Marcia Frellick

The pandemic exacerbated the financial struggles of many primary care practices, and some still have not recovered from COVID-19–related losses, according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).

Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.

Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.

PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.

Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.

“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”

COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.

Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.

In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”

The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.

Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”


 

End to paycheck protection hurt practices

Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.

“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.

Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.

His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.

“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.

The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.

“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”

Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.

Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.

Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
 

COVID-19 brought ‘accelerated change’

COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.

Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.

A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.

From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.

Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.

One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”

According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.

These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.

Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
 

Uncertainty around telemedicine

A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.

In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.

Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.

In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.

“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.

If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
 

Possible safety nets

Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.

The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.

“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”

Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.

The pandemic exacerbated the financial struggles of many primary care practices, and some still have not recovered from COVID-19–related losses, according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).

Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.

Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.

PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.

Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.

“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”

COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.

Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.

In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”

The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.

Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”


 

End to paycheck protection hurt practices

Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.

“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.

Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.

His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.

“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.

The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.

“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”

Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.

Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.

Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
 

COVID-19 brought ‘accelerated change’

COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.

Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.

A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.

From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.

Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.

One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”

According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.

These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.

Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
 

Uncertainty around telemedicine

A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.

In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.

Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.

In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.

“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.

If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
 

Possible safety nets

Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.

The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.

“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”

Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.

The pandemic exacerbated the financial struggles of many primary care practices, and some still have not recovered from COVID-19–related losses, according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).

Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.

Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.

PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.

Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.

“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”

COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.

Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.

In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”

The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.

Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”


 

End to paycheck protection hurt practices

Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.

“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.

Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.

His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.

“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.

The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.

“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”

Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.

Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.

Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
 

COVID-19 brought ‘accelerated change’

COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.

Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.

A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.

From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.

Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.

One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”

According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.

These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.

Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
 

Uncertainty around telemedicine

A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.

In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.

Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.

In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.

“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.

If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
 

Possible safety nets

Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.

The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.

“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”

Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

• Increase federal funding to ensure all families can access mental health services.
• Improve access to telemedicine.
• Accelerate integration of mental health care in pediatric primary care.
• Fully fund community-based systems of care that connect families to evidence-based interventions.
• Promote and pay for trauma-informed care services.
• Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

• Increase federal funding to ensure all families can access mental health services.
• Improve access to telemedicine.
• Accelerate integration of mental health care in pediatric primary care.
• Fully fund community-based systems of care that connect families to evidence-based interventions.
• Promote and pay for trauma-informed care services.
• Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

• Increase federal funding to ensure all families can access mental health services.
• Improve access to telemedicine.
• Accelerate integration of mental health care in pediatric primary care.
• Fully fund community-based systems of care that connect families to evidence-based interventions.
• Promote and pay for trauma-informed care services.
• Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

The chances that unvaccinated family members will be infected or hospitalized with COVID-19 drop sharply if even one family member is vaccinated. The chances are reduced even further with each additional vaccinated or otherwise immune family member, according to new data.

Lead author Peter Nordström, MD, PhD, with the unit of geriatric medicine, Umeå (Sweden) University, said in an interview the message is important for public health: “When you vaccinate, you do not just protect yourself but also your relatives.”

The findings were published online on Oct. 11, 2021, in JAMA Internal Medicine.

Researchers analyzed data from 1,789,728 individuals from 814,806 families from nationwide registries in Sweden. All individuals had acquired immunity either from previously being infected with SARS-CoV-2 or by being fully vaccinated (that is, having received two doses of the Moderna, Pfizer, or Oxford/AstraZeneca vaccines). Persons were considered for inclusion until May 26, 2021.

Each person with immunity was matched in a 1:1 ratio to a person without immunity from a cohort of individuals with families that had from two to five members. Families with more than five members were excluded because of small sample sizes.

Primarily nonimmune families in which there was one immune family member had a 45%-61% lower risk of contracting COVID-19 (hazard ratio, 0.39-0.55; 95% confidence interval, 0.37-0.61; P < .001).

The risk reduction increased to 75%-86% when two family members were immune (HR, 0.14-0.25; 95% CI, 0.11-0.27; P < .001).

It increased to 91%-94% when three family members were immune (HR, 0.06-0.09; 95% CI, 0.04-0.10; P < .001) and to 97% with four immune family members (HR, 0.03; 95% CI, 0.02-0.05; P < .001).

“The results were similar for the outcome of COVID-19 infection that was severe enough to warrant a hospital stay,” the authors wrote. They listed as an example that, in three-member families in which two members were immune, the remaining nonimmune family member had an 80% lower risk for hospitalization (HR, 0.20; 95% CI, 0.10-0.43; P < .001).
 

Global implications

Dr. Nordström said the team used the family setting because it was more easily identifiable as a cohort with the national registries and because COVID-19 is spread among people in close contact with each other. The findings have implications for other groups that spend large amounts of time together and for herd immunity, he added.

The findings may be particularly welcome in regions of the world where vaccination rates are very low. The authors noted that most of the global population has not yet been vaccinated and that “it is anticipated that most of the population in low-income countries will be unable to receive a vaccine in 2021, with current vaccination rates suggesting that completely inoculating 70%-85% of the global population may take up to 5 years.”

Jill Foster, MD, a pediatric infectious disease specialist at the University of Minnesota, Minneapolis, said in an interview she agrees that the news could encourage countries that have very low vaccination rates.

This study may help motivate areas with few resources to start small, she said: “Even one is better than zero.”

She added that this news could also help ease the minds of families that have immunocompromised members or in which there are children who are too young to be vaccinated.

With these data, she said, people can see there’s something they can do to help protect a family member.

Dr. Foster said that although it’s intuitive to think that the more vaccinated people there are in a family, the safer people are, “it’s really nice to see the data coming out of such a large dataset.”

The authors acknowledged that a limitation of the study is that, at the time the study was conducted, the Delta variant was uncommon in Sweden. It is therefore unclear whether the findings regarding immunity are still relevant in Sweden and elsewhere now that the Delta strain is dominant.

The authors reported no relevant financial relationships. Dr. Foster has received grant support from Moderna.

