Conference Coverage

Improved molecular characterization of mixed glioneuronal and neuronal tumors is driving the World Health Organization to update its classification system for pediatric brain tumors, and that will have far-reaching implications for how clinicians diagnose and manage these rare and often debilitating malignancies, a leading European researcher reported at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“These pediatric neuronal/glioneuronal tumors are quite heterogeneous in terms of the number of different tumors and subclasses of tumors going into these groups, but they have some molecular features in common,” said David T.W. Jones, PhD, of Hopp Children’s Cancer Center in Heidelberg, Germany. “Together they represent quite a sizable portion of all childhood brain tumors, so it’s important to recognize and understand them.”

Dr. Jones noted that updated WHO classifications would add six new descriptions to the category of mixed glioneuronal tumors and one to the list of neuronal tumors. A working group of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy, known as cIMPACT-NOW, has recommended the expanded classifications for central nervous system tumors.

“The molecular understandings of pediatric neuro-glial tumors are critical in their management,” Roger Packer, MD, senior vice president of the Center for Neuroscience and Behavioral Health at Children’s National in Washington, said in an interview, especially as treatments targeting specific molecular structures emerge. “For those with tumors not amenable to safe, total resections, there’s little evidence that radiation or chemotherapy are effective, and molecular-targeted therapy, guided by the molecular genetic composition, increases the safe use of these new agents.”

Dr. Jones noted that “as a minimum” molecular diagnostics of pediatric low-grade glioneuronal and neuronal tumors should include a BRAF gene mutation and fusion status, as well as FGFR1 mutation plus fusion or rearrangement status.

“Ideally,” he added, “it should also have a broader copy number profile, whether that’s based on sequencing or SNP arrays or DNA methylation rate, a global DNA methylation profile to get those global molecular patterns, and also wider gene and RNA sequence to pick up some of those rarer alterations that may not be covered by targeted BRAF and FGFR1 mutations.”

The updated tumor classification will evolve to include novel tumor classes, as well as links or overlaps between the tumor classes and their characteristic underlying kinetic alterations, he noted. “Some of these profiling measures will actually be required to generate a fully WHO-compatible pathological diagnosis,” Dr. Jones said.

“This group of tumors are now just better molecularly characterized than it was 5 years ago, so in the last few years we’ve really made tremendous progress in understanding what alterations are driving some of these tumors,” he said. “That knowledge is now providing a basis for improved diagnosis and also for starting to plan more targeted treatment strategies.”

But, he added, there’s still a lot to learn about how these oncogenic mechanisms drive tumor pathogenesis. “What is the clinical costs when we really start getting down into defining these distinct molecular groups?” he said. “What are their different responses to treatment depending on different levels, where the MEKi [mitogen-activated protein kinase inhibitor] pathway might be activated and, for example, response to treatment of different subclasses of one tumor?”

Large, collaborative clinical studies will be needed to get those answers, he said.

“There are certainly some therapeutic opportunities arising in this group of tumors now, but in order to really translate those into a clinical benefit, we’re really going to need some careful planning of international studies because of the relative rarity of some of these groups,” he said.

Dr. Jones has no relevant financial relationships to disclose.

Improved molecular characterization of mixed glioneuronal and neuronal tumors is driving the World Health Organization to update its classification system for pediatric brain tumors, and that will have far-reaching implications for how clinicians diagnose and manage these rare and often debilitating malignancies, a leading European researcher reported at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“These pediatric neuronal/glioneuronal tumors are quite heterogeneous in terms of the number of different tumors and subclasses of tumors going into these groups, but they have some molecular features in common,” said David T.W. Jones, PhD, of Hopp Children’s Cancer Center in Heidelberg, Germany. “Together they represent quite a sizable portion of all childhood brain tumors, so it’s important to recognize and understand them.”

Dr. Jones noted that updated WHO classifications would add six new descriptions to the category of mixed glioneuronal tumors and one to the list of neuronal tumors. A working group of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy, known as cIMPACT-NOW, has recommended the expanded classifications for central nervous system tumors.

“The molecular understandings of pediatric neuro-glial tumors are critical in their management,” Roger Packer, MD, senior vice president of the Center for Neuroscience and Behavioral Health at Children’s National in Washington, said in an interview, especially as treatments targeting specific molecular structures emerge. “For those with tumors not amenable to safe, total resections, there’s little evidence that radiation or chemotherapy are effective, and molecular-targeted therapy, guided by the molecular genetic composition, increases the safe use of these new agents.”

Dr. Jones noted that “as a minimum” molecular diagnostics of pediatric low-grade glioneuronal and neuronal tumors should include a BRAF gene mutation and fusion status, as well as FGFR1 mutation plus fusion or rearrangement status.

“Ideally,” he added, “it should also have a broader copy number profile, whether that’s based on sequencing or SNP arrays or DNA methylation rate, a global DNA methylation profile to get those global molecular patterns, and also wider gene and RNA sequence to pick up some of those rarer alterations that may not be covered by targeted BRAF and FGFR1 mutations.”

The updated tumor classification will evolve to include novel tumor classes, as well as links or overlaps between the tumor classes and their characteristic underlying kinetic alterations, he noted. “Some of these profiling measures will actually be required to generate a fully WHO-compatible pathological diagnosis,” Dr. Jones said.

“This group of tumors are now just better molecularly characterized than it was 5 years ago, so in the last few years we’ve really made tremendous progress in understanding what alterations are driving some of these tumors,” he said. “That knowledge is now providing a basis for improved diagnosis and also for starting to plan more targeted treatment strategies.”

But, he added, there’s still a lot to learn about how these oncogenic mechanisms drive tumor pathogenesis. “What is the clinical costs when we really start getting down into defining these distinct molecular groups?” he said. “What are their different responses to treatment depending on different levels, where the MEKi [mitogen-activated protein kinase inhibitor] pathway might be activated and, for example, response to treatment of different subclasses of one tumor?”

Large, collaborative clinical studies will be needed to get those answers, he said.

“There are certainly some therapeutic opportunities arising in this group of tumors now, but in order to really translate those into a clinical benefit, we’re really going to need some careful planning of international studies because of the relative rarity of some of these groups,” he said.

Dr. Jones has no relevant financial relationships to disclose.

Improved molecular characterization of mixed glioneuronal and neuronal tumors is driving the World Health Organization to update its classification system for pediatric brain tumors, and that will have far-reaching implications for how clinicians diagnose and manage these rare and often debilitating malignancies, a leading European researcher reported at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year.

“These pediatric neuronal/glioneuronal tumors are quite heterogeneous in terms of the number of different tumors and subclasses of tumors going into these groups, but they have some molecular features in common,” said David T.W. Jones, PhD, of Hopp Children’s Cancer Center in Heidelberg, Germany. “Together they represent quite a sizable portion of all childhood brain tumors, so it’s important to recognize and understand them.”

Dr. Jones noted that updated WHO classifications would add six new descriptions to the category of mixed glioneuronal tumors and one to the list of neuronal tumors. A working group of the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy, known as cIMPACT-NOW, has recommended the expanded classifications for central nervous system tumors.

“The molecular understandings of pediatric neuro-glial tumors are critical in their management,” Roger Packer, MD, senior vice president of the Center for Neuroscience and Behavioral Health at Children’s National in Washington, said in an interview, especially as treatments targeting specific molecular structures emerge. “For those with tumors not amenable to safe, total resections, there’s little evidence that radiation or chemotherapy are effective, and molecular-targeted therapy, guided by the molecular genetic composition, increases the safe use of these new agents.”

Dr. Jones noted that “as a minimum” molecular diagnostics of pediatric low-grade glioneuronal and neuronal tumors should include a BRAF gene mutation and fusion status, as well as FGFR1 mutation plus fusion or rearrangement status.

“Ideally,” he added, “it should also have a broader copy number profile, whether that’s based on sequencing or SNP arrays or DNA methylation rate, a global DNA methylation profile to get those global molecular patterns, and also wider gene and RNA sequence to pick up some of those rarer alterations that may not be covered by targeted BRAF and FGFR1 mutations.”

The updated tumor classification will evolve to include novel tumor classes, as well as links or overlaps between the tumor classes and their characteristic underlying kinetic alterations, he noted. “Some of these profiling measures will actually be required to generate a fully WHO-compatible pathological diagnosis,” Dr. Jones said.

“This group of tumors are now just better molecularly characterized than it was 5 years ago, so in the last few years we’ve really made tremendous progress in understanding what alterations are driving some of these tumors,” he said. “That knowledge is now providing a basis for improved diagnosis and also for starting to plan more targeted treatment strategies.”

But, he added, there’s still a lot to learn about how these oncogenic mechanisms drive tumor pathogenesis. “What is the clinical costs when we really start getting down into defining these distinct molecular groups?” he said. “What are their different responses to treatment depending on different levels, where the MEKi [mitogen-activated protein kinase inhibitor] pathway might be activated and, for example, response to treatment of different subclasses of one tumor?”

Large, collaborative clinical studies will be needed to get those answers, he said.

“There are certainly some therapeutic opportunities arising in this group of tumors now, but in order to really translate those into a clinical benefit, we’re really going to need some careful planning of international studies because of the relative rarity of some of these groups,” he said.

Dr. Jones has no relevant financial relationships to disclose.

