “Certainly, we can wait until after the pregnancy to treat onychomycosis. But I have had situations that even in spite of regular topical therapy, pregnant patients needed to take some kind of oral agent” because of severe itching. 

Viral Infections

For herpes simplex, acyclovir is the top choice, and famciclovir and valacyclovir (Valtrex) are likely safe, but daily prophylaxis is not recommended during pregnancy, Dr. Murase said. 

Because of a lack of data, podofilox, cantharidin, and imiquimod for treating human papillomavirus (HPV) should be avoided, she said. Podophyllin is extremely dangerous in pregnancy and has been linked to maternal and fetal deaths, and malformations, and is contraindicated in pregnancy, she added.

Instead, liquid nitrogen is the treatment of choice for HPV in pregnant patients, she said. 

Trichloracetic acid is the treatment of choice for condylomata acuminata, and squaric acid or intralesional Candida antigen injection for periungual verrucas can be used, she said, and limited applications of salicylic acid are considered safe. 

Dr. Murase highlighted a 2014 paper that she coauthored on the safety of dermatologic medications during pregnancy, noting that an updated report will be published later this year.

Dr. Murase disclosed relationships with Regeneron and UCB (speaker), Sanofi/Regeneron and Bristol-Myers Squibb (advisory board), and UCB, AbbVie, and UpToDate (consulting). 
 

A version of this article appeared on Medscape.com.

Scientists at the University of California, San Francisco, have discovered that remnants of the COVID-19 virus can linger in blood and tissue for more than a year after a person is first infected.

In their research on long COVID, the scientists found COVID antigens in the blood for up to 14 months after infection, and in tissue samples for more than 2 years after infection. 

“These two studies provide some of the strongest evidence so far that COVID antigens can persist in some people, even though we think they have normal immune responses,” Michael Peluso, MD, an infectious disease researcher in the UCSF School of Medicine, who led both studies, said in a statement. 

Scientists don’t know what causes long COVID, in which symptoms of the illness persist months or years after recovery. The most common symptoms are extreme fatigue, shortness of breath, loss of smell, and muscle aches.

The UCSF research team examined blood samples from 171 infected people and found the COVID “spike” protein was still present up to 14 months after infection in some people. The antigens were found more often in people who were hospitalized with COVID or who reported being very sick but were not hospitalized.

Researchers next looked at the UCSF Long COVID Tissue Bank, which contains samples donated by patients with and without long COVID. 

They found portions of viral RNA in the tissue up to 2 years after people were infected, though there was no evidence of reinfection. Those viral fragments were found in connective tissue where immune cells are, suggesting that the fragments caused the immune system to attack, according to the researchers. 

The UCSF team is running clinical trials to find out if monoclonal antibodies or antiviral drugs can remove the virus. 

The findings were presented in Denver this week at the Conference on Retroviruses and Opportunistic Infections.

A version of this article appeared on WebMD.com.

Scientists at the University of California, San Francisco, have discovered that remnants of the COVID-19 virus can linger in blood and tissue for more than a year after a person is first infected.

In their research on long COVID, the scientists found COVID antigens in the blood for up to 14 months after infection, and in tissue samples for more than 2 years after infection. 

“These two studies provide some of the strongest evidence so far that COVID antigens can persist in some people, even though we think they have normal immune responses,” Michael Peluso, MD, an infectious disease researcher in the UCSF School of Medicine, who led both studies, said in a statement. 

Scientists don’t know what causes long COVID, in which symptoms of the illness persist months or years after recovery. The most common symptoms are extreme fatigue, shortness of breath, loss of smell, and muscle aches.

The UCSF research team examined blood samples from 171 infected people and found the COVID “spike” protein was still present up to 14 months after infection in some people. The antigens were found more often in people who were hospitalized with COVID or who reported being very sick but were not hospitalized.

Researchers next looked at the UCSF Long COVID Tissue Bank, which contains samples donated by patients with and without long COVID. 

They found portions of viral RNA in the tissue up to 2 years after people were infected, though there was no evidence of reinfection. Those viral fragments were found in connective tissue where immune cells are, suggesting that the fragments caused the immune system to attack, according to the researchers. 

The UCSF team is running clinical trials to find out if monoclonal antibodies or antiviral drugs can remove the virus. 

The findings were presented in Denver this week at the Conference on Retroviruses and Opportunistic Infections.

A version of this article appeared on WebMD.com.

Scientists at the University of California, San Francisco, have discovered that remnants of the COVID-19 virus can linger in blood and tissue for more than a year after a person is first infected.

In their research on long COVID, the scientists found COVID antigens in the blood for up to 14 months after infection, and in tissue samples for more than 2 years after infection. 

“These two studies provide some of the strongest evidence so far that COVID antigens can persist in some people, even though we think they have normal immune responses,” Michael Peluso, MD, an infectious disease researcher in the UCSF School of Medicine, who led both studies, said in a statement. 