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

The chances that unvaccinated family members will be infected or hospitalized with COVID-19 drop sharply if even one family member is vaccinated. The chances are reduced even further with each additional vaccinated or otherwise immune family member, according to new data.

Lead author Peter Nordström, MD, PhD, with the unit of geriatric medicine, Umeå (Sweden) University, said in an interview the message is important for public health: “When you vaccinate, you do not just protect yourself but also your relatives.”

The findings were published online on Oct. 11, 2021, in JAMA Internal Medicine.

Researchers analyzed data from 1,789,728 individuals from 814,806 families from nationwide registries in Sweden. All individuals had acquired immunity either from previously being infected with SARS-CoV-2 or by being fully vaccinated (that is, having received two doses of the Moderna, Pfizer, or Oxford/AstraZeneca vaccines). Persons were considered for inclusion until May 26, 2021.

Each person with immunity was matched in a 1:1 ratio to a person without immunity from a cohort of individuals with families that had from two to five members. Families with more than five members were excluded because of small sample sizes.

Primarily nonimmune families in which there was one immune family member had a 45%-61% lower risk of contracting COVID-19 (hazard ratio, 0.39-0.55; 95% confidence interval, 0.37-0.61; P < .001).

The risk reduction increased to 75%-86% when two family members were immune (HR, 0.14-0.25; 95% CI, 0.11-0.27; P < .001).

It increased to 91%-94% when three family members were immune (HR, 0.06-0.09; 95% CI, 0.04-0.10; P < .001) and to 97% with four immune family members (HR, 0.03; 95% CI, 0.02-0.05; P < .001).

“The results were similar for the outcome of COVID-19 infection that was severe enough to warrant a hospital stay,” the authors wrote. They listed as an example that, in three-member families in which two members were immune, the remaining nonimmune family member had an 80% lower risk for hospitalization (HR, 0.20; 95% CI, 0.10-0.43; P < .001).
 

Global implications

Dr. Nordström said the team used the family setting because it was more easily identifiable as a cohort with the national registries and because COVID-19 is spread among people in close contact with each other. The findings have implications for other groups that spend large amounts of time together and for herd immunity, he added.

The findings may be particularly welcome in regions of the world where vaccination rates are very low. The authors noted that most of the global population has not yet been vaccinated and that “it is anticipated that most of the population in low-income countries will be unable to receive a vaccine in 2021, with current vaccination rates suggesting that completely inoculating 70%-85% of the global population may take up to 5 years.”

Jill Foster, MD, a pediatric infectious disease specialist at the University of Minnesota, Minneapolis, said in an interview she agrees that the news could encourage countries that have very low vaccination rates.

This study may help motivate areas with few resources to start small, she said: “Even one is better than zero.”

She added that this news could also help ease the minds of families that have immunocompromised members or in which there are children who are too young to be vaccinated.

With these data, she said, people can see there’s something they can do to help protect a family member.

Dr. Foster said that although it’s intuitive to think that the more vaccinated people there are in a family, the safer people are, “it’s really nice to see the data coming out of such a large dataset.”

The authors acknowledged that a limitation of the study is that, at the time the study was conducted, the Delta variant was uncommon in Sweden. It is therefore unclear whether the findings regarding immunity are still relevant in Sweden and elsewhere now that the Delta strain is dominant.

The authors reported no relevant financial relationships. Dr. Foster has received grant support from Moderna.

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

The chances that unvaccinated family members will be infected or hospitalized with COVID-19 drop sharply if even one family member is vaccinated. The chances are reduced even further with each additional vaccinated or otherwise immune family member, according to new data.

Lead author Peter Nordström, MD, PhD, with the unit of geriatric medicine, Umeå (Sweden) University, said in an interview the message is important for public health: “When you vaccinate, you do not just protect yourself but also your relatives.”

The findings were published online on Oct. 11, 2021, in JAMA Internal Medicine.

Researchers analyzed data from 1,789,728 individuals from 814,806 families from nationwide registries in Sweden. All individuals had acquired immunity either from previously being infected with SARS-CoV-2 or by being fully vaccinated (that is, having received two doses of the Moderna, Pfizer, or Oxford/AstraZeneca vaccines). Persons were considered for inclusion until May 26, 2021.

Each person with immunity was matched in a 1:1 ratio to a person without immunity from a cohort of individuals with families that had from two to five members. Families with more than five members were excluded because of small sample sizes.

Primarily nonimmune families in which there was one immune family member had a 45%-61% lower risk of contracting COVID-19 (hazard ratio, 0.39-0.55; 95% confidence interval, 0.37-0.61; P < .001).

The risk reduction increased to 75%-86% when two family members were immune (HR, 0.14-0.25; 95% CI, 0.11-0.27; P < .001).

It increased to 91%-94% when three family members were immune (HR, 0.06-0.09; 95% CI, 0.04-0.10; P < .001) and to 97% with four immune family members (HR, 0.03; 95% CI, 0.02-0.05; P < .001).

“The results were similar for the outcome of COVID-19 infection that was severe enough to warrant a hospital stay,” the authors wrote. They listed as an example that, in three-member families in which two members were immune, the remaining nonimmune family member had an 80% lower risk for hospitalization (HR, 0.20; 95% CI, 0.10-0.43; P < .001).
 

Global implications

Dr. Nordström said the team used the family setting because it was more easily identifiable as a cohort with the national registries and because COVID-19 is spread among people in close contact with each other. The findings have implications for other groups that spend large amounts of time together and for herd immunity, he added.

The findings may be particularly welcome in regions of the world where vaccination rates are very low. The authors noted that most of the global population has not yet been vaccinated and that “it is anticipated that most of the population in low-income countries will be unable to receive a vaccine in 2021, with current vaccination rates suggesting that completely inoculating 70%-85% of the global population may take up to 5 years.”

Jill Foster, MD, a pediatric infectious disease specialist at the University of Minnesota, Minneapolis, said in an interview she agrees that the news could encourage countries that have very low vaccination rates.

This study may help motivate areas with few resources to start small, she said: “Even one is better than zero.”