Acute flaccid myelitis (AFM), a polio-like neuroinfectious disorder, is misdiagnosed in the majority of cases, and that can result in loss of valuable time to admit patients and begin treatment to get ahead of the virus that may cause the disease.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Leslie H. Hayes, MD, of Boston Children’s Hospital presented findings of a retrospective case series from 13 institutions in the United States and Canada that determined 78% of patients eventually found to have AFM were initially misdiagnosed. About 62% were given an alternate diagnosis or multiple diagnoses, and 60% did not get a referral for further care or evaluation. The study included 175 children aged 18 years and younger when symptoms first appeared from 2014 to 2018 and who met the Centers for Disease Control and Prevention case definition of AFM.

“As it becomes more evident that AFM outbreaks are driven by enterovirus infections, treatments targeting the viral infection are likely to be most effective very early in the course of disease, necessitating a precise and early diagnosis,” Dr. Hayes said. “Thus awareness is needed to help recognize the signs of symptoms of AFM, particularly among frontline clinicians.”

One reason for misdiagnosis is that AFM has features that overlap with other neuroinflammatory disorders, she said. “In many cases the patients are misdiagnosed as having benign or self-limiting processes that would not prompt the same monitoring and level of care.”

Numbness and prodromal illnesses were associated with misdiagnosis, she said, but otherwise most presenting symptoms were similar between the misdiagnosed and correctly diagnosed patients.

Neurologic disorders with similar features to AFM that the study identified were Guillain-Barré syndrome, spinal cord pathologies such as transverse myelitis, brain pathologies including acute disseminating encephalomyelitis, acute inclusion body encephalitis and stroke, and other neuroinflammatory conditions.

“There were also many patients diagnosed as having processes that in many cases would not prompt inpatient admission, would not involve neurology consultation, and would not be treated in a similar fashion to AFM,” Dr. Hayes said.

Those diagnoses included plexopathy, neuritis, Bell’s palsy, meningoencephalitis, nonspecific infectious illness or parainfectious autoimmune disease, or musculoskeletal problems including toxic or transient synovitis, myositis, fracture or sprain, or torticollis.

“We identified preceding illness and numbness as two features associated with misdiagnosis,” Dr. Hayes said.

“We evaluated illness severity by evaluating the need for invasive and noninvasive ventilation and found that, while not statistically significant, misdiagnosed patients had a trend toward higher need for such respiratory support,” she noted. Specifically, 31.6% of misdiagnosed patients required noninvasive ventilation versus 15.8% of promptly diagnosed patients (P = .06).

Dr. Hayes characterized the rates of ICU admissions between the two groups as not statistically significant: 52.5% and 36.8% for the misdiagnosed and promptly diagnosed groups, respectively (P = .1).

Both groups of patients received intravenous immunoglobulin in similar rates (77.9% and 81.6%, respectively, P = .63), but the misdiagnosed patients were much more likely to receive steroids, 68.2% versus 44.7% (P = .008). That’s likely because steroids are the standard treatment for the neuroinflammatory disorders that they were misdiagnosed with, Dr. Hayes said.

Timely diagnosis and treatment was more of an issue for the misdiagnosed patients; their diagnosis was made on average 5 days after the onset of symptoms versus 3 days (P < .001). “We found that time to treatment, particularly time to IVIg, was significantly longer in the misdiagnosed group,” Dr. Hayes said, at 5 versus 2 days (P < .001).

Dr. Hayes has no relevant financial relationships to disclose.

Acute flaccid myelitis (AFM), a polio-like neuroinfectious disorder, is misdiagnosed in the majority of cases, and that can result in loss of valuable time to admit patients and begin treatment to get ahead of the virus that may cause the disease.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Leslie H. Hayes, MD, of Boston Children’s Hospital presented findings of a retrospective case series from 13 institutions in the United States and Canada that determined 78% of patients eventually found to have AFM were initially misdiagnosed. About 62% were given an alternate diagnosis or multiple diagnoses, and 60% did not get a referral for further care or evaluation. The study included 175 children aged 18 years and younger when symptoms first appeared from 2014 to 2018 and who met the Centers for Disease Control and Prevention case definition of AFM.

“As it becomes more evident that AFM outbreaks are driven by enterovirus infections, treatments targeting the viral infection are likely to be most effective very early in the course of disease, necessitating a precise and early diagnosis,” Dr. Hayes said. “Thus awareness is needed to help recognize the signs of symptoms of AFM, particularly among frontline clinicians.”

One reason for misdiagnosis is that AFM has features that overlap with other neuroinflammatory disorders, she said. “In many cases the patients are misdiagnosed as having benign or self-limiting processes that would not prompt the same monitoring and level of care.”

Numbness and prodromal illnesses were associated with misdiagnosis, she said, but otherwise most presenting symptoms were similar between the misdiagnosed and correctly diagnosed patients.

Neurologic disorders with similar features to AFM that the study identified were Guillain-Barré syndrome, spinal cord pathologies such as transverse myelitis, brain pathologies including acute disseminating encephalomyelitis, acute inclusion body encephalitis and stroke, and other neuroinflammatory conditions.

“There were also many patients diagnosed as having processes that in many cases would not prompt inpatient admission, would not involve neurology consultation, and would not be treated in a similar fashion to AFM,” Dr. Hayes said.

Those diagnoses included plexopathy, neuritis, Bell’s palsy, meningoencephalitis, nonspecific infectious illness or parainfectious autoimmune disease, or musculoskeletal problems including toxic or transient synovitis, myositis, fracture or sprain, or torticollis.

“We identified preceding illness and numbness as two features associated with misdiagnosis,” Dr. Hayes said.

“We evaluated illness severity by evaluating the need for invasive and noninvasive ventilation and found that, while not statistically significant, misdiagnosed patients had a trend toward higher need for such respiratory support,” she noted. Specifically, 31.6% of misdiagnosed patients required noninvasive ventilation versus 15.8% of promptly diagnosed patients (P = .06).

Dr. Hayes characterized the rates of ICU admissions between the two groups as not statistically significant: 52.5% and 36.8% for the misdiagnosed and promptly diagnosed groups, respectively (P = .1).

Both groups of patients received intravenous immunoglobulin in similar rates (77.9% and 81.6%, respectively, P = .63), but the misdiagnosed patients were much more likely to receive steroids, 68.2% versus 44.7% (P = .008). That’s likely because steroids are the standard treatment for the neuroinflammatory disorders that they were misdiagnosed with, Dr. Hayes said.

Timely diagnosis and treatment was more of an issue for the misdiagnosed patients; their diagnosis was made on average 5 days after the onset of symptoms versus 3 days (P < .001). “We found that time to treatment, particularly time to IVIg, was significantly longer in the misdiagnosed group,” Dr. Hayes said, at 5 versus 2 days (P < .001).

Dr. Hayes has no relevant financial relationships to disclose.

Acute flaccid myelitis (AFM), a polio-like neuroinfectious disorder, is misdiagnosed in the majority of cases, and that can result in loss of valuable time to admit patients and begin treatment to get ahead of the virus that may cause the disease.

At the 2020 CNS-ICNA Conjoint Meeting, held virtually this year, Leslie H. Hayes, MD, of Boston Children’s Hospital presented findings of a retrospective case series from 13 institutions in the United States and Canada that determined 78% of patients eventually found to have AFM were initially misdiagnosed. About 62% were given an alternate diagnosis or multiple diagnoses, and 60% did not get a referral for further care or evaluation. The study included 175 children aged 18 years and younger when symptoms first appeared from 2014 to 2018 and who met the Centers for Disease Control and Prevention case definition of AFM.

“As it becomes more evident that AFM outbreaks are driven by enterovirus infections, treatments targeting the viral infection are likely to be most effective very early in the course of disease, necessitating a precise and early diagnosis,” Dr. Hayes said. “Thus awareness is needed to help recognize the signs of symptoms of AFM, particularly among frontline clinicians.”

One reason for misdiagnosis is that AFM has features that overlap with other neuroinflammatory disorders, she said. “In many cases the patients are misdiagnosed as having benign or self-limiting processes that would not prompt the same monitoring and level of care.”

Numbness and prodromal illnesses were associated with misdiagnosis, she said, but otherwise most presenting symptoms were similar between the misdiagnosed and correctly diagnosed patients.

Neurologic disorders with similar features to AFM that the study identified were Guillain-Barré syndrome, spinal cord pathologies such as transverse myelitis, brain pathologies including acute disseminating encephalomyelitis, acute inclusion body encephalitis and stroke, and other neuroinflammatory conditions.

“There were also many patients diagnosed as having processes that in many cases would not prompt inpatient admission, would not involve neurology consultation, and would not be treated in a similar fashion to AFM,” Dr. Hayes said.

Those diagnoses included plexopathy, neuritis, Bell’s palsy, meningoencephalitis, nonspecific infectious illness or parainfectious autoimmune disease, or musculoskeletal problems including toxic or transient synovitis, myositis, fracture or sprain, or torticollis.

“We identified preceding illness and numbness as two features associated with misdiagnosis,” Dr. Hayes said.

“We evaluated illness severity by evaluating the need for invasive and noninvasive ventilation and found that, while not statistically significant, misdiagnosed patients had a trend toward higher need for such respiratory support,” she noted. Specifically, 31.6% of misdiagnosed patients required noninvasive ventilation versus 15.8% of promptly diagnosed patients (P = .06).

Dr. Hayes characterized the rates of ICU admissions between the two groups as not statistically significant: 52.5% and 36.8% for the misdiagnosed and promptly diagnosed groups, respectively (P = .1).