Scientists don’t know what causes long COVID, in which symptoms of the illness persist months or years after recovery. The most common symptoms are extreme fatigue, shortness of breath, loss of smell, and muscle aches.

The UCSF research team examined blood samples from 171 infected people and found the COVID “spike” protein was still present up to 14 months after infection in some people. The antigens were found more often in people who were hospitalized with COVID or who reported being very sick but were not hospitalized.

Researchers next looked at the UCSF Long COVID Tissue Bank, which contains samples donated by patients with and without long COVID. 

They found portions of viral RNA in the tissue up to 2 years after people were infected, though there was no evidence of reinfection. Those viral fragments were found in connective tissue where immune cells are, suggesting that the fragments caused the immune system to attack, according to the researchers. 

The UCSF team is running clinical trials to find out if monoclonal antibodies or antiviral drugs can remove the virus. 

The findings were presented in Denver this week at the Conference on Retroviruses and Opportunistic Infections.

A version of this article appeared on WebMD.com.

This transcript has been edited for clarity.

Hospital administrators and some department heads have been vocal about the potential for unions to affect both the attending-resident relationship and the ability for residents to directly discuss concerns and educational plans.

Critics feel that having a third party at the table, such as a union representative who isn’t as knowledgeable about the nuances of medical education, could complicate the decision-making process.

Sometimes, there are institution-specific issues as well. One example was at Loma Linda. They argued that unionization would go against their religious principles. They filed a lawsuit. That didn’t go through, and the residents won a few months later.

I know there’s always that one senior, older doctor who says, “Back in our day, we just worked, and we never complained.”

Look at the current situation that residents are facing now, with housing and rent prices and increasing costs of childcare. Sprinkle in some inflation, poor hospital staffing, increasing workload, and add in the fact that the average first-year resident salary in 2023 was around $64,000.

Now, if you look back to 2012, the average salary was around $55,000. If you adjust that for inflation, it would be around $75,000 today, which is more than what the average resident is getting paid.

Then, there are hospital administrators who say that the hospital does not have the money to meet these demands; meanwhile, hospital graduate medical education (GME) offices receive about $150,000 of Medicare funds per resident.

Obviously, there are additional costs when it comes to training and supporting residents. In general, unionizing freaks out the people handling all the cash.

There’s also the threat of a strike, which no hospital wants on their public record. A recent highly publicized event happened at New York’s Elmhurst Hospital, when 160 residents went on strike for 3 days until a deal was made.

Critics of unionizing also cite a particular study in JAMA, which included a survey of 5700 general surgery residents at 285 programs. It found that while unions helped with vacation time and housing stipends, the unions were not associated with improved burnout rates, suicidality, job satisfaction, duty hour violations, mistreatment, educational environment, or salary.

Now, granted, this isn’t the strongest study. It only sampled one group of residents, so I wouldn’t generalize these findings, but it’s still commonly cited by anti-union advocates.

Another potential downside, which is purely anecdotal because I can’t find any data to support this, is potential retaliation against residents or harm to the attending-resident relationship.

I’m an attending. I don’t really understand this one. I don’t exactly own stock in my hospital, nor am I making millions of dollars by siphoning GME money. I’m just trying to focus on educating and supporting my residents the best I can.

Dr. Patel is Clinical Instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons; Pediatric Hospitalist, Morgan Stanley Children’s Hospital of NewYork–Presbyterian, and Benioff Children’s Hospital, University of California San Francisco. He disclosed ties with Medumo Inc.

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

This transcript has been edited for clarity.

Hospital administrators and some department heads have been vocal about the potential for unions to affect both the attending-resident relationship and the ability for residents to directly discuss concerns and educational plans.

Critics feel that having a third party at the table, such as a union representative who isn’t as knowledgeable about the nuances of medical education, could complicate the decision-making process.

Sometimes, there are institution-specific issues as well. One example was at Loma Linda. They argued that unionization would go against their religious principles. They filed a lawsuit. That didn’t go through, and the residents won a few months later.

I know there’s always that one senior, older doctor who says, “Back in our day, we just worked, and we never complained.”

Look at the current situation that residents are facing now, with housing and rent prices and increasing costs of childcare. Sprinkle in some inflation, poor hospital staffing, increasing workload, and add in the fact that the average first-year resident salary in 2023 was around $64,000.

Now, if you look back to 2012, the average salary was around $55,000. If you adjust that for inflation, it would be around $75,000 today, which is more than what the average resident is getting paid.

Then, there are hospital administrators who say that the hospital does not have the money to meet these demands; meanwhile, hospital graduate medical education (GME) offices receive about $150,000 of Medicare funds per resident.

Obviously, there are additional costs when it comes to training and supporting residents. In general, unionizing freaks out the people handling all the cash.