She added that this news could also help ease the minds of families that have immunocompromised members or in which there are children who are too young to be vaccinated.

With these data, she said, people can see there’s something they can do to help protect a family member.

Dr. Foster said that although it’s intuitive to think that the more vaccinated people there are in a family, the safer people are, “it’s really nice to see the data coming out of such a large dataset.”

The authors acknowledged that a limitation of the study is that, at the time the study was conducted, the Delta variant was uncommon in Sweden. It is therefore unclear whether the findings regarding immunity are still relevant in Sweden and elsewhere now that the Delta strain is dominant.

The authors reported no relevant financial relationships. Dr. Foster has received grant support from Moderna.

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

High-efficiency particulate air (HEPA) filters and ultraviolet (UV) light sterilization effectively remove SARS-CoV-2 particles from the air — the first such evidence in a real-world test, researchers report in the preprint server medRxiv.

The journal Nature reported Oct. 6 that the research, which has not been peer-reviewed, suggests the filters may help reduce the risk of hospital-acquired SARS-CoV-2.

Researchers, led by intensivist Andrew Conway-Morris, MBChB, PhD, with the division of anaesthesia in the school of clinical medicine at University of Cambridge, United Kingdom, write that earlier experiments assessed air filters’ ability to remove inactive particles in carefully controlled environments, but it was unknown how they would work in a real-world setting.

Co-author Vilas Navapurkar, MBChB, an ICU physician at Addenbrooke’s Hospital in Cambridge, United Kingdom, said that hospitals have used portable air filters when their isolation facilities are full, but evidence was needed as to whether such filters are effective or whether they provide a false sense of security.

The researchers installed the filters in two fully occupied COVID-19 wards — a general ward and an ICU. They chose HEPA filters because they can catch extremely small particles.

The team collected air samples from the wards during a week when the air filters were on and 2 weeks when they were turned off, then compared results.

According to the study, “airborne SARS-CoV-2 was detected in the ward on all five days before activation of air/UV filtration, but on none of the five days when the air/UV filter was operational; SARS-CoV-2 was again detected on four out of five days when the filter was off.”

Airborne SARS-CoV-2 was not frequently detected in the ICU, even when the filters were off.

Cheap and easy

According to the Nature article, the authors suggest several potential explanations for this, “including slower viral replication at later stages of the disease.” Therefore, the authors say, filtering the virus from the air might be more important in general wards than in ICUs.

The filters significantly reduced the other microbial bioaerosols in both the ward (48 pathogens detected before filtration, 2 after, P = .05) and the ICU (45 pathogens detected before filtration, 5 after P = .05).

National Institute for Occupational Safety and Health (NIOSH) cyclonic aerosol samplers and PCR tests were used to detect airborne SARS-CoV-2 and other microbial bioaerosol.

David Fisman, MD, an epidemiologist at the University of Toronto, who was not involved in the research, said in the Nature article, “This study suggests that HEPA air cleaners, which remain little-used in Canadian hospitals, are a cheap and easy way to reduce risk from airborne pathogens.”This work was supported by a Wellcome senior research fellowship to co-author Stephen Baker. Conway Morris is supported by a Clinician Scientist Fellowship from the Medical Research Council. Dr. Navapurkar is the founder, director, and shareholder of Cambridge Infection Diagnostics Ltd. Dr. Conway-Morris and several co-authors are members of the Scientific Advisory Board of Cambridge Infection Diagnostics Ltd. Co-author Theodore Gouliouris has received a research grant from Shionogi and co-author R. Andres Floto has received research grants and/or consultancy payments from GSK, AstraZeneca, Chiesi, Shionogi, Insmed, and Thirty Technology.

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

High-efficiency particulate air (HEPA) filters and ultraviolet (UV) light sterilization effectively remove SARS-CoV-2 particles from the air — the first such evidence in a real-world test, researchers report in the preprint server medRxiv.

The journal Nature reported Oct. 6 that the research, which has not been peer-reviewed, suggests the filters may help reduce the risk of hospital-acquired SARS-CoV-2.

Researchers, led by intensivist Andrew Conway-Morris, MBChB, PhD, with the division of anaesthesia in the school of clinical medicine at University of Cambridge, United Kingdom, write that earlier experiments assessed air filters’ ability to remove inactive particles in carefully controlled environments, but it was unknown how they would work in a real-world setting.

Co-author Vilas Navapurkar, MBChB, an ICU physician at Addenbrooke’s Hospital in Cambridge, United Kingdom, said that hospitals have used portable air filters when their isolation facilities are full, but evidence was needed as to whether such filters are effective or whether they provide a false sense of security.

The researchers installed the filters in two fully occupied COVID-19 wards — a general ward and an ICU. They chose HEPA filters because they can catch extremely small particles.

The team collected air samples from the wards during a week when the air filters were on and 2 weeks when they were turned off, then compared results.

According to the study, “airborne SARS-CoV-2 was detected in the ward on all five days before activation of air/UV filtration, but on none of the five days when the air/UV filter was operational; SARS-CoV-2 was again detected on four out of five days when the filter was off.”

Airborne SARS-CoV-2 was not frequently detected in the ICU, even when the filters were off.

Cheap and easy

According to the Nature article, the authors suggest several potential explanations for this, “including slower viral replication at later stages of the disease.” Therefore, the authors say, filtering the virus from the air might be more important in general wards than in ICUs.

The filters significantly reduced the other microbial bioaerosols in both the ward (48 pathogens detected before filtration, 2 after, P = .05) and the ICU (45 pathogens detected before filtration, 5 after P = .05).

National Institute for Occupational Safety and Health (NIOSH) cyclonic aerosol samplers and PCR tests were used to detect airborne SARS-CoV-2 and other microbial bioaerosol.