Both groups of patients received intravenous immunoglobulin in similar rates (77.9% and 81.6%, respectively, P = .63), but the misdiagnosed patients were much more likely to receive steroids, 68.2% versus 44.7% (P = .008). That’s likely because steroids are the standard treatment for the neuroinflammatory disorders that they were misdiagnosed with, Dr. Hayes said.

Timely diagnosis and treatment was more of an issue for the misdiagnosed patients; their diagnosis was made on average 5 days after the onset of symptoms versus 3 days (P < .001). “We found that time to treatment, particularly time to IVIg, was significantly longer in the misdiagnosed group,” Dr. Hayes said, at 5 versus 2 days (P < .001).

Dr. Hayes has no relevant financial relationships to disclose.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”

Dr. Fauci predicts a vaccine answer in mid-November

In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.

Glaring racial health disparities in U.S.

Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”

COVID-19 diagnostics

Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.

Long-term effects of COVID-19

Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.

Challenging cases in COVID-19: Through fire and water

In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).

Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
 

In-hospital infection prevention

The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.

There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
 

Preventing COVID transmission in the community

Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”

Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
 

COVID-19 vaccines

As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”

The good, the bad, and the ugly during COVID-19 in Latin America

Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.

The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.

In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
 

Diagnostics and therapeutics in Latin America

Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.

Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
 

The COVID-19 experience in Japan

Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.

The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
 

Swift response in Asia Pacific region

Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.

Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.

The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”

In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.

Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
 

China past the first wave

China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.

Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.

“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”

Time to Call for an ‘Arab CDC?’

The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.

Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.

Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
 

Africa is “not out of the woods yet”

The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.

Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.

Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
 

Diagnostic pitfalls in COVID-19

Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.

Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.

Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
 

Misinformation in the first digital pandemic

The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”

People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
 

Treatment in the ICU

Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.

Breaking the chains of transmission

During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.

Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.

“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”

Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”

This article first appeared on Medscape.com.

Only 30.6% of American adolescents complete three routinely recommended vaccinations, new research has found, but that number varies widely by state.

The Advisory Committee on Immunization Practices recommends that, by age 17 years, adolescents complete three key immunizations: human papillomavirus (HPV), quadrivalent meningococcal conjugate (MenACWY), and Tdap.

Sara Poston, PharmD, senior director for health outcomes research at GlaxoSmithKline, said at a press conference during IDWeek, an annual scientific meeting on infectious diseases held virtually this year, that her team set out to determine how many teens were completing the vaccinations and how the number varied by state and by behavioral factors.

Completion of the vaccines means getting the HPV series (two doses for people aged 9-14 years at first vaccination or three doses for those aged 15 years or older at first vaccination), completion of the MenACWY series (two doses), and getting a Tdap vaccine (one dose).
 

Rhode Island has the highest rates

Some states are clearly doing better than others. Idaho had the lowest completion rate (11.3%; 95% confidence interval, 6.9%-18.0%), and Rhode Island had the highest (56.4%; 95% CI, 49.8%-62.8%).

In the 2018 National Immunization Survey–Teen (NIS-Teen), Rhode Island had the highest vaccination coverage rate in the nation for meningococcal vaccine (98.7%) and the second-highest coverage rate for Tdap (96.3%) for adolescents aged 13-17 years. Also in 2018, the state had the highest vaccination rates in the nation for the HPV series for both male and female adolescents 13-17 years of age (78.1%), well above the national average of 51.1%.

Researchers used information from the Centers for Disease Control and Prevention as well as 2015-2018 NIS-Teen data to estimate national and state-level completion rates by age 17. They then combined NIS-Teen data with public state-level data to evaluate what was driving or discouraging completion.

“The good news is, we found some variables that we consider actionable and can be used by states and local health departments to improve the rates,” Dr. Poston said.

Those include encouraging a health care visit at age 16 or 17, provider recommendations to families to get the HPV vaccine, and state-level mandates for the MenACWY vaccine.

Those who had a health care visit at 16 or 17 were more than twice as likely to complete their vaccines (odds ratio, 2.35; 95% CI, 1.80-3.07). Those for whom HPV vaccination had ever been recommended by a health care provider were more than three times as likely to complete their vaccinations (OR, 3.24; 95% CI, 2.76-3.80).

Other factors predictive of completing the vaccines included being Black or Hispanic and having Medicaid insurance.

At the state level, “living in a state with a mandate for the meningococcal ACWY vaccine in elementary or secondary school was also associated with likelihood of vaccination,” Dr. Poston said. Teens in states with mandates were 60% more likely to complete the vaccines than those in states without mandates. (OR, 1.6; 95% CI, 1.2-2.3)

Marielle Fricchione, MD, assistant professor of pediatric infectious diseases at Rush Medical College, Chicago said in an interview, “Teen vaccines are notoriously hard to get into kids because it’s hard to get them back into the office for second doses.”

She said that Illinois is one of the states with a two-dose mandate for MenACWY before entering 6th grade and 12th grade, which has kept vaccination coverage high.

Educating providers on how to recommend HPV vaccination is the biggest vaccine focus, she added.
 

Schedule next dose at first visit

One thing her department has found successful in HPV completion is scheduling the second dose while the teen is in the office for the first dose.

“Also, you have to recommend it just as strongly for boys as you do for girls, because oropharyngeal cancer is like an epidemic right now for men, and HPV-related oropharyngeal cancer is on an exponential rise,” Dr. Fricchione said.

According to the CDC, HPV is thought to cause 70% of oropharyngeal cancers in the United States.

Equipping providers with statistics on the effectiveness of HPV vaccination in preventing cancer can take away the uneasiness in talking about sexual transmission.

“That really seems to help them give a strong recommendation. It puts them in a data-driven position to talk about the vaccine,” she said. “Once you put that data in front of the providers, they’re floored.”

Research was funded by GlaxoSmithKline. Dr. Poston is employed by GlaxoSmithKline. Dr. Fricchione disclosed no relevant financial relationships.

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

Only 30.6% of American adolescents complete three routinely recommended vaccinations, new research has found, but that number varies widely by state.

The Advisory Committee on Immunization Practices recommends that, by age 17 years, adolescents complete three key immunizations: human papillomavirus (HPV), quadrivalent meningococcal conjugate (MenACWY), and Tdap.

Sara Poston, PharmD, senior director for health outcomes research at GlaxoSmithKline, said at a press conference during IDWeek, an annual scientific meeting on infectious diseases held virtually this year, that her team set out to determine how many teens were completing the vaccinations and how the number varied by state and by behavioral factors.

Completion of the vaccines means getting the HPV series (two doses for people aged 9-14 years at first vaccination or three doses for those aged 15 years or older at first vaccination), completion of the MenACWY series (two doses), and getting a Tdap vaccine (one dose).
 

Rhode Island has the highest rates

Some states are clearly doing better than others. Idaho had the lowest completion rate (11.3%; 95% confidence interval, 6.9%-18.0%), and Rhode Island had the highest (56.4%; 95% CI, 49.8%-62.8%).

In the 2018 National Immunization Survey–Teen (NIS-Teen), Rhode Island had the highest vaccination coverage rate in the nation for meningococcal vaccine (98.7%) and the second-highest coverage rate for Tdap (96.3%) for adolescents aged 13-17 years. Also in 2018, the state had the highest vaccination rates in the nation for the HPV series for both male and female adolescents 13-17 years of age (78.1%), well above the national average of 51.1%.

Researchers used information from the Centers for Disease Control and Prevention as well as 2015-2018 NIS-Teen data to estimate national and state-level completion rates by age 17. They then combined NIS-Teen data with public state-level data to evaluate what was driving or discouraging completion.

“The good news is, we found some variables that we consider actionable and can be used by states and local health departments to improve the rates,” Dr. Poston said.

Those include encouraging a health care visit at age 16 or 17, provider recommendations to families to get the HPV vaccine, and state-level mandates for the MenACWY vaccine.

Those who had a health care visit at 16 or 17 were more than twice as likely to complete their vaccines (odds ratio, 2.35; 95% CI, 1.80-3.07). Those for whom HPV vaccination had ever been recommended by a health care provider were more than three times as likely to complete their vaccinations (OR, 3.24; 95% CI, 2.76-3.80).

Other factors predictive of completing the vaccines included being Black or Hispanic and having Medicaid insurance.

At the state level, “living in a state with a mandate for the meningococcal ACWY vaccine in elementary or secondary school was also associated with likelihood of vaccination,” Dr. Poston said. Teens in states with mandates were 60% more likely to complete the vaccines than those in states without mandates. (OR, 1.6; 95% CI, 1.2-2.3)

Marielle Fricchione, MD, assistant professor of pediatric infectious diseases at Rush Medical College, Chicago said in an interview, “Teen vaccines are notoriously hard to get into kids because it’s hard to get them back into the office for second doses.”

She said that Illinois is one of the states with a two-dose mandate for MenACWY before entering 6th grade and 12th grade, which has kept vaccination coverage high.

Educating providers on how to recommend HPV vaccination is the biggest vaccine focus, she added.
 

Schedule next dose at first visit

One thing her department has found successful in HPV completion is scheduling the second dose while the teen is in the office for the first dose.

“Also, you have to recommend it just as strongly for boys as you do for girls, because oropharyngeal cancer is like an epidemic right now for men, and HPV-related oropharyngeal cancer is on an exponential rise,” Dr. Fricchione said.

According to the CDC, HPV is thought to cause 70% of oropharyngeal cancers in the United States.

Equipping providers with statistics on the effectiveness of HPV vaccination in preventing cancer can take away the uneasiness in talking about sexual transmission.