There’s also the threat of a strike, which no hospital wants on their public record. A recent highly publicized event happened at New York’s Elmhurst Hospital, when 160 residents went on strike for 3 days until a deal was made.

Critics of unionizing also cite a particular study in JAMA, which included a survey of 5700 general surgery residents at 285 programs. It found that while unions helped with vacation time and housing stipends, the unions were not associated with improved burnout rates, suicidality, job satisfaction, duty hour violations, mistreatment, educational environment, or salary.

Now, granted, this isn’t the strongest study. It only sampled one group of residents, so I wouldn’t generalize these findings, but it’s still commonly cited by anti-union advocates.

Another potential downside, which is purely anecdotal because I can’t find any data to support this, is potential retaliation against residents or harm to the attending-resident relationship.

I’m an attending. I don’t really understand this one. I don’t exactly own stock in my hospital, nor am I making millions of dollars by siphoning GME money. I’m just trying to focus on educating and supporting my residents the best I can.

Dr. Patel is Clinical Instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons; Pediatric Hospitalist, Morgan Stanley Children’s Hospital of NewYork–Presbyterian, and Benioff Children’s Hospital, University of California San Francisco. He disclosed ties with Medumo Inc.

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

This transcript has been edited for clarity.

Hospital administrators and some department heads have been vocal about the potential for unions to affect both the attending-resident relationship and the ability for residents to directly discuss concerns and educational plans.

Critics feel that having a third party at the table, such as a union representative who isn’t as knowledgeable about the nuances of medical education, could complicate the decision-making process.

Sometimes, there are institution-specific issues as well. One example was at Loma Linda. They argued that unionization would go against their religious principles. They filed a lawsuit. That didn’t go through, and the residents won a few months later.

I know there’s always that one senior, older doctor who says, “Back in our day, we just worked, and we never complained.”

Look at the current situation that residents are facing now, with housing and rent prices and increasing costs of childcare. Sprinkle in some inflation, poor hospital staffing, increasing workload, and add in the fact that the average first-year resident salary in 2023 was around $64,000.

Now, if you look back to 2012, the average salary was around $55,000. If you adjust that for inflation, it would be around $75,000 today, which is more than what the average resident is getting paid.

Then, there are hospital administrators who say that the hospital does not have the money to meet these demands; meanwhile, hospital graduate medical education (GME) offices receive about $150,000 of Medicare funds per resident.

Obviously, there are additional costs when it comes to training and supporting residents. In general, unionizing freaks out the people handling all the cash.

There’s also the threat of a strike, which no hospital wants on their public record. A recent highly publicized event happened at New York’s Elmhurst Hospital, when 160 residents went on strike for 3 days until a deal was made.

Critics of unionizing also cite a particular study in JAMA, which included a survey of 5700 general surgery residents at 285 programs. It found that while unions helped with vacation time and housing stipends, the unions were not associated with improved burnout rates, suicidality, job satisfaction, duty hour violations, mistreatment, educational environment, or salary.

Now, granted, this isn’t the strongest study. It only sampled one group of residents, so I wouldn’t generalize these findings, but it’s still commonly cited by anti-union advocates.

Another potential downside, which is purely anecdotal because I can’t find any data to support this, is potential retaliation against residents or harm to the attending-resident relationship.

I’m an attending. I don’t really understand this one. I don’t exactly own stock in my hospital, nor am I making millions of dollars by siphoning GME money. I’m just trying to focus on educating and supporting my residents the best I can.

Dr. Patel is Clinical Instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons; Pediatric Hospitalist, Morgan Stanley Children’s Hospital of NewYork–Presbyterian, and Benioff Children’s Hospital, University of California San Francisco. He disclosed ties with Medumo Inc.

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

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

Lawmakers have added a provision to raise Medicare payments to clinicians to a $460 billion bipartisan package of federal spending bills that passed in the House on March 6 and is expected to be passed in the Senate and signed by President Biden before then end of March 8, but industry groups have criticized it as paltry.

Lawmakers often tweak Medicare policy by adding provisions to other kinds of legislation, including the spending bills Congress must pass to keep the federal government running.

Physicians’ groups and some lawmakers have long pressed Congress to change Medicare payment rules with little success, even as inflation has caused physicians’ expenses to rise. Doctors now face a 3.4% cut to Medicare reimbursements in 2024, which would be only partly mitigated by the recently announced provision.

The Medical Group Management Association (MGMA) said the proposed increase would total 1.68%. The increase, part of a bipartisan package of bills released by the House and Senate Appropriations committees on March 3, would apply to the budget for fiscal 2024, which began on October 1, 2023.

“We are deeply disappointed with Congress’ half-hearted attempt to remedy the devastating blow physician practices were dealt by the 2024 Medicare Physician Fee Schedule,” Anders Gilberg, senior vice president of MGMA, said in a statement. “Anything less than a full reversal of the 3.4% cut is appallingly inadequate.”