David Fisman, MD, an epidemiologist at the University of Toronto, who was not involved in the research, said in the Nature article, “This study suggests that HEPA air cleaners, which remain little-used in Canadian hospitals, are a cheap and easy way to reduce risk from airborne pathogens.”This work was supported by a Wellcome senior research fellowship to co-author Stephen Baker. Conway Morris is supported by a Clinician Scientist Fellowship from the Medical Research Council. Dr. Navapurkar is the founder, director, and shareholder of Cambridge Infection Diagnostics Ltd. Dr. Conway-Morris and several co-authors are members of the Scientific Advisory Board of Cambridge Infection Diagnostics Ltd. Co-author Theodore Gouliouris has received a research grant from Shionogi and co-author R. Andres Floto has received research grants and/or consultancy payments from GSK, AstraZeneca, Chiesi, Shionogi, Insmed, and Thirty Technology.

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

High-efficiency particulate air (HEPA) filters and ultraviolet (UV) light sterilization effectively remove SARS-CoV-2 particles from the air — the first such evidence in a real-world test, researchers report in the preprint server medRxiv.

The journal Nature reported Oct. 6 that the research, which has not been peer-reviewed, suggests the filters may help reduce the risk of hospital-acquired SARS-CoV-2.

Researchers, led by intensivist Andrew Conway-Morris, MBChB, PhD, with the division of anaesthesia in the school of clinical medicine at University of Cambridge, United Kingdom, write that earlier experiments assessed air filters’ ability to remove inactive particles in carefully controlled environments, but it was unknown how they would work in a real-world setting.

Co-author Vilas Navapurkar, MBChB, an ICU physician at Addenbrooke’s Hospital in Cambridge, United Kingdom, said that hospitals have used portable air filters when their isolation facilities are full, but evidence was needed as to whether such filters are effective or whether they provide a false sense of security.

The researchers installed the filters in two fully occupied COVID-19 wards — a general ward and an ICU. They chose HEPA filters because they can catch extremely small particles.

The team collected air samples from the wards during a week when the air filters were on and 2 weeks when they were turned off, then compared results.

According to the study, “airborne SARS-CoV-2 was detected in the ward on all five days before activation of air/UV filtration, but on none of the five days when the air/UV filter was operational; SARS-CoV-2 was again detected on four out of five days when the filter was off.”

Airborne SARS-CoV-2 was not frequently detected in the ICU, even when the filters were off.

Cheap and easy

According to the Nature article, the authors suggest several potential explanations for this, “including slower viral replication at later stages of the disease.” Therefore, the authors say, filtering the virus from the air might be more important in general wards than in ICUs.

The filters significantly reduced the other microbial bioaerosols in both the ward (48 pathogens detected before filtration, 2 after, P = .05) and the ICU (45 pathogens detected before filtration, 5 after P = .05).

National Institute for Occupational Safety and Health (NIOSH) cyclonic aerosol samplers and PCR tests were used to detect airborne SARS-CoV-2 and other microbial bioaerosol.

David Fisman, MD, an epidemiologist at the University of Toronto, who was not involved in the research, said in the Nature article, “This study suggests that HEPA air cleaners, which remain little-used in Canadian hospitals, are a cheap and easy way to reduce risk from airborne pathogens.”This work was supported by a Wellcome senior research fellowship to co-author Stephen Baker. Conway Morris is supported by a Clinician Scientist Fellowship from the Medical Research Council. Dr. Navapurkar is the founder, director, and shareholder of Cambridge Infection Diagnostics Ltd. Dr. Conway-Morris and several co-authors are members of the Scientific Advisory Board of Cambridge Infection Diagnostics Ltd. Co-author Theodore Gouliouris has received a research grant from Shionogi and co-author R. Andres Floto has received research grants and/or consultancy payments from GSK, AstraZeneca, Chiesi, Shionogi, Insmed, and Thirty Technology.

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

The common-cold viruses rhinovirus (RV) and enterovirus (EV) continued to circulate among children during the COVID-19 pandemic while there were sharp declines in influenza, respiratory syncytial virus (RSV), and other respiratory viruses, new data indicate.

Researchers used data from the Centers for Disease Control and Prevention’s New Vaccine Surveillance Network. The cases involved 37,676 children in seven geographically diverse U.S. medical centers between December 2016 and January 2021. Patients presented to emergency departments or were hospitalized with RV, EV, and other acute respiratory viruses.

The investigators found that the percentage of children in whom RV/EV was detected from March 2020 to January 2021 was similar to the percentage during the same months in 2017-2018 and 2019-2020. However, the proportion of children infected with influenza, RSV, and other respiratory viruses combined dropped significantly in comparison to the three prior seasons.

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

The common-cold viruses rhinovirus (RV) and enterovirus (EV) continued to circulate among children during the COVID-19 pandemic while there were sharp declines in influenza, respiratory syncytial virus (RSV), and other respiratory viruses, new data indicate.

Researchers used data from the Centers for Disease Control and Prevention’s New Vaccine Surveillance Network. The cases involved 37,676 children in seven geographically diverse U.S. medical centers between December 2016 and January 2021. Patients presented to emergency departments or were hospitalized with RV, EV, and other acute respiratory viruses.

The investigators found that the percentage of children in whom RV/EV was detected from March 2020 to January 2021 was similar to the percentage during the same months in 2017-2018 and 2019-2020. However, the proportion of children infected with influenza, RSV, and other respiratory viruses combined dropped significantly in comparison to the three prior seasons.

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

The common-cold viruses rhinovirus (RV) and enterovirus (EV) continued to circulate among children during the COVID-19 pandemic while there were sharp declines in influenza, respiratory syncytial virus (RSV), and other respiratory viruses, new data indicate.

Researchers used data from the Centers for Disease Control and Prevention’s New Vaccine Surveillance Network. The cases involved 37,676 children in seven geographically diverse U.S. medical centers between December 2016 and January 2021. Patients presented to emergency departments or were hospitalized with RV, EV, and other acute respiratory viruses.

The investigators found that the percentage of children in whom RV/EV was detected from March 2020 to January 2021 was similar to the percentage during the same months in 2017-2018 and 2019-2020. However, the proportion of children infected with influenza, RSV, and other respiratory viruses combined dropped significantly in comparison to the three prior seasons.