“That really seems to help them give a strong recommendation. It puts them in a data-driven position to talk about the vaccine,” she said. “Once you put that data in front of the providers, they’re floored.”

Research was funded by GlaxoSmithKline. Dr. Poston is employed by GlaxoSmithKline. Dr. Fricchione disclosed no relevant financial relationships.

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

Only 30.6% of American adolescents complete three routinely recommended vaccinations, new research has found, but that number varies widely by state.

The Advisory Committee on Immunization Practices recommends that, by age 17 years, adolescents complete three key immunizations: human papillomavirus (HPV), quadrivalent meningococcal conjugate (MenACWY), and Tdap.

Sara Poston, PharmD, senior director for health outcomes research at GlaxoSmithKline, said at a press conference during IDWeek, an annual scientific meeting on infectious diseases held virtually this year, that her team set out to determine how many teens were completing the vaccinations and how the number varied by state and by behavioral factors.

Completion of the vaccines means getting the HPV series (two doses for people aged 9-14 years at first vaccination or three doses for those aged 15 years or older at first vaccination), completion of the MenACWY series (two doses), and getting a Tdap vaccine (one dose).
 

Rhode Island has the highest rates

Some states are clearly doing better than others. Idaho had the lowest completion rate (11.3%; 95% confidence interval, 6.9%-18.0%), and Rhode Island had the highest (56.4%; 95% CI, 49.8%-62.8%).

In the 2018 National Immunization Survey–Teen (NIS-Teen), Rhode Island had the highest vaccination coverage rate in the nation for meningococcal vaccine (98.7%) and the second-highest coverage rate for Tdap (96.3%) for adolescents aged 13-17 years. Also in 2018, the state had the highest vaccination rates in the nation for the HPV series for both male and female adolescents 13-17 years of age (78.1%), well above the national average of 51.1%.

Researchers used information from the Centers for Disease Control and Prevention as well as 2015-2018 NIS-Teen data to estimate national and state-level completion rates by age 17. They then combined NIS-Teen data with public state-level data to evaluate what was driving or discouraging completion.

“The good news is, we found some variables that we consider actionable and can be used by states and local health departments to improve the rates,” Dr. Poston said.

Those include encouraging a health care visit at age 16 or 17, provider recommendations to families to get the HPV vaccine, and state-level mandates for the MenACWY vaccine.

Those who had a health care visit at 16 or 17 were more than twice as likely to complete their vaccines (odds ratio, 2.35; 95% CI, 1.80-3.07). Those for whom HPV vaccination had ever been recommended by a health care provider were more than three times as likely to complete their vaccinations (OR, 3.24; 95% CI, 2.76-3.80).

Other factors predictive of completing the vaccines included being Black or Hispanic and having Medicaid insurance.

At the state level, “living in a state with a mandate for the meningococcal ACWY vaccine in elementary or secondary school was also associated with likelihood of vaccination,” Dr. Poston said. Teens in states with mandates were 60% more likely to complete the vaccines than those in states without mandates. (OR, 1.6; 95% CI, 1.2-2.3)

Marielle Fricchione, MD, assistant professor of pediatric infectious diseases at Rush Medical College, Chicago said in an interview, “Teen vaccines are notoriously hard to get into kids because it’s hard to get them back into the office for second doses.”

She said that Illinois is one of the states with a two-dose mandate for MenACWY before entering 6th grade and 12th grade, which has kept vaccination coverage high.

Educating providers on how to recommend HPV vaccination is the biggest vaccine focus, she added.
 

Schedule next dose at first visit

One thing her department has found successful in HPV completion is scheduling the second dose while the teen is in the office for the first dose.

“Also, you have to recommend it just as strongly for boys as you do for girls, because oropharyngeal cancer is like an epidemic right now for men, and HPV-related oropharyngeal cancer is on an exponential rise,” Dr. Fricchione said.

According to the CDC, HPV is thought to cause 70% of oropharyngeal cancers in the United States.

Equipping providers with statistics on the effectiveness of HPV vaccination in preventing cancer can take away the uneasiness in talking about sexual transmission.

“That really seems to help them give a strong recommendation. It puts them in a data-driven position to talk about the vaccine,” she said. “Once you put that data in front of the providers, they’re floored.”

Research was funded by GlaxoSmithKline. Dr. Poston is employed by GlaxoSmithKline. Dr. Fricchione disclosed no relevant financial relationships.

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

Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.

An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).

“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.

“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
 

Adverse event profiles

Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.

World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.

He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.

They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.

“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.

The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.

In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.

TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.

Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.

“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.

In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.

In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).

“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.

In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.

People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.

Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
 

Modern times

The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.

He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.

“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.

“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’

No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.

Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.

An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).

“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.

“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
 

Adverse event profiles

Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.

World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.

He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.

They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.

“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.

The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.

In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.

TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.

Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.

“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.

In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.

In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).

“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.

In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.

People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.

Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
 

Modern times

The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.

He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.

“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.

“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’

No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.

Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.

An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).

“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.

“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
 

Adverse event profiles

Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.

World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.

He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.

They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.

“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.

The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.

In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.

TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.

Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.

“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.

In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.

In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).

“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.

In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.

People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.

Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
 

Modern times

The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.

He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.

“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.

“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’

No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.

A patient-centered approach can help guide persons at risk for HIV exposure to decide on the best choice of pre-exposure prophylaxis (PrEP) regimens for them, stifling the noise generated by direct-to-consumer advertising, an infectious disease specialist recommends.

The decision for patients whether to start or remain on the PrEP combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC; Truvada and generic) or on tenofovir alafenamide (TAF) plus FTC (Descovy) is made more fraught by confusion regarding the use of the newer and allegedly safer TAF prodrug of tenofovir in HIV treatment regimens, said Oni Blackstock, MD, founder and executive director of Health Justice and an attending physician in the division of infectious diseases at Harlem Hospital, New York.

“There have been commercials on TV as well as on social media around class-action lawsuits against [Truvada maker] Gilead,” she said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases, held virtually this year.

“These lawsuits focus on TDF for HIV treatment, but they have sown a great deal of confusion about TDF versus TAF for PrEP among potential and actual PrEP users,” she added.

Dr. Blackstock described her approach to shared decision-making regarding TDF/FTC versus TAF/FTC, and to helping patients understand the relative benefits and risks of each formulation.

In January of 2020, Dr. Blackstock, who was then assistant commissioner of the HIV bureau of the New York City Department of Health and Mental Hygiene, issued with other Bureau members a “Dear colleague” letter stating why they believed that TDF/FTC should remain the first-line regimen for PrEP.

That opinion, she said, was bolstered by an editorial published in February 2020 by Douglas E. Krakower, MD, from Beth Israel Deaconess Medical Center in Boston, and colleagues, which questioned the rush to shift from TDF to TAF in HIV treatment, and cautioned against the same approach to PrEP.

“Despite evidence that TAF/FTC would not be cost-effective, compared with generic TDF/FTC , the newer regimen quickly and irrevocably displaced TDF/FTC for HIV treatment in the U.S. A similar shift for PrEP – especially for populations in which TAF/FTC is untested – would be premature, costly, and counterproductive for population impact,” Krakower et al. wrote.
 

Shared decision-making

Clinicians can help patients who may be a candidate for either PrEP regimen by engaging them in shared decision-making.

“The clinician provides information in this case about a prevention strategy, options, benefits and risks, alternatives, and the patient provides their preferences and values, and together the clinician and patient make a decision,” Dr. Blackstock said.

The process differs from the model of informed decision-making, where the clinician gives the patient the information and the patient comes to a decision, or the old, “paternalistic” model in which the clinician gives information and makes recommendations to the patient.

“Shared decision-making has been studied extensively and has been shown to improve patient satisfaction, patient communication, and also potentially reducing health inequities that we see,” she said.

The model for shared decision-making for clinical practice includes three distinct portions: a choice talk, option talk, and decision talk.
 

Choice

To begin the discussion, the physician informs the patients of the availability of choices and justifies them, saying, for example, “there is good information about how these two PrEP options differ that I’d like to discuss with you,” and “the two PrEP options have different side effects … some will matter more to you than other people.”

At this stage the clinician should defer closure by offering a more detailed discussion of the choices.
 

Option

Here the clinician solicits information about what the patient has heard or read about PrEP, describes each option in practical terms, and points out where the two regimens differ, being specific about the pros and cons of each (for example, potential bone mineral density loss or renal complications with TDF, and potential weight gain with subsequent metabolic and cardiovascular consequences with TAF).

The TDF versus TAF-based PrEP discussion could also focus on what’s known about the comparative effectiveness of each regimen.

For example, TDF/FTC has been shown to be about 99% effective at preventing infection in men who have sex with men and in transgender women, also about 99% effective in heterosexual women and men, and 74%-84% effective in persons who inject drugs.

In contrast, TAF/FTC has been shown to be about 99% effective in men who have sex with men and transgender women, but it’s efficacy in the other two categories is unknown, Dr. Blackstock said.

The option discussion should include a comparison of the evidence base for each regimen, including the real-world experience with TDF/FTC since 2012, and much more limited experience with TAF/FTC.

Discussing relative costs, although the wholesale costs of the regimens are similar, there is now a generic version of TDF/FTC made by Teva Pharmaceuticals that sells for about $400 less per month than the brand name, which might make the option more acceptable to health insurers.
 

Decision

The decision talk is about considering the patients preferences and deciding with them what is best.

The clinician could say, for example: “What, from your point of view, matters most to you?”