The American Medical Association said it was “extremely disappointed” that the boost only eased, but did not fully reverse, a deeper planned cut.

The American Academy of Family Physicians (AAFP) also expressed disappointment with the proposed increase.

“The AAFP has repeatedly told Congress that the 3.4% Medicare payment reduction that went into effect on January 1 is untenable for family physicians and threatens patients’ access to primary care,” the group said in a statement.

“While we appreciate the partial relief, family physicians continue to face an annual threat of payment cuts that are detrimental to practices and patients,” AAFP said.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

In the early days of the pandemic, before we really understood what COVID was, two specialties in the hospital had a foreboding sense that something was very strange about this virus. The first was the pulmonologists, who noticed the striking levels of hypoxemia — low oxygen in the blood — and the rapidity with which patients who had previously been stable would crash in the intensive care unit.

The second, and I mark myself among this group, were the nephrologists. The dialysis machines stopped working right. I remember rounding on patients in the hospital who were on dialysis for kidney failure in the setting of severe COVID infection and seeing clots forming on the dialysis filters. Some patients could barely get in a full treatment because the filters would clog so quickly.

We knew it was worse than flu because of the mortality rates, but these oddities made us realize that it was different too — not just a particularly nasty respiratory virus but one that had effects on the body that we hadn’t really seen before.

Centers for Disease Control and Prevention

Worldometer

Annals of Internal Medicine

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. WIlson

Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

In the early days of the pandemic, before we really understood what COVID was, two specialties in the hospital had a foreboding sense that something was very strange about this virus. The first was the pulmonologists, who noticed the striking levels of hypoxemia — low oxygen in the blood — and the rapidity with which patients who had previously been stable would crash in the intensive care unit.

The second, and I mark myself among this group, were the nephrologists. The dialysis machines stopped working right. I remember rounding on patients in the hospital who were on dialysis for kidney failure in the setting of severe COVID infection and seeing clots forming on the dialysis filters. Some patients could barely get in a full treatment because the filters would clog so quickly.

We knew it was worse than flu because of the mortality rates, but these oddities made us realize that it was different too — not just a particularly nasty respiratory virus but one that had effects on the body that we hadn’t really seen before.

Centers for Disease Control and Prevention

Worldometer

Annals of Internal Medicine

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. WIlson

Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

In the early days of the pandemic, before we really understood what COVID was, two specialties in the hospital had a foreboding sense that something was very strange about this virus. The first was the pulmonologists, who noticed the striking levels of hypoxemia — low oxygen in the blood — and the rapidity with which patients who had previously been stable would crash in the intensive care unit.

The second, and I mark myself among this group, were the nephrologists. The dialysis machines stopped working right. I remember rounding on patients in the hospital who were on dialysis for kidney failure in the setting of severe COVID infection and seeing clots forming on the dialysis filters. Some patients could barely get in a full treatment because the filters would clog so quickly.

We knew it was worse than flu because of the mortality rates, but these oddities made us realize that it was different too — not just a particularly nasty respiratory virus but one that had effects on the body that we hadn’t really seen before.

Centers for Disease Control and Prevention

Worldometer

Annals of Internal Medicine

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. WIlson

Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

When the world needed a COVID vaccine, leading HIV investigators answered the call to intervene in the coronavirus pandemic. Now, efforts to discover the world’s first HIV vaccine are revitalized.

“The body is capable of making antibodies to protect us from HIV,” says Yunda Huang, PhD, from the Fred Hutchinson Cancer Center in Seattle, Washington, who sat down with me before her talk today at the Conference on Retroviruses & Opportunistic Infections.

Dr. Huang spoke about the path forward for neutralizing antibody protection after the last attempt in a generation of HIV vaccine development ended in disappointment.

The past two decades marked the rise in HIV broadly neutralizing antibodies, with vaccine strategies to induce them. Promising advances include germline approaches, mRNA, and nanoparticle technologies.

The PrEP vaccine trial testing two experimental prevention regimens in Africa was stopped after investigators reported there is “little to no chance” the trial will show the vaccines are effective.
 

A Shape-Shifting Virus

HIV has been called the shape-shifting virus because it disguises itself so that even when people are able to make antibodies to it, the virus changes to escape.

But Dr. Huang and others are optimistic that an effective vaccine is still possible.

“We cannot and will not lose hope that the world will have an effective HIV vaccine that is accessible by all who need it, anywhere,” International AIDS Society (IAS) Executive Director Birgit Poniatowski said in a statement in December, when the trial was stopped.

HIV is a still persistent problem in the United States, according to the Centers for Disease Control and Prevention that reports it has affected an estimated 1.2 million people.

With new people infected every day around the globe, Dr. Huang says she feels a sense of urgency to help. “I think about all the people around the globe and the large number of young girls being hurt and I know our big pool of talent can intervene to change what we see happening.” 

Dr. Huang says the clinical trial failures we’ve seen so far will help guide next steps in HIV research as much as successes typically do.
 