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

A one-time dose of two long-acting monoclonal antibodies reduced the risk of developing symptomatic COVID by 77% in comparison with placebo (P < .001) in a randomized, double-blind, placebo-controlled, phase 3 trial in adults, according to researchers who presented results at IDWeek 2021, an annual scientific meeting on infectious diseases.

The mix of tixagevimab and cilgavimab (AZD7442, Astra Zeneca) in a 300-mg dose is delivered in two intramuscular injections.

“This is the first long-acting combination of monoclonal antibodies that represents a potential new option to augment COVID-19 prevention,” said lead author Myron J. Levin, MD, a professor and pediatric infectious disease specialist at the University of Colorado at Denver, Aurora, who presented the findings of the PROVENT trial.

Both antibodies were taken from B cells donated by patients who had been infected with SARS-CoV-2, and they work synergistically, Dr. Levin said.

“The combination of them is better than adding results of each individually,” he said. “In vitro experiments have already shown that variants of interest and concern, including the Delta variant, are successfully neutralized by this cocktail.”

The trial was conducted in 87 sites in the United States, the United Kingdom, Spain, France, and Belgium. Participants included 5,197 unvaccinated adults who had never been infected with SARS-CoV-2 and either were at higher risk for inadequate response to COVID-19 vaccines because they were immunocompromised or were at high risk for exposure.

“Efficacy was observed through at least 3 months,” Dr. Levin said. “Preliminary pharmacokinetic modeling predicts potential protection for up to 12 months.”

Raymund Razonable, MD, an infectious disease expert with the Mayo Clinic in Rochester, Minn., who was not involved with the trial, told this news organization he was particularly interested in this combination because the developers made use of novel technology that extends the half-life of the antibodies and because of the large number of participants in the study.

Modeling that shows protection could last up to a year is novel and important, he said.

“People won’t need frequent injections,” Dr. Razonable said. With postexposure prophylaxis monoclonal cocktails, people may be given a dose a month, he noted.

Dr. Razonable said, “This is something intended to prevent COVID in people who are unvaccinated. The downside to that is we want people to get vaccinated. The best strategy so far is really vaccination.”

He said AZD7442 could potentially help fill the void for patients who are not able to respond to the COVID vaccines, including some who are immunocompromised or are undergoing chemotherapy.

Dr. Razonable said that, although the 77% reduction for developing symptomatic COVID-19 (95% confidence interval vs. placebo, 46.0-90.0; P < .001) is impressive, it is a reduction in relative risk. Still unknown is how much an individual’s absolute risk is reduced.

He also said it would be helpful to know how many people in the study population were immunocompromised, “because I think that’s where this product will be useful for prevention.”

The primary study endpoints were the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness post dose and prior to day 183 (efficacy) as well as the safety of the product.

The cocktail appeared to be well tolerated. Adverse events occurred in 35% of participants administered AZD7442 and in 34% of the placebo group. Injection-site reactions occurred in 2.4% of the AZD7442 group and in 2.1% of the placebo group. There was one case of severe or critical COVID-19; two COVID-19–related deaths occurred in the placebo group.

AZD7442 is being developed with the help of funding from the U.S. government. Dr. Levin has received support from GlaxoSmithKline companies. Many of the coauthors are employed by AstraZeneca and hold stock in the company. Dr. Razonable has disclosed no relevant financial relationships.

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

A one-time dose of two long-acting monoclonal antibodies reduced the risk of developing symptomatic COVID by 77% in comparison with placebo (P < .001) in a randomized, double-blind, placebo-controlled, phase 3 trial in adults, according to researchers who presented results at IDWeek 2021, an annual scientific meeting on infectious diseases.

The mix of tixagevimab and cilgavimab (AZD7442, Astra Zeneca) in a 300-mg dose is delivered in two intramuscular injections.

“This is the first long-acting combination of monoclonal antibodies that represents a potential new option to augment COVID-19 prevention,” said lead author Myron J. Levin, MD, a professor and pediatric infectious disease specialist at the University of Colorado at Denver, Aurora, who presented the findings of the PROVENT trial.

Both antibodies were taken from B cells donated by patients who had been infected with SARS-CoV-2, and they work synergistically, Dr. Levin said.

“The combination of them is better than adding results of each individually,” he said. “In vitro experiments have already shown that variants of interest and concern, including the Delta variant, are successfully neutralized by this cocktail.”

The trial was conducted in 87 sites in the United States, the United Kingdom, Spain, France, and Belgium. Participants included 5,197 unvaccinated adults who had never been infected with SARS-CoV-2 and either were at higher risk for inadequate response to COVID-19 vaccines because they were immunocompromised or were at high risk for exposure.

“Efficacy was observed through at least 3 months,” Dr. Levin said. “Preliminary pharmacokinetic modeling predicts potential protection for up to 12 months.”

Raymund Razonable, MD, an infectious disease expert with the Mayo Clinic in Rochester, Minn., who was not involved with the trial, told this news organization he was particularly interested in this combination because the developers made use of novel technology that extends the half-life of the antibodies and because of the large number of participants in the study.

Modeling that shows protection could last up to a year is novel and important, he said.

“People won’t need frequent injections,” Dr. Razonable said. With postexposure prophylaxis monoclonal cocktails, people may be given a dose a month, he noted.

Dr. Razonable said, “This is something intended to prevent COVID in people who are unvaccinated. The downside to that is we want people to get vaccinated. The best strategy so far is really vaccination.”

He said AZD7442 could potentially help fill the void for patients who are not able to respond to the COVID vaccines, including some who are immunocompromised or are undergoing chemotherapy.

Dr. Razonable said that, although the 77% reduction for developing symptomatic COVID-19 (95% confidence interval vs. placebo, 46.0-90.0; P < .001) is impressive, it is a reduction in relative risk. Still unknown is how much an individual’s absolute risk is reduced.

He also said it would be helpful to know how many people in the study population were immunocompromised, “because I think that’s where this product will be useful for prevention.”

The primary study endpoints were the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness post dose and prior to day 183 (efficacy) as well as the safety of the product.