The clinician should also be willing to allow the patient to defer a decision or to guide them depending on their stated wish, asking something like: “Are you ready to decide, or do you want more time? Do you have more questions? Are there more things we should discuss?

Offering the patient a chance to review the decision can also be a good way to arrive at closure, Dr. Blackstock said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Blackstock presented her talk, said that he also uses a similar approach to the PrEP discussion.

“I use a very patient-centered approach of providing information and talking through the data that are available,” he said.

“I will say that, as patients come to me talking about the transition from TDF to TAF for pre-exposure prophylaxis, I am very clear with them about the limited benefit or no benefit that I see with TAF for pre-exposure prophylaxis, and all of my patients have remained on TDF for pre-exposure prophylaxis,” he added.

No funding source for the presentation was reported. Dr. Blackstock and Dr. Goldstein reported having no conflicts of interest to disclose.

A patient-centered approach can help guide persons at risk for HIV exposure to decide on the best choice of pre-exposure prophylaxis (PrEP) regimens for them, stifling the noise generated by direct-to-consumer advertising, an infectious disease specialist recommends.

The decision for patients whether to start or remain on the PrEP combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC; Truvada and generic) or on tenofovir alafenamide (TAF) plus FTC (Descovy) is made more fraught by confusion regarding the use of the newer and allegedly safer TAF prodrug of tenofovir in HIV treatment regimens, said Oni Blackstock, MD, founder and executive director of Health Justice and an attending physician in the division of infectious diseases at Harlem Hospital, New York.

“There have been commercials on TV as well as on social media around class-action lawsuits against [Truvada maker] Gilead,” she said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases, held virtually this year.

“These lawsuits focus on TDF for HIV treatment, but they have sown a great deal of confusion about TDF versus TAF for PrEP among potential and actual PrEP users,” she added.

Dr. Blackstock described her approach to shared decision-making regarding TDF/FTC versus TAF/FTC, and to helping patients understand the relative benefits and risks of each formulation.

In January of 2020, Dr. Blackstock, who was then assistant commissioner of the HIV bureau of the New York City Department of Health and Mental Hygiene, issued with other Bureau members a “Dear colleague” letter stating why they believed that TDF/FTC should remain the first-line regimen for PrEP.

That opinion, she said, was bolstered by an editorial published in February 2020 by Douglas E. Krakower, MD, from Beth Israel Deaconess Medical Center in Boston, and colleagues, which questioned the rush to shift from TDF to TAF in HIV treatment, and cautioned against the same approach to PrEP.

“Despite evidence that TAF/FTC would not be cost-effective, compared with generic TDF/FTC , the newer regimen quickly and irrevocably displaced TDF/FTC for HIV treatment in the U.S. A similar shift for PrEP – especially for populations in which TAF/FTC is untested – would be premature, costly, and counterproductive for population impact,” Krakower et al. wrote.
 

Shared decision-making

Clinicians can help patients who may be a candidate for either PrEP regimen by engaging them in shared decision-making.

“The clinician provides information in this case about a prevention strategy, options, benefits and risks, alternatives, and the patient provides their preferences and values, and together the clinician and patient make a decision,” Dr. Blackstock said.

The process differs from the model of informed decision-making, where the clinician gives the patient the information and the patient comes to a decision, or the old, “paternalistic” model in which the clinician gives information and makes recommendations to the patient.

“Shared decision-making has been studied extensively and has been shown to improve patient satisfaction, patient communication, and also potentially reducing health inequities that we see,” she said.

The model for shared decision-making for clinical practice includes three distinct portions: a choice talk, option talk, and decision talk.
 

Choice

To begin the discussion, the physician informs the patients of the availability of choices and justifies them, saying, for example, “there is good information about how these two PrEP options differ that I’d like to discuss with you,” and “the two PrEP options have different side effects … some will matter more to you than other people.”

At this stage the clinician should defer closure by offering a more detailed discussion of the choices.
 

Option

Here the clinician solicits information about what the patient has heard or read about PrEP, describes each option in practical terms, and points out where the two regimens differ, being specific about the pros and cons of each (for example, potential bone mineral density loss or renal complications with TDF, and potential weight gain with subsequent metabolic and cardiovascular consequences with TAF).

The TDF versus TAF-based PrEP discussion could also focus on what’s known about the comparative effectiveness of each regimen.

For example, TDF/FTC has been shown to be about 99% effective at preventing infection in men who have sex with men and in transgender women, also about 99% effective in heterosexual women and men, and 74%-84% effective in persons who inject drugs.

In contrast, TAF/FTC has been shown to be about 99% effective in men who have sex with men and transgender women, but it’s efficacy in the other two categories is unknown, Dr. Blackstock said.

The option discussion should include a comparison of the evidence base for each regimen, including the real-world experience with TDF/FTC since 2012, and much more limited experience with TAF/FTC.

Discussing relative costs, although the wholesale costs of the regimens are similar, there is now a generic version of TDF/FTC made by Teva Pharmaceuticals that sells for about $400 less per month than the brand name, which might make the option more acceptable to health insurers.
 

Decision

The decision talk is about considering the patients preferences and deciding with them what is best.

The clinician could say, for example: “What, from your point of view, matters most to you?”

The clinician should also be willing to allow the patient to defer a decision or to guide them depending on their stated wish, asking something like: “Are you ready to decide, or do you want more time? Do you have more questions? Are there more things we should discuss?

Offering the patient a chance to review the decision can also be a good way to arrive at closure, Dr. Blackstock said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Blackstock presented her talk, said that he also uses a similar approach to the PrEP discussion.

“I use a very patient-centered approach of providing information and talking through the data that are available,” he said.

“I will say that, as patients come to me talking about the transition from TDF to TAF for pre-exposure prophylaxis, I am very clear with them about the limited benefit or no benefit that I see with TAF for pre-exposure prophylaxis, and all of my patients have remained on TDF for pre-exposure prophylaxis,” he added.

No funding source for the presentation was reported. Dr. Blackstock and Dr. Goldstein reported having no conflicts of interest to disclose.

A patient-centered approach can help guide persons at risk for HIV exposure to decide on the best choice of pre-exposure prophylaxis (PrEP) regimens for them, stifling the noise generated by direct-to-consumer advertising, an infectious disease specialist recommends.

The decision for patients whether to start or remain on the PrEP combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC; Truvada and generic) or on tenofovir alafenamide (TAF) plus FTC (Descovy) is made more fraught by confusion regarding the use of the newer and allegedly safer TAF prodrug of tenofovir in HIV treatment regimens, said Oni Blackstock, MD, founder and executive director of Health Justice and an attending physician in the division of infectious diseases at Harlem Hospital, New York.

“There have been commercials on TV as well as on social media around class-action lawsuits against [Truvada maker] Gilead,” she said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases, held virtually this year.

“These lawsuits focus on TDF for HIV treatment, but they have sown a great deal of confusion about TDF versus TAF for PrEP among potential and actual PrEP users,” she added.

Dr. Blackstock described her approach to shared decision-making regarding TDF/FTC versus TAF/FTC, and to helping patients understand the relative benefits and risks of each formulation.

In January of 2020, Dr. Blackstock, who was then assistant commissioner of the HIV bureau of the New York City Department of Health and Mental Hygiene, issued with other Bureau members a “Dear colleague” letter stating why they believed that TDF/FTC should remain the first-line regimen for PrEP.

That opinion, she said, was bolstered by an editorial published in February 2020 by Douglas E. Krakower, MD, from Beth Israel Deaconess Medical Center in Boston, and colleagues, which questioned the rush to shift from TDF to TAF in HIV treatment, and cautioned against the same approach to PrEP.

“Despite evidence that TAF/FTC would not be cost-effective, compared with generic TDF/FTC , the newer regimen quickly and irrevocably displaced TDF/FTC for HIV treatment in the U.S. A similar shift for PrEP – especially for populations in which TAF/FTC is untested – would be premature, costly, and counterproductive for population impact,” Krakower et al. wrote.
 

Shared decision-making

Clinicians can help patients who may be a candidate for either PrEP regimen by engaging them in shared decision-making.

“The clinician provides information in this case about a prevention strategy, options, benefits and risks, alternatives, and the patient provides their preferences and values, and together the clinician and patient make a decision,” Dr. Blackstock said.

The process differs from the model of informed decision-making, where the clinician gives the patient the information and the patient comes to a decision, or the old, “paternalistic” model in which the clinician gives information and makes recommendations to the patient.

“Shared decision-making has been studied extensively and has been shown to improve patient satisfaction, patient communication, and also potentially reducing health inequities that we see,” she said.

The model for shared decision-making for clinical practice includes three distinct portions: a choice talk, option talk, and decision talk.
 

Choice

To begin the discussion, the physician informs the patients of the availability of choices and justifies them, saying, for example, “there is good information about how these two PrEP options differ that I’d like to discuss with you,” and “the two PrEP options have different side effects … some will matter more to you than other people.”

At this stage the clinician should defer closure by offering a more detailed discussion of the choices.
 

Option

Here the clinician solicits information about what the patient has heard or read about PrEP, describes each option in practical terms, and points out where the two regimens differ, being specific about the pros and cons of each (for example, potential bone mineral density loss or renal complications with TDF, and potential weight gain with subsequent metabolic and cardiovascular consequences with TAF).

The TDF versus TAF-based PrEP discussion could also focus on what’s known about the comparative effectiveness of each regimen.