Advances in the Field

With significant advances in protein nanoparticle science, mRNA technology, adjuvant development, and B-cell and antibody analyses, a new wave of clinical trials are on the way.

And with so many new approaches in the works, the HIV Vaccine Trials Network is retooling how it operates to navigate a burgeoning field and identify the most promising regimens.

A new Discovery Medicine Program will help the network assess new vaccine candidates. It will also aim to rule out others earlier on.

For COVID-19 and the flu, multimeric nanoparticles are an important alternative under investigation that could also be adapted for HIV.

Dr. Huang says she is particularly excited to watch the progress in cocktails of combination monoclonals. “I’ve been working in this field for 20 years now and there is a misconception that with pre-exposure prophylaxis, our job is done, but HIV is so far from away from being solved.”

But you just never know, Dr. Huang says. With new research, “we could bump on something at any point that changes everything.”

A version of this article appeared on Medscape.com.

When the world needed a COVID vaccine, leading HIV investigators answered the call to intervene in the coronavirus pandemic. Now, efforts to discover the world’s first HIV vaccine are revitalized.

“The body is capable of making antibodies to protect us from HIV,” says Yunda Huang, PhD, from the Fred Hutchinson Cancer Center in Seattle, Washington, who sat down with me before her talk today at the Conference on Retroviruses & Opportunistic Infections.

Dr. Huang spoke about the path forward for neutralizing antibody protection after the last attempt in a generation of HIV vaccine development ended in disappointment.

The past two decades marked the rise in HIV broadly neutralizing antibodies, with vaccine strategies to induce them. Promising advances include germline approaches, mRNA, and nanoparticle technologies.

The PrEP vaccine trial testing two experimental prevention regimens in Africa was stopped after investigators reported there is “little to no chance” the trial will show the vaccines are effective.
 

A Shape-Shifting Virus

HIV has been called the shape-shifting virus because it disguises itself so that even when people are able to make antibodies to it, the virus changes to escape.

But Dr. Huang and others are optimistic that an effective vaccine is still possible.

“We cannot and will not lose hope that the world will have an effective HIV vaccine that is accessible by all who need it, anywhere,” International AIDS Society (IAS) Executive Director Birgit Poniatowski said in a statement in December, when the trial was stopped.

HIV is a still persistent problem in the United States, according to the Centers for Disease Control and Prevention that reports it has affected an estimated 1.2 million people.

With new people infected every day around the globe, Dr. Huang says she feels a sense of urgency to help. “I think about all the people around the globe and the large number of young girls being hurt and I know our big pool of talent can intervene to change what we see happening.” 

Dr. Huang says the clinical trial failures we’ve seen so far will help guide next steps in HIV research as much as successes typically do.
 

Advances in the Field

With significant advances in protein nanoparticle science, mRNA technology, adjuvant development, and B-cell and antibody analyses, a new wave of clinical trials are on the way.

And with so many new approaches in the works, the HIV Vaccine Trials Network is retooling how it operates to navigate a burgeoning field and identify the most promising regimens.

A new Discovery Medicine Program will help the network assess new vaccine candidates. It will also aim to rule out others earlier on.

For COVID-19 and the flu, multimeric nanoparticles are an important alternative under investigation that could also be adapted for HIV.

Dr. Huang says she is particularly excited to watch the progress in cocktails of combination monoclonals. “I’ve been working in this field for 20 years now and there is a misconception that with pre-exposure prophylaxis, our job is done, but HIV is so far from away from being solved.”

But you just never know, Dr. Huang says. With new research, “we could bump on something at any point that changes everything.”

A version of this article appeared on Medscape.com.

When the world needed a COVID vaccine, leading HIV investigators answered the call to intervene in the coronavirus pandemic. Now, efforts to discover the world’s first HIV vaccine are revitalized.

“The body is capable of making antibodies to protect us from HIV,” says Yunda Huang, PhD, from the Fred Hutchinson Cancer Center in Seattle, Washington, who sat down with me before her talk today at the Conference on Retroviruses & Opportunistic Infections.

Dr. Huang spoke about the path forward for neutralizing antibody protection after the last attempt in a generation of HIV vaccine development ended in disappointment.

The past two decades marked the rise in HIV broadly neutralizing antibodies, with vaccine strategies to induce them. Promising advances include germline approaches, mRNA, and nanoparticle technologies.

The PrEP vaccine trial testing two experimental prevention regimens in Africa was stopped after investigators reported there is “little to no chance” the trial will show the vaccines are effective.
 

A Shape-Shifting Virus

HIV has been called the shape-shifting virus because it disguises itself so that even when people are able to make antibodies to it, the virus changes to escape.

But Dr. Huang and others are optimistic that an effective vaccine is still possible.