The cocktail appeared to be well tolerated. Adverse events occurred in 35% of participants administered AZD7442 and in 34% of the placebo group. Injection-site reactions occurred in 2.4% of the AZD7442 group and in 2.1% of the placebo group. There was one case of severe or critical COVID-19; two COVID-19–related deaths occurred in the placebo group.

AZD7442 is being developed with the help of funding from the U.S. government. Dr. Levin has received support from GlaxoSmithKline companies. Many of the coauthors are employed by AstraZeneca and hold stock in the company. Dr. Razonable has disclosed no relevant financial relationships.

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

A one-time dose of two long-acting monoclonal antibodies reduced the risk of developing symptomatic COVID by 77% in comparison with placebo (P < .001) in a randomized, double-blind, placebo-controlled, phase 3 trial in adults, according to researchers who presented results at IDWeek 2021, an annual scientific meeting on infectious diseases.

The mix of tixagevimab and cilgavimab (AZD7442, Astra Zeneca) in a 300-mg dose is delivered in two intramuscular injections.

“This is the first long-acting combination of monoclonal antibodies that represents a potential new option to augment COVID-19 prevention,” said lead author Myron J. Levin, MD, a professor and pediatric infectious disease specialist at the University of Colorado at Denver, Aurora, who presented the findings of the PROVENT trial.

Both antibodies were taken from B cells donated by patients who had been infected with SARS-CoV-2, and they work synergistically, Dr. Levin said.

“The combination of them is better than adding results of each individually,” he said. “In vitro experiments have already shown that variants of interest and concern, including the Delta variant, are successfully neutralized by this cocktail.”

The trial was conducted in 87 sites in the United States, the United Kingdom, Spain, France, and Belgium. Participants included 5,197 unvaccinated adults who had never been infected with SARS-CoV-2 and either were at higher risk for inadequate response to COVID-19 vaccines because they were immunocompromised or were at high risk for exposure.

“Efficacy was observed through at least 3 months,” Dr. Levin said. “Preliminary pharmacokinetic modeling predicts potential protection for up to 12 months.”

Raymund Razonable, MD, an infectious disease expert with the Mayo Clinic in Rochester, Minn., who was not involved with the trial, told this news organization he was particularly interested in this combination because the developers made use of novel technology that extends the half-life of the antibodies and because of the large number of participants in the study.

Modeling that shows protection could last up to a year is novel and important, he said.

“People won’t need frequent injections,” Dr. Razonable said. With postexposure prophylaxis monoclonal cocktails, people may be given a dose a month, he noted.

Dr. Razonable said, “This is something intended to prevent COVID in people who are unvaccinated. The downside to that is we want people to get vaccinated. The best strategy so far is really vaccination.”

He said AZD7442 could potentially help fill the void for patients who are not able to respond to the COVID vaccines, including some who are immunocompromised or are undergoing chemotherapy.

Dr. Razonable said that, although the 77% reduction for developing symptomatic COVID-19 (95% confidence interval vs. placebo, 46.0-90.0; P < .001) is impressive, it is a reduction in relative risk. Still unknown is how much an individual’s absolute risk is reduced.

He also said it would be helpful to know how many people in the study population were immunocompromised, “because I think that’s where this product will be useful for prevention.”

The primary study endpoints were the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness post dose and prior to day 183 (efficacy) as well as the safety of the product.

The cocktail appeared to be well tolerated. Adverse events occurred in 35% of participants administered AZD7442 and in 34% of the placebo group. Injection-site reactions occurred in 2.4% of the AZD7442 group and in 2.1% of the placebo group. There was one case of severe or critical COVID-19; two COVID-19–related deaths occurred in the placebo group.

AZD7442 is being developed with the help of funding from the U.S. government. Dr. Levin has received support from GlaxoSmithKline companies. Many of the coauthors are employed by AstraZeneca and hold stock in the company. Dr. Razonable has disclosed no relevant financial relationships.

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

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

Two of the three late-breaking abstract sessions coming up this week at IDWeek 2021, an annual scientific meeting on infectious diseases, are filled with the most recent evidence on COVID-19 prevention and treatment.

Adarsh Bhimraj, MD, a vice chair of the conference, said in an interview that attendees will leave the virtual conference with an up-to-date view of what’s promising in the fight against COVID-19 globally and what questions are as yet unanswered.

Researchers will also present findings on promising new antibiotics in the pipeline, stewardship efforts, health disparities, telemedicine advances, and emerging pathogens, but at least a quarter of the program is devoted to COVID-19.

“It’s hard to ignore the elephant in the room,” Dr. Bhimraj said.

Vaccine distribution will be among the hot topics at the global conference, he said, in light of the recent decisions by the Food and Drug Administration and the Centers for Disease Control and Prevention to reserve boosters for those at greatest risk.

Although the United States and other high-resource countries are deciding who should get boosters, only 10% of the developing world has received even a single dose, he noted.

The conference will also present a worldwide view of scientific collaboration to address the COVID pandemic and pandemics yet to come, Dr. Bhimraj said.

He highlighted a talk on Oct. 2, to be delivered by South African human rights attorney and social justice activist Fatima Hassan, called “Global Vaccines and Preventive Care Inequities: Implications and Solutions Beyond the Pandemic.”

The session looks ahead to building systems to share resources and knowledge to end deadly outbreaks with an equitable approach.

“We live in a global village,” Dr. Bhimraj said. “It isn’t just the right thing to do, it’s the pragmatic thing to do.”
 

Controversies in non-COVID diseases

Controversies and new treatments are plentiful in other diseases as well.

• At an HIV session, arguments will be presented regarding the sustainability and practicalities of telemedicine in HIV. Speakers will argue for and against telemedicine as a permanent practice changer for the field.
• In a session on Oct. 1, panelists will discuss pros and cons of information published in preprints versus peer-reviewed journals and how to assess when research findings should lead to practice change.
• Also on Oct. 1, panelists in a symposium will discuss advantages and disadvantages of antifungal treatments for children who have received solid organ transplants.
• Antimicrobial stewardship continues to be a primary topic at IDWeek, this year with additional pandemic challenges. Sessions will address trends in use and diagnostic advances to help in prescribing.
• The pipeline for new antibiotics continues to face barriers regarding production and development. No new classes of antibiotics have been discovered since the 1980s. Pew has that there are too few drugs in development to meet current and anticipated need.
• This year’s program offers a symposium on private-public partnerships to help jump-start development.
• One of the most popular sessions returning this year is “Clinical Trials That Will Change Your Practice,” Dr. Bhimraj said. This year, that session will be reserved for non-COVID infectious disease research. Presenters will summarize the findings of top work published in the past year.