For example, TDF/FTC has been shown to be about 99% effective at preventing infection in men who have sex with men and in transgender women, also about 99% effective in heterosexual women and men, and 74%-84% effective in persons who inject drugs.

In contrast, TAF/FTC has been shown to be about 99% effective in men who have sex with men and transgender women, but it’s efficacy in the other two categories is unknown, Dr. Blackstock said.

The option discussion should include a comparison of the evidence base for each regimen, including the real-world experience with TDF/FTC since 2012, and much more limited experience with TAF/FTC.

Discussing relative costs, although the wholesale costs of the regimens are similar, there is now a generic version of TDF/FTC made by Teva Pharmaceuticals that sells for about $400 less per month than the brand name, which might make the option more acceptable to health insurers.
 

Decision

The decision talk is about considering the patients preferences and deciding with them what is best.

The clinician could say, for example: “What, from your point of view, matters most to you?”

The clinician should also be willing to allow the patient to defer a decision or to guide them depending on their stated wish, asking something like: “Are you ready to decide, or do you want more time? Do you have more questions? Are there more things we should discuss?

Offering the patient a chance to review the decision can also be a good way to arrive at closure, Dr. Blackstock said.

Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Blackstock presented her talk, said that he also uses a similar approach to the PrEP discussion.

“I use a very patient-centered approach of providing information and talking through the data that are available,” he said.

“I will say that, as patients come to me talking about the transition from TDF to TAF for pre-exposure prophylaxis, I am very clear with them about the limited benefit or no benefit that I see with TAF for pre-exposure prophylaxis, and all of my patients have remained on TDF for pre-exposure prophylaxis,” he added.

No funding source for the presentation was reported. Dr. Blackstock and Dr. Goldstein reported having no conflicts of interest to disclose.

Among children with persistent postconcussion symptoms, poor recovery at 10 weeks is associated with higher cerebral blood flow at 4-6 weeks, according to a study presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Furthermore, cerebral blood flow at 4-6 weeks predicts recovery during the next 4 weeks in 77% of children.

“This is the first study to examine cerebral blood flow changes in children with persistent postconcussion symptoms,” said Karen Barlow, MBChB, associate professor of biomedical sciences at the University of Queensland in St. Lucia, Australia. “Our findings support the link between neurovascular unit dysfunction and persistent postconcussion symptoms in children, potentially because of injury or dysfunction in the GABAergic interneurons.”
 

Quantifying cerebral tissue perfusion

At least 25% of children with concussion have persistent postconcussion symptoms at 1 month post injury. Understanding the factors that influence the speed of recovery may help clarify the biology of postconcussion symptoms and suggest new treatments. In previous research, Dr. Barlow and colleagues found that children with early recovery (i.e., recovery by 4 weeks post injury) have decreases in cerebral blood flow, when compared with normal children. Children with persistent symptoms, however, have increases in cerebral blood flow. Dr. Barlow and colleagues conducted a new study to examine how cerebral blood flow changes in children with persistent postconcussion symptoms.

The investigators recruited participants through the randomized controlled Play Game trial, which examined melatonin as a treatment for persistent postconcussion symptoms. Among the exclusion criteria were history of assault, drug or alcohol use, significant past medical or psychiatric history, concussion within the previous 3 months, and use of psychoactive medications.

Children entered the study at 4-8 weeks after injury and received treatment for 4 weeks. Participants underwent 3-D pseudo-continuous arterial spin–labeled MRI before and after the treatment period (i.e., at 5 and 10 weeks post injury). This imaging technique provides a quantitative assessment of cerebral tissue perfusion. “You can do it without manipulating the cerebral circulation, making it particularly useful for research and in children,” said Dr. Barlow.

She and her colleagues evaluated recovery using the Post-Concussion Symptom Inventory. They defined good recovery as a total score at or below baseline at 10 weeks post injury. They considered any children who did not meet this criterion to have poor recovery.
 

Speed of blood-flow change varied

In all, 124 children were eligible for the study, and 76 had MRIs at both time points. Fourteen participants were excluded because of motion artifacts, slice truncation, and normalization failure. The population’s average age was approximately 14 years. About half of participants were males. The first MRI was performed at 37 days post injury, and the second MRI at around 70 days post injury. Twenty-three children had good recovery.

Children with poor recovery at 10 weeks had higher relative cerebral blood flow, compared with children with good recovery. Treatment group, age, and sex did not affect the changes in relative cerebral blood flow over time. Dr. Barlow and colleagues also measured mean total gray matter cerebral blood flow. Children with poor recovery had higher cerebral blood flow at 5 and 10 weeks post injury, compared with children with good recovery. In addition, cerebral blood flow changed more slowly in participants with poor recovery, compared with those with good recovery. Logistic regression analysis indicated that the mean absolute gray matter cerebral blood flow at 4-6 weeks post injury significantly predicted which children would recover by 10 weeks post injury, with an area under the receiver operating characteristic curve of 77%.

Funders for the study included Alberta Children’s Hospital, the Canadian Institutes of Health Research, and the University of Calgary. Dr. Barlow had no disclosures or conflicts of interest.

egreb@mdedge.com

SOURCE: Barlow K et al. CNS-ICNA 2020. Abstract PL100.

Among children with persistent postconcussion symptoms, poor recovery at 10 weeks is associated with higher cerebral blood flow at 4-6 weeks, according to a study presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Furthermore, cerebral blood flow at 4-6 weeks predicts recovery during the next 4 weeks in 77% of children.

“This is the first study to examine cerebral blood flow changes in children with persistent postconcussion symptoms,” said Karen Barlow, MBChB, associate professor of biomedical sciences at the University of Queensland in St. Lucia, Australia. “Our findings support the link between neurovascular unit dysfunction and persistent postconcussion symptoms in children, potentially because of injury or dysfunction in the GABAergic interneurons.”
 

Quantifying cerebral tissue perfusion

At least 25% of children with concussion have persistent postconcussion symptoms at 1 month post injury. Understanding the factors that influence the speed of recovery may help clarify the biology of postconcussion symptoms and suggest new treatments. In previous research, Dr. Barlow and colleagues found that children with early recovery (i.e., recovery by 4 weeks post injury) have decreases in cerebral blood flow, when compared with normal children. Children with persistent symptoms, however, have increases in cerebral blood flow. Dr. Barlow and colleagues conducted a new study to examine how cerebral blood flow changes in children with persistent postconcussion symptoms.

The investigators recruited participants through the randomized controlled Play Game trial, which examined melatonin as a treatment for persistent postconcussion symptoms. Among the exclusion criteria were history of assault, drug or alcohol use, significant past medical or psychiatric history, concussion within the previous 3 months, and use of psychoactive medications.

Children entered the study at 4-8 weeks after injury and received treatment for 4 weeks. Participants underwent 3-D pseudo-continuous arterial spin–labeled MRI before and after the treatment period (i.e., at 5 and 10 weeks post injury). This imaging technique provides a quantitative assessment of cerebral tissue perfusion. “You can do it without manipulating the cerebral circulation, making it particularly useful for research and in children,” said Dr. Barlow.

She and her colleagues evaluated recovery using the Post-Concussion Symptom Inventory. They defined good recovery as a total score at or below baseline at 10 weeks post injury. They considered any children who did not meet this criterion to have poor recovery.
 

Speed of blood-flow change varied

In all, 124 children were eligible for the study, and 76 had MRIs at both time points. Fourteen participants were excluded because of motion artifacts, slice truncation, and normalization failure. The population’s average age was approximately 14 years. About half of participants were males. The first MRI was performed at 37 days post injury, and the second MRI at around 70 days post injury. Twenty-three children had good recovery.

Children with poor recovery at 10 weeks had higher relative cerebral blood flow, compared with children with good recovery. Treatment group, age, and sex did not affect the changes in relative cerebral blood flow over time. Dr. Barlow and colleagues also measured mean total gray matter cerebral blood flow. Children with poor recovery had higher cerebral blood flow at 5 and 10 weeks post injury, compared with children with good recovery. In addition, cerebral blood flow changed more slowly in participants with poor recovery, compared with those with good recovery. Logistic regression analysis indicated that the mean absolute gray matter cerebral blood flow at 4-6 weeks post injury significantly predicted which children would recover by 10 weeks post injury, with an area under the receiver operating characteristic curve of 77%.

Funders for the study included Alberta Children’s Hospital, the Canadian Institutes of Health Research, and the University of Calgary. Dr. Barlow had no disclosures or conflicts of interest.

egreb@mdedge.com

SOURCE: Barlow K et al. CNS-ICNA 2020. Abstract PL100.

Among children with persistent postconcussion symptoms, poor recovery at 10 weeks is associated with higher cerebral blood flow at 4-6 weeks, according to a study presented at the 2020 CNS-ICNA Conjoint Meeting, held virtually this year. Furthermore, cerebral blood flow at 4-6 weeks predicts recovery during the next 4 weeks in 77% of children.

“This is the first study to examine cerebral blood flow changes in children with persistent postconcussion symptoms,” said Karen Barlow, MBChB, associate professor of biomedical sciences at the University of Queensland in St. Lucia, Australia. “Our findings support the link between neurovascular unit dysfunction and persistent postconcussion symptoms in children, potentially because of injury or dysfunction in the GABAergic interneurons.”
 