“We cannot and will not lose hope that the world will have an effective HIV vaccine that is accessible by all who need it, anywhere,” International AIDS Society (IAS) Executive Director Birgit Poniatowski said in a statement in December, when the trial was stopped.

HIV is a still persistent problem in the United States, according to the Centers for Disease Control and Prevention that reports it has affected an estimated 1.2 million people.

With new people infected every day around the globe, Dr. Huang says she feels a sense of urgency to help. “I think about all the people around the globe and the large number of young girls being hurt and I know our big pool of talent can intervene to change what we see happening.” 

Dr. Huang says the clinical trial failures we’ve seen so far will help guide next steps in HIV research as much as successes typically do.
 

Advances in the Field

With significant advances in protein nanoparticle science, mRNA technology, adjuvant development, and B-cell and antibody analyses, a new wave of clinical trials are on the way.

And with so many new approaches in the works, the HIV Vaccine Trials Network is retooling how it operates to navigate a burgeoning field and identify the most promising regimens.

A new Discovery Medicine Program will help the network assess new vaccine candidates. It will also aim to rule out others earlier on.

For COVID-19 and the flu, multimeric nanoparticles are an important alternative under investigation that could also be adapted for HIV.

Dr. Huang says she is particularly excited to watch the progress in cocktails of combination monoclonals. “I’ve been working in this field for 20 years now and there is a misconception that with pre-exposure prophylaxis, our job is done, but HIV is so far from away from being solved.”

But you just never know, Dr. Huang says. With new research, “we could bump on something at any point that changes everything.”

A version of this article appeared on Medscape.com.

Syphilis and chlamydia infections were reduced by half among men who have sex with men and transgender women 1 year after San Francisco rolled out doxycycline postexposure prophylaxis (doxy-PEP), according to data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) this week.

After a clinical trial showed that doxy-PEP taken after sex reduced the chance of acquiring syphilis, gonorrhea, and chlamydia by about two-thirds, the San Francisco Department of Public Health released the first guidelines in the country in October 2022. 

The guidelines recommend that a person take two 100-mg pills of doxycycline ideally in the 24 hours after but no more than 72 hours after condomless sex. So far, more than 3700 people in San Francisco have been prescribed doxy-PEP, reports Stephanie Cohen, MD, director of HIV and sexually transmitted infection (STI) prevention in the Disease Prevention and Control Branch of Public Health.

Dr. Cohen and her colleagues spent a year monitoring the uptake of doxy-PEP and used a computer model to predict what the rates of sexually transmitted infection would have been without doxy-PEP. 

In November 2023, 13 months after the guidelines were introduced, they found that monthly chlamydia and early syphilis infections were 50% and 51% lower, respectively, than what was predicted by the model.
 

Fewer Infections

The drop in infections is having a tangible effect on patients in San Francisco, and many clinicians are noting that they are seeing far fewer positive tests. “The results that we’re seeing on a city-wide level are absolutely being experienced by individual providers and patients,” Dr. Cohen said.

However, the analysis showed no effect on rates of gonorrhea. It’s not clear why, although Dr. Cohen points out that doxy-PEP was less effective against gonorrhea in the clinical trial. And “there could be other factors in play,” she added. “Adherence might matter more, or it could be affected by the prevalence of tetracycline resistance in the community.”

With rates of STIs, particularly syphilis, quickly rising in recent years, healthcare providers have been scrambling to find effective interventions. So far, doxy-PEP has shown the most promise. “We’ve known for a while that all of the strategies we’ve been employing don’t seem to be working,” noted Chase Cannon, MD, an infectious disease specialist at the University of Washington in Seattle. “That’s why doxy-PEP is important. We haven’t had anything that can deflect the curve in a long time.”
 

What About the Side Effects?

Some concerns remain, however, about the widespread prophylactic use of antibiotics. There are no long-term safety data on the potential side effects of doxy-PEP, and there is still a lot of stigma around interventions that allow people to have sex the way they want, said Dr. Cannon.

But perhaps, the biggest concern is that doxy-PEP could contribute to antibiotic resistance. Those fears are not misplaced, Dr. Cannon added. The results of one study, presented in a poster at CROI, showed that stool samples from people prescribed doxy-PEP had elevated levels of bacterial genes that can confer resistance to tetracyclines, the class of antibiotics to which doxycycline belongs. There was no change in resistance to other classes of antibiotics and no difference in bacterial diversity over the 6 months of the study.

Dr. Cannon cautioned, however, that we can’t extrapolate these results to clinical outcomes. “We can look for signals [of resistance], but we don’t know if this means someone will fail therapy for chlamydia or syphilis,” he said.

There are still many challenges to overcome before doxy-PEP can be rolled out widely, Dr. Cohen explained. There is a lack of consensus among healthcare professionals about who should be offered doxy-PEP. The clinical trial results and the San Fransisco guidelines only apply to men who have sex with men and to transgender women.

Some clinicians argue that the intervention should be provided to a broader population, whereas others want to see more research to ensure that unnecessary antibiotic use is minimized.