Around-the-world COVID view

Again this year, global experts will present a round-the-clock session called “Chasing the Sun” the day before the main sessions. It will include updates on COVID throughout the world. Barney Graham, MD, PhD, deputy director of the National Institutes of Health’s Vaccine Research Center, will kick off the program with an address on the future of vaccinology. This will be followed by updates on the state of the disease in Central and South America, Japan, Asia Pacific, India, and Africa.

Sandra Harwood, IDWeek conference secretariat, who proposed the idea for the first Chasing the Sun session last year, said in an interview that the updates will highlight particular COVID challenges experienced in various countries.

For example, leaders of India’s session will address why a potentially fatal fungal disease struck many COVID-19 patients in that country. Japan’s update will include how Olympic organizers planned for and dealt with the virus’s threat in Tokyo.

Ms. Harwood said that all the COVID sessions in Chasing the Sun and throughout the program will be free to clinicians inside and outside the conference, thanks to a grant from the CDC.

An address by CDC Director Rochelle Walensky, MD, MPH, on Sept. 30 will wrap up Chasing the Sun and launch the main IDWeek program.

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

Two of the three late-breaking abstract sessions coming up this week at IDWeek 2021, an annual scientific meeting on infectious diseases, are filled with the most recent evidence on COVID-19 prevention and treatment.

Adarsh Bhimraj, MD, a vice chair of the conference, said in an interview that attendees will leave the virtual conference with an up-to-date view of what’s promising in the fight against COVID-19 globally and what questions are as yet unanswered.

Researchers will also present findings on promising new antibiotics in the pipeline, stewardship efforts, health disparities, telemedicine advances, and emerging pathogens, but at least a quarter of the program is devoted to COVID-19.

“It’s hard to ignore the elephant in the room,” Dr. Bhimraj said.

Vaccine distribution will be among the hot topics at the global conference, he said, in light of the recent decisions by the Food and Drug Administration and the Centers for Disease Control and Prevention to reserve boosters for those at greatest risk.

Although the United States and other high-resource countries are deciding who should get boosters, only 10% of the developing world has received even a single dose, he noted.

The conference will also present a worldwide view of scientific collaboration to address the COVID pandemic and pandemics yet to come, Dr. Bhimraj said.

He highlighted a talk on Oct. 2, to be delivered by South African human rights attorney and social justice activist Fatima Hassan, called “Global Vaccines and Preventive Care Inequities: Implications and Solutions Beyond the Pandemic.”

The session looks ahead to building systems to share resources and knowledge to end deadly outbreaks with an equitable approach.

“We live in a global village,” Dr. Bhimraj said. “It isn’t just the right thing to do, it’s the pragmatic thing to do.”
 

Controversies in non-COVID diseases

Controversies and new treatments are plentiful in other diseases as well.

• At an HIV session, arguments will be presented regarding the sustainability and practicalities of telemedicine in HIV. Speakers will argue for and against telemedicine as a permanent practice changer for the field.
• In a session on Oct. 1, panelists will discuss pros and cons of information published in preprints versus peer-reviewed journals and how to assess when research findings should lead to practice change.
• Also on Oct. 1, panelists in a symposium will discuss advantages and disadvantages of antifungal treatments for children who have received solid organ transplants.
• Antimicrobial stewardship continues to be a primary topic at IDWeek, this year with additional pandemic challenges. Sessions will address trends in use and diagnostic advances to help in prescribing.
• The pipeline for new antibiotics continues to face barriers regarding production and development. No new classes of antibiotics have been discovered since the 1980s. Pew has that there are too few drugs in development to meet current and anticipated need.
• This year’s program offers a symposium on private-public partnerships to help jump-start development.
• One of the most popular sessions returning this year is “Clinical Trials That Will Change Your Practice,” Dr. Bhimraj said. This year, that session will be reserved for non-COVID infectious disease research. Presenters will summarize the findings of top work published in the past year.

Around-the-world COVID view

Again this year, global experts will present a round-the-clock session called “Chasing the Sun” the day before the main sessions. It will include updates on COVID throughout the world. Barney Graham, MD, PhD, deputy director of the National Institutes of Health’s Vaccine Research Center, will kick off the program with an address on the future of vaccinology. This will be followed by updates on the state of the disease in Central and South America, Japan, Asia Pacific, India, and Africa.

Sandra Harwood, IDWeek conference secretariat, who proposed the idea for the first Chasing the Sun session last year, said in an interview that the updates will highlight particular COVID challenges experienced in various countries.

For example, leaders of India’s session will address why a potentially fatal fungal disease struck many COVID-19 patients in that country. Japan’s update will include how Olympic organizers planned for and dealt with the virus’s threat in Tokyo.

Ms. Harwood said that all the COVID sessions in Chasing the Sun and throughout the program will be free to clinicians inside and outside the conference, thanks to a grant from the CDC.

An address by CDC Director Rochelle Walensky, MD, MPH, on Sept. 30 will wrap up Chasing the Sun and launch the main IDWeek program.

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

Two of the three late-breaking abstract sessions coming up this week at IDWeek 2021, an annual scientific meeting on infectious diseases, are filled with the most recent evidence on COVID-19 prevention and treatment.

Adarsh Bhimraj, MD, a vice chair of the conference, said in an interview that attendees will leave the virtual conference with an up-to-date view of what’s promising in the fight against COVID-19 globally and what questions are as yet unanswered.

Researchers will also present findings on promising new antibiotics in the pipeline, stewardship efforts, health disparities, telemedicine advances, and emerging pathogens, but at least a quarter of the program is devoted to COVID-19.