Quantifying cerebral tissue perfusion

At least 25% of children with concussion have persistent postconcussion symptoms at 1 month post injury. Understanding the factors that influence the speed of recovery may help clarify the biology of postconcussion symptoms and suggest new treatments. In previous research, Dr. Barlow and colleagues found that children with early recovery (i.e., recovery by 4 weeks post injury) have decreases in cerebral blood flow, when compared with normal children. Children with persistent symptoms, however, have increases in cerebral blood flow. Dr. Barlow and colleagues conducted a new study to examine how cerebral blood flow changes in children with persistent postconcussion symptoms.

The investigators recruited participants through the randomized controlled Play Game trial, which examined melatonin as a treatment for persistent postconcussion symptoms. Among the exclusion criteria were history of assault, drug or alcohol use, significant past medical or psychiatric history, concussion within the previous 3 months, and use of psychoactive medications.

Children entered the study at 4-8 weeks after injury and received treatment for 4 weeks. Participants underwent 3-D pseudo-continuous arterial spin–labeled MRI before and after the treatment period (i.e., at 5 and 10 weeks post injury). This imaging technique provides a quantitative assessment of cerebral tissue perfusion. “You can do it without manipulating the cerebral circulation, making it particularly useful for research and in children,” said Dr. Barlow.

She and her colleagues evaluated recovery using the Post-Concussion Symptom Inventory. They defined good recovery as a total score at or below baseline at 10 weeks post injury. They considered any children who did not meet this criterion to have poor recovery.
 

Speed of blood-flow change varied

In all, 124 children were eligible for the study, and 76 had MRIs at both time points. Fourteen participants were excluded because of motion artifacts, slice truncation, and normalization failure. The population’s average age was approximately 14 years. About half of participants were males. The first MRI was performed at 37 days post injury, and the second MRI at around 70 days post injury. Twenty-three children had good recovery.

Children with poor recovery at 10 weeks had higher relative cerebral blood flow, compared with children with good recovery. Treatment group, age, and sex did not affect the changes in relative cerebral blood flow over time. Dr. Barlow and colleagues also measured mean total gray matter cerebral blood flow. Children with poor recovery had higher cerebral blood flow at 5 and 10 weeks post injury, compared with children with good recovery. In addition, cerebral blood flow changed more slowly in participants with poor recovery, compared with those with good recovery. Logistic regression analysis indicated that the mean absolute gray matter cerebral blood flow at 4-6 weeks post injury significantly predicted which children would recover by 10 weeks post injury, with an area under the receiver operating characteristic curve of 77%.

Funders for the study included Alberta Children’s Hospital, the Canadian Institutes of Health Research, and the University of Calgary. Dr. Barlow had no disclosures or conflicts of interest.

egreb@mdedge.com

SOURCE: Barlow K et al. CNS-ICNA 2020. Abstract PL100.

A significant number of patients leave the hospital with inappropriate drugs because of a lack of medication reconciliation at discharge, new research shows.

Proton pump inhibitors – known to have adverse effects, such as fractures, osteoporosis, and progressive kidney disease – make up 30% of inappropriate prescriptions at discharge.

“These medications can have a significant toxic effect, especially in the long term,” said Harsh Patel, MD, from Medical City Healthcare in Fort Worth, Tex.

And “when we interviewed patients, they were unable to recall ever partaking in a pulmonary function test or endoscopy to warrant the medications,” he said in an interview.

For their retrospective chart review, Dr. Patel and colleagues assessed patients admitted to the ICU in 13 hospitals over a 6-month period in northern Texas. Of the 12,930 patients, 2,557 had not previously received but were prescribed during their hospital stay a bronchodilator, a proton pump inhibitor, or an H₂ receptor agonist.

Of those 2,557 patients, 26.8% were discharged on a proton pump inhibitor, 8.4% on an H₂ receptor agonist, and 5.49% on a bronchodilator.

There were no corresponding diseases or diagnoses to justify continued use, Dr. Patel said during his presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

Button fatigue

The problem stems from a technology disconnect when patients are transferred from the ICU to the general population.

Doctors expect that the medications will be reconciled at discharge, said one of the study investigators, Prashanth Reddy, MD, from Medical City Las Colinas (Tex.).

But in some instances, clinicians unfamiliar with the case click through the electronic health record to get the patient “out of the ICU to the floor,” he explained. “They don’t always know what medications to keep.”

“They may have button fatigue, so they just accept and continue,” Dr. Reddy said in an interviews.

In light of these findings, the team has kick-started a project to improve transition out of the ICU and minimize overprescription at discharge.

“This is the kind of a problem where we thought we could have some influence,” said Dr. Reddy.

One solution would be to put “stop orders” on potentially harmful medications. “But we don’t want to increase button fatigue even more, so we have to find a happy medium,” he said. “It’s going to take a while to formulate the best path on this.”

The inclusion of pharmacy residents in rounds could make a difference. “When we rounded with pharmacy residents, these issues got addressed,” Dr. Patel said. The pharmacy residents often asked: “Can we go over the meds? Does this person really need all this?”

Medication reconciliations not only have a positive effect on a patient’s health, they can also cut costs by eliminating unneeded drugs. And “patients are always happy to hear we’re taking them off a drug,” Dr. Patel added.

He said he remembers one of his mentors telling him that, if he could get his patients down to five medications, “then you’ve achieved success as a physician.”

“I’m still working toward that,” he said. “The end goal should sometimes be, less is more.”
 

COPD patients overprescribed home oxygen

In addition to medications, home oxygen therapy is often prescribed when patients are discharged from the hospital.

A study of 69 patients who were continued on home oxygen therapy after hospitalization for an exacerbation of chronic obstructive pulmonary disease was presented by Analisa Taylor, MD, from the University of Illinois at Chicago.

Despite guideline recommendations that patients be reassessed within 90 days of discharge, only 38 patients in the cohort were reassessed, and “28 were considered eligible for discontinuation,” she said during her presentation.

However, “of those, only four were ultimately discontinued,” she reported.

The reason for this gap needs to be examined, noted Dr. Taylor, suggesting that “perhaps clinical inertia plays a role in the continuation of previously prescribed therapy despite a lack of ongoing clinical benefit.”

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

A significant number of patients leave the hospital with inappropriate drugs because of a lack of medication reconciliation at discharge, new research shows.

Proton pump inhibitors – known to have adverse effects, such as fractures, osteoporosis, and progressive kidney disease – make up 30% of inappropriate prescriptions at discharge.

“These medications can have a significant toxic effect, especially in the long term,” said Harsh Patel, MD, from Medical City Healthcare in Fort Worth, Tex.

And “when we interviewed patients, they were unable to recall ever partaking in a pulmonary function test or endoscopy to warrant the medications,” he said in an interview.

For their retrospective chart review, Dr. Patel and colleagues assessed patients admitted to the ICU in 13 hospitals over a 6-month period in northern Texas. Of the 12,930 patients, 2,557 had not previously received but were prescribed during their hospital stay a bronchodilator, a proton pump inhibitor, or an H₂ receptor agonist.

Of those 2,557 patients, 26.8% were discharged on a proton pump inhibitor, 8.4% on an H₂ receptor agonist, and 5.49% on a bronchodilator.

There were no corresponding diseases or diagnoses to justify continued use, Dr. Patel said during his presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

Button fatigue

The problem stems from a technology disconnect when patients are transferred from the ICU to the general population.

Doctors expect that the medications will be reconciled at discharge, said one of the study investigators, Prashanth Reddy, MD, from Medical City Las Colinas (Tex.).

But in some instances, clinicians unfamiliar with the case click through the electronic health record to get the patient “out of the ICU to the floor,” he explained. “They don’t always know what medications to keep.”

“They may have button fatigue, so they just accept and continue,” Dr. Reddy said in an interviews.

In light of these findings, the team has kick-started a project to improve transition out of the ICU and minimize overprescription at discharge.

“This is the kind of a problem where we thought we could have some influence,” said Dr. Reddy.

One solution would be to put “stop orders” on potentially harmful medications. “But we don’t want to increase button fatigue even more, so we have to find a happy medium,” he said. “It’s going to take a while to formulate the best path on this.”

The inclusion of pharmacy residents in rounds could make a difference. “When we rounded with pharmacy residents, these issues got addressed,” Dr. Patel said. The pharmacy residents often asked: “Can we go over the meds? Does this person really need all this?”

Medication reconciliations not only have a positive effect on a patient’s health, they can also cut costs by eliminating unneeded drugs. And “patients are always happy to hear we’re taking them off a drug,” Dr. Patel added.

He said he remembers one of his mentors telling him that, if he could get his patients down to five medications, “then you’ve achieved success as a physician.”

“I’m still working toward that,” he said. “The end goal should sometimes be, less is more.”
 

COPD patients overprescribed home oxygen

In addition to medications, home oxygen therapy is often prescribed when patients are discharged from the hospital.

A study of 69 patients who were continued on home oxygen therapy after hospitalization for an exacerbation of chronic obstructive pulmonary disease was presented by Analisa Taylor, MD, from the University of Illinois at Chicago.

Despite guideline recommendations that patients be reassessed within 90 days of discharge, only 38 patients in the cohort were reassessed, and “28 were considered eligible for discontinuation,” she said during her presentation.

However, “of those, only four were ultimately discontinued,” she reported.

The reason for this gap needs to be examined, noted Dr. Taylor, suggesting that “perhaps clinical inertia plays a role in the continuation of previously prescribed therapy despite a lack of ongoing clinical benefit.”

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

A significant number of patients leave the hospital with inappropriate drugs because of a lack of medication reconciliation at discharge, new research shows.

Proton pump inhibitors – known to have adverse effects, such as fractures, osteoporosis, and progressive kidney disease – make up 30% of inappropriate prescriptions at discharge.