So far just one study has tested doxy-PEP in another population — in women in Kenya — and it was found to not be effective. But the data suggest that adherence to the protocol was poor in that study, so the results may not be reliable, Dr. Cohen said.

“We need effective prevention tools for all genders, especially cis women who bear most of the morbidity,” she said. “It stands to reason that this should work for them, but without high-quality evidence, there is insufficient information to make a recommendation for cis women.”

The US Centers for Disease Control and Prevention is currently reviewing public and expert comments and refining final guidelines for release in the coming months, which should alleviate some of the uncertainty. “Many providers are waiting for that guidance before they will feel confident moving forward,” Dr. Cohen noted.

But despite the risks and uncertainty, doxy-PEP looks set to be a major part of the fight against STIs going forward. “Doxy-PEP is essential for us as a nation to be dealing with the syphilis epidemic,” Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Disease, said in a video introduction to CROI.

A version of this article appeared on Medscape.com.

Syphilis and chlamydia infections were reduced by half among men who have sex with men and transgender women 1 year after San Francisco rolled out doxycycline postexposure prophylaxis (doxy-PEP), according to data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) this week.

After a clinical trial showed that doxy-PEP taken after sex reduced the chance of acquiring syphilis, gonorrhea, and chlamydia by about two-thirds, the San Francisco Department of Public Health released the first guidelines in the country in October 2022. 

The guidelines recommend that a person take two 100-mg pills of doxycycline ideally in the 24 hours after but no more than 72 hours after condomless sex. So far, more than 3700 people in San Francisco have been prescribed doxy-PEP, reports Stephanie Cohen, MD, director of HIV and sexually transmitted infection (STI) prevention in the Disease Prevention and Control Branch of Public Health.

Dr. Cohen and her colleagues spent a year monitoring the uptake of doxy-PEP and used a computer model to predict what the rates of sexually transmitted infection would have been without doxy-PEP. 

In November 2023, 13 months after the guidelines were introduced, they found that monthly chlamydia and early syphilis infections were 50% and 51% lower, respectively, than what was predicted by the model.
 

Fewer Infections

The drop in infections is having a tangible effect on patients in San Francisco, and many clinicians are noting that they are seeing far fewer positive tests. “The results that we’re seeing on a city-wide level are absolutely being experienced by individual providers and patients,” Dr. Cohen said.

However, the analysis showed no effect on rates of gonorrhea. It’s not clear why, although Dr. Cohen points out that doxy-PEP was less effective against gonorrhea in the clinical trial. And “there could be other factors in play,” she added. “Adherence might matter more, or it could be affected by the prevalence of tetracycline resistance in the community.”

With rates of STIs, particularly syphilis, quickly rising in recent years, healthcare providers have been scrambling to find effective interventions. So far, doxy-PEP has shown the most promise. “We’ve known for a while that all of the strategies we’ve been employing don’t seem to be working,” noted Chase Cannon, MD, an infectious disease specialist at the University of Washington in Seattle. “That’s why doxy-PEP is important. We haven’t had anything that can deflect the curve in a long time.”
 

What About the Side Effects?

Some concerns remain, however, about the widespread prophylactic use of antibiotics. There are no long-term safety data on the potential side effects of doxy-PEP, and there is still a lot of stigma around interventions that allow people to have sex the way they want, said Dr. Cannon.

But perhaps, the biggest concern is that doxy-PEP could contribute to antibiotic resistance. Those fears are not misplaced, Dr. Cannon added. The results of one study, presented in a poster at CROI, showed that stool samples from people prescribed doxy-PEP had elevated levels of bacterial genes that can confer resistance to tetracyclines, the class of antibiotics to which doxycycline belongs. There was no change in resistance to other classes of antibiotics and no difference in bacterial diversity over the 6 months of the study.

Dr. Cannon cautioned, however, that we can’t extrapolate these results to clinical outcomes. “We can look for signals [of resistance], but we don’t know if this means someone will fail therapy for chlamydia or syphilis,” he said.

There are still many challenges to overcome before doxy-PEP can be rolled out widely, Dr. Cohen explained. There is a lack of consensus among healthcare professionals about who should be offered doxy-PEP. The clinical trial results and the San Fransisco guidelines only apply to men who have sex with men and to transgender women.

Some clinicians argue that the intervention should be provided to a broader population, whereas others want to see more research to ensure that unnecessary antibiotic use is minimized.

So far just one study has tested doxy-PEP in another population — in women in Kenya — and it was found to not be effective. But the data suggest that adherence to the protocol was poor in that study, so the results may not be reliable, Dr. Cohen said.

“We need effective prevention tools for all genders, especially cis women who bear most of the morbidity,” she said. “It stands to reason that this should work for them, but without high-quality evidence, there is insufficient information to make a recommendation for cis women.”