“It’s hard to ignore the elephant in the room,” Dr. Bhimraj said.

Vaccine distribution will be among the hot topics at the global conference, he said, in light of the recent decisions by the Food and Drug Administration and the Centers for Disease Control and Prevention to reserve boosters for those at greatest risk.

Although the United States and other high-resource countries are deciding who should get boosters, only 10% of the developing world has received even a single dose, he noted.

The conference will also present a worldwide view of scientific collaboration to address the COVID pandemic and pandemics yet to come, Dr. Bhimraj said.

He highlighted a talk on Oct. 2, to be delivered by South African human rights attorney and social justice activist Fatima Hassan, called “Global Vaccines and Preventive Care Inequities: Implications and Solutions Beyond the Pandemic.”

The session looks ahead to building systems to share resources and knowledge to end deadly outbreaks with an equitable approach.

“We live in a global village,” Dr. Bhimraj said. “It isn’t just the right thing to do, it’s the pragmatic thing to do.”
 

Controversies in non-COVID diseases

Controversies and new treatments are plentiful in other diseases as well.

• At an HIV session, arguments will be presented regarding the sustainability and practicalities of telemedicine in HIV. Speakers will argue for and against telemedicine as a permanent practice changer for the field.
• In a session on Oct. 1, panelists will discuss pros and cons of information published in preprints versus peer-reviewed journals and how to assess when research findings should lead to practice change.
• Also on Oct. 1, panelists in a symposium will discuss advantages and disadvantages of antifungal treatments for children who have received solid organ transplants.
• Antimicrobial stewardship continues to be a primary topic at IDWeek, this year with additional pandemic challenges. Sessions will address trends in use and diagnostic advances to help in prescribing.
• The pipeline for new antibiotics continues to face barriers regarding production and development. No new classes of antibiotics have been discovered since the 1980s. Pew has that there are too few drugs in development to meet current and anticipated need.
• This year’s program offers a symposium on private-public partnerships to help jump-start development.
• One of the most popular sessions returning this year is “Clinical Trials That Will Change Your Practice,” Dr. Bhimraj said. This year, that session will be reserved for non-COVID infectious disease research. Presenters will summarize the findings of top work published in the past year.

Around-the-world COVID view

Again this year, global experts will present a round-the-clock session called “Chasing the Sun” the day before the main sessions. It will include updates on COVID throughout the world. Barney Graham, MD, PhD, deputy director of the National Institutes of Health’s Vaccine Research Center, will kick off the program with an address on the future of vaccinology. This will be followed by updates on the state of the disease in Central and South America, Japan, Asia Pacific, India, and Africa.

Sandra Harwood, IDWeek conference secretariat, who proposed the idea for the first Chasing the Sun session last year, said in an interview that the updates will highlight particular COVID challenges experienced in various countries.

For example, leaders of India’s session will address why a potentially fatal fungal disease struck many COVID-19 patients in that country. Japan’s update will include how Olympic organizers planned for and dealt with the virus’s threat in Tokyo.

Ms. Harwood said that all the COVID sessions in Chasing the Sun and throughout the program will be free to clinicians inside and outside the conference, thanks to a grant from the CDC.

An address by CDC Director Rochelle Walensky, MD, MPH, on Sept. 30 will wrap up Chasing the Sun and launch the main IDWeek program.

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

A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly, compared with placebo.

Findings were published in the New England Journal of Medicine. 

COVID-related hospitalization or death from any cause occurred in 18 of 1,355 patients (1.3%) in the group getting 2,400 mg infusions of the study drug, compared with 62 (4.6%) of 1,341 in the matching placebo group, indicating a relative risk reduction of 71.3%; P < .001.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Fla., said in an interview that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes, or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”
 

Researchers seek lowest doses

This trial found that the effect was similar when researchers cut the doses in half. These outcomes occurred in 7 of 736 (1%) of patients given 1,200 mg of REGEN-COV and in 24 (3.2%) of 748 in the matching placebo group (relative risk reduction, 70.4%; P = .002).

Symptoms were resolved on average 4 days earlier with each REGEN-COV dose than with placebo (10 days vs. 14 days; P < .001 for both comparisons).

Dr. Weinreich said in an interview that trials will continue to find the lowest effective doses that can stand up to all evolving variants.

“This is one of those settings where you don’t want to underdose. You’ve got one shot at this,” he said. “We’d love to do lower doses. It would be more convenient and we could treat more patients, but if it generates more clinical failures or doesn’t work with certain variants, then you’ve done a huge disservice to the world.”

Also new in this study is that researchers tested not only seronegative patients, but patients at high risk regardless of blood antibody status, he said.

“It’s the first suggestion of data that if you’re breaking through a vaccine and you’re at high risk, the use of the cocktail is something to strongly consider because treatment early is better than treatment later,” Dr. Weinreich said.

In addition to efficacy, the phase 3 trial demonstrated the cocktail had a good safety profile. Serious adverse events occurred more often in the placebo group (4%) than in the 1,200-mg group (1.1%) and the 2,400-mg group (1.3%). Infusion reactions (grade 2 or higher) occurred in less than 0.3% of patients in all groups. 

William Fales, MD, state medical director for the Michigan Department of Health and Human Services, said the results confirm the promise of REGEN-COV for reducing hospitalizations and death in a peer-reviewed publication.
 

COVID-19 a moving target

However, Dr. Fales noted that COVID-19 is a moving target with emerging variants. The criteria for populations at high risk have also broadened since the start of the study, he said.

“A great example is pregnancy is now included as high risk, and that would have likely been a specific contraindication of patients in this clinical trial,” he said.

Dr. Fales said Michigan has been using both REGEN-COV and the Eli Lilly combination of bamlanivimab and etesevimab, which also has an emergency use authorization (EUA) from the Food and Drug Administration, with positive results.

REGEN-COV has an EUA to treat people who are at high risk of serious consequences from COVID-19, including those who are already infected (nonhospitalized) or those in certain postexposure prophylaxis settings.

“We’re seeing very low hospitalization rates and few deaths in a state that is predominately Delta,” Dr. Fales said. “So, this makes us