“These medications can have a significant toxic effect, especially in the long term,” said Harsh Patel, MD, from Medical City Healthcare in Fort Worth, Tex.

And “when we interviewed patients, they were unable to recall ever partaking in a pulmonary function test or endoscopy to warrant the medications,” he said in an interview.

For their retrospective chart review, Dr. Patel and colleagues assessed patients admitted to the ICU in 13 hospitals over a 6-month period in northern Texas. Of the 12,930 patients, 2,557 had not previously received but were prescribed during their hospital stay a bronchodilator, a proton pump inhibitor, or an H₂ receptor agonist.

Of those 2,557 patients, 26.8% were discharged on a proton pump inhibitor, 8.4% on an H₂ receptor agonist, and 5.49% on a bronchodilator.

There were no corresponding diseases or diagnoses to justify continued use, Dr. Patel said during his presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

Button fatigue

The problem stems from a technology disconnect when patients are transferred from the ICU to the general population.

Doctors expect that the medications will be reconciled at discharge, said one of the study investigators, Prashanth Reddy, MD, from Medical City Las Colinas (Tex.).

But in some instances, clinicians unfamiliar with the case click through the electronic health record to get the patient “out of the ICU to the floor,” he explained. “They don’t always know what medications to keep.”

“They may have button fatigue, so they just accept and continue,” Dr. Reddy said in an interviews.

In light of these findings, the team has kick-started a project to improve transition out of the ICU and minimize overprescription at discharge.

“This is the kind of a problem where we thought we could have some influence,” said Dr. Reddy.

One solution would be to put “stop orders” on potentially harmful medications. “But we don’t want to increase button fatigue even more, so we have to find a happy medium,” he said. “It’s going to take a while to formulate the best path on this.”

The inclusion of pharmacy residents in rounds could make a difference. “When we rounded with pharmacy residents, these issues got addressed,” Dr. Patel said. The pharmacy residents often asked: “Can we go over the meds? Does this person really need all this?”

Medication reconciliations not only have a positive effect on a patient’s health, they can also cut costs by eliminating unneeded drugs. And “patients are always happy to hear we’re taking them off a drug,” Dr. Patel added.

He said he remembers one of his mentors telling him that, if he could get his patients down to five medications, “then you’ve achieved success as a physician.”

“I’m still working toward that,” he said. “The end goal should sometimes be, less is more.”
 

COPD patients overprescribed home oxygen

In addition to medications, home oxygen therapy is often prescribed when patients are discharged from the hospital.

A study of 69 patients who were continued on home oxygen therapy after hospitalization for an exacerbation of chronic obstructive pulmonary disease was presented by Analisa Taylor, MD, from the University of Illinois at Chicago.

Despite guideline recommendations that patients be reassessed within 90 days of discharge, only 38 patients in the cohort were reassessed, and “28 were considered eligible for discontinuation,” she said during her presentation.

However, “of those, only four were ultimately discontinued,” she reported.

The reason for this gap needs to be examined, noted Dr. Taylor, suggesting that “perhaps clinical inertia plays a role in the continuation of previously prescribed therapy despite a lack of ongoing clinical benefit.”

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

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

In patients with intermediate-risk pulmonary arterial hypertension (PAH) who are not at treatment goal on standard therapy, switching to riociguat is a promising strategy across a broad range of patient subgroups, an investigator said at the annual meeting of the American College of Chest Physicians, held virtually this year.

Patients switching to riociguat in the REPLACE study more frequently met the primary efficacy endpoint, compared with patients who remained on a phosphodiesterase-5 (PDE5) inhibitor, said Marius M. Hoeper, MD, of the Clinic for Respiratory Medicine at Hannover (Germany) Medical School.

That clinical benefit of switching to riociguat, a soluble guanylate cyclase (sGC) stimulator, was relatively consistent across patient subgroups including age, sex, PAH subtype, according to Dr. Hoeper.

“At the end of the day, we believe that switching from a PDE5 inhibitor to riociguat can benefit patients with PAH at intermediate risk and may serve as a new strategic option for treatment escalation,” he said in a live virtual presentation of the study results.

About 40% of patients switching to riociguat met the primary endpoint of clinical improvement in absence of clinical worsening versus just 20% of patients who stayed on a PDE5 inhibitor, according to top-line results of the phase 4 REPLACE study, which were reported Sept. 7 at the annual meeting of the European Respiratory Society.

Results of REPLACE presented at the CHEST meeting show a benefit across most patient subgroups, including PAH subtype and whether patients came from monotherapy or combination treatment to riociguat. Some groups did not appear to respond quite as well to switching, including elderly patients, patients with a 6-minute walk distance (6MWD) of less than 320 meters at baseline, and patients switching from tadalafil as opposed to sildenafil. However, these findings were not statistically significant and may have been chance findings, according to Dr. Hoeper.

These results of REPLACE suggest the efficacy of riociguat “across the board” for intermediate-risk PAH patients with inadequate response to standard therapy, said Vijay Balasubramanian, MD, FCCP, clinical professor of medicine at the University of California San Francisco, Fresno.

Based on REPLACE results, switching from a PDE5 inhibitor to riociguat is now a “strong potential option” beyond adding a third drug such as selexipag or an inhaled prostacyclin to usual treatment with a PDE5 inhibitor plus an endothelin receptor antagonist, Dr. Balasubramanian said in an interview.

“We now have an evidence-based option where you can stay on a two-drug regimen and see whether the switch would work just as well,” said Dr. Balasubramanian, vice chair of the Pulmonary Vascular Disease Steering Committee for the American College of Chest Physicians.

REPLACE is a randomized phase 4 study including 226 patients with PAH considered to be at intermediate risk according to World Health Organization functional class III or 6MWD of 165-440 meters. The composite primary endpoint was defined as no clinical worsening (death, disease progression, or hospitalization for worsening PAH) plus clinical improvement on at least two measures including an improvement in 6MWD, achieving WHO functional class I/II, or a decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP).

The primary endpoint of REPLACE was met, showing that 45 patients (41%) who switched to riociguat had clinical improvement without clinical worsening versus 22 patient (20%) who stayed on the PDE5 inhibitor (odds ratio, 2.78; 95% confidence interval, 1.53-5.06; P = .0007), Dr. Hoeper reported.

The benefit appeared consistent across PAH subgroups, according to Dr. Hoeper. In patients with idiopathic, heritable, or drug- and toxin-induced PAH, the primary endpoint favored riociguat over PDE5 inhibitor, at 45% and 23%, respectively. Similarly, a higher proportion of patients with PAH associated with congenital heart disease or portal hypertension achieved the primary endpoint (46% vs. 8%), as did patients with PAH associated with connective tissue disease (25% vs. 16%).

Adverse events were seen in 71% of riociguat-treated patients and 66% of PDE5 inhibitor–treated patients, according to Dr. Hoeper, who said severe adverse events were more frequent with PDE5-inhibitor treatment, at 17% versus 7% for riociguat. There were three clinical worsening events in the PDE5 inhibitor group leading to death, while a fourth patient died in safety follow-up, according to the reported results, whereas there were no deaths reported with riociguat.

The REPLACE study was cofunded by Bayer AG and Merck Sharpe & Dohme, a subsidiary of Merck & Co. Dr. Hoeper reported receiving fees for consultations or lectures from Acceleron, Actelion, Bayer AG, Janssen, MSD, and Pfizer.

SOURCE: Hoeper MM. CHEST 2020, Abstract A2156-A2159.

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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

A new scoring system can predict whether COVID-19 patients will require invasive mechanical ventilation, researchers report.

The score uses three variables to predict future risk: heart rate; the ratio of oxygen saturation (SpO₂) to fraction of inspired oxygen (FiO₂); and a positive troponin I level.

“What excites us is it’s a really benign tool,” said Muhtadi Alnababteh, MD, from the Medstar Washington (D.C.) Hospital Center. “For the first two variables you only need to look at vital signs, no labs or invasive diagnostics.”

“The third part is a simple lab, which is performed universally and can be done in any hospital,” he told this news organization. “We know that even rural hospitals can do this.”

For their retrospective analysis, Dr. Alnababteh and his colleagues assessed 265 adults with confirmed COVID-19 infection who were admitted to a single tertiary care center in March and April. They looked at demographic characteristics, lab results, and clinical and outcome information.

Ultimately, 54 of these patients required invasive mechanical ventilation.

On multiple-regression analysis, the researchers determined that three variables independently predicted the need for invasive mechanical ventilation.

Existing scores evaluated for COVID-19 outcome prediction

The MuLBSTA score can also be used to predict outcomes in patients with COVID-19.

A retrospective evaluation of 163 patients was presented at CHEST 2020 by Jurgena Tusha, MD, from Wayne State University in Detroit.

Patients who survived their illness had a mean MuLBSTA score of 8.67, whereas patients who died had a mean score of 13.60.

The score “correlated significantly with mortality, ventilator support, and length of stay, which may be used to provide guidance to screen patients and make further clinical decisions,” Dr. Tusha said in a press release.

“Further studies are required to validate this study in larger patient cohorts,” she added.

The three-variable scoring system is easier to use than the MuLBSTA, and more specific, said Dr. Alnababteh.

“The main difference between our study and the MuLBSTA study is that we came up with a novel score for COVID-19 patients,” he said. “Our study score doesn’t require chest x-rays or blood cultures, and the outcome is need for invasive mechanical ventilation, not mortality.”

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