The US Centers for Disease Control and Prevention is currently reviewing public and expert comments and refining final guidelines for release in the coming months, which should alleviate some of the uncertainty. “Many providers are waiting for that guidance before they will feel confident moving forward,” Dr. Cohen noted.

But despite the risks and uncertainty, doxy-PEP looks set to be a major part of the fight against STIs going forward. “Doxy-PEP is essential for us as a nation to be dealing with the syphilis epidemic,” Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Disease, said in a video introduction to CROI.

A version of this article appeared on Medscape.com.

Syphilis and chlamydia infections were reduced by half among men who have sex with men and transgender women 1 year after San Francisco rolled out doxycycline postexposure prophylaxis (doxy-PEP), according to data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) this week.

After a clinical trial showed that doxy-PEP taken after sex reduced the chance of acquiring syphilis, gonorrhea, and chlamydia by about two-thirds, the San Francisco Department of Public Health released the first guidelines in the country in October 2022. 

The guidelines recommend that a person take two 100-mg pills of doxycycline ideally in the 24 hours after but no more than 72 hours after condomless sex. So far, more than 3700 people in San Francisco have been prescribed doxy-PEP, reports Stephanie Cohen, MD, director of HIV and sexually transmitted infection (STI) prevention in the Disease Prevention and Control Branch of Public Health.

Dr. Cohen and her colleagues spent a year monitoring the uptake of doxy-PEP and used a computer model to predict what the rates of sexually transmitted infection would have been without doxy-PEP. 

In November 2023, 13 months after the guidelines were introduced, they found that monthly chlamydia and early syphilis infections were 50% and 51% lower, respectively, than what was predicted by the model.
 

Fewer Infections

The drop in infections is having a tangible effect on patients in San Francisco, and many clinicians are noting that they are seeing far fewer positive tests. “The results that we’re seeing on a city-wide level are absolutely being experienced by individual providers and patients,” Dr. Cohen said.

However, the analysis showed no effect on rates of gonorrhea. It’s not clear why, although Dr. Cohen points out that doxy-PEP was less effective against gonorrhea in the clinical trial. And “there could be other factors in play,” she added. “Adherence might matter more, or it could be affected by the prevalence of tetracycline resistance in the community.”

With rates of STIs, particularly syphilis, quickly rising in recent years, healthcare providers have been scrambling to find effective interventions. So far, doxy-PEP has shown the most promise. “We’ve known for a while that all of the strategies we’ve been employing don’t seem to be working,” noted Chase Cannon, MD, an infectious disease specialist at the University of Washington in Seattle. “That’s why doxy-PEP is important. We haven’t had anything that can deflect the curve in a long time.”
 

What About the Side Effects?

Some concerns remain, however, about the widespread prophylactic use of antibiotics. There are no long-term safety data on the potential side effects of doxy-PEP, and there is still a lot of stigma around interventions that allow people to have sex the way they want, said Dr. Cannon.

But perhaps, the biggest concern is that doxy-PEP could contribute to antibiotic resistance. Those fears are not misplaced, Dr. Cannon added. The results of one study, presented in a poster at CROI, showed that stool samples from people prescribed doxy-PEP had elevated levels of bacterial genes that can confer resistance to tetracyclines, the class of antibiotics to which doxycycline belongs. There was no change in resistance to other classes of antibiotics and no difference in bacterial diversity over the 6 months of the study.

Dr. Cannon cautioned, however, that we can’t extrapolate these results to clinical outcomes. “We can look for signals [of resistance], but we don’t know if this means someone will fail therapy for chlamydia or syphilis,” he said.

There are still many challenges to overcome before doxy-PEP can be rolled out widely, Dr. Cohen explained. There is a lack of consensus among healthcare professionals about who should be offered doxy-PEP. The clinical trial results and the San Fransisco guidelines only apply to men who have sex with men and to transgender women.

Some clinicians argue that the intervention should be provided to a broader population, whereas others want to see more research to ensure that unnecessary antibiotic use is minimized.

So far just one study has tested doxy-PEP in another population — in women in Kenya — and it was found to not be effective. But the data suggest that adherence to the protocol was poor in that study, so the results may not be reliable, Dr. Cohen said.

“We need effective prevention tools for all genders, especially cis women who bear most of the morbidity,” she said. “It stands to reason that this should work for them, but without high-quality evidence, there is insufficient information to make a recommendation for cis women.”

The US Centers for Disease Control and Prevention is currently reviewing public and expert comments and refining final guidelines for release in the coming months, which should alleviate some of the uncertainty. “Many providers are waiting for that guidance before they will feel confident moving forward,” Dr. Cohen noted.

But despite the risks and uncertainty, doxy-PEP looks set to be a major part of the fight against STIs going forward. “Doxy-PEP is essential for us as a nation to be dealing with the syphilis epidemic,” Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Disease, said in a video introduction to CROI.

A version of this article appeared on Medscape.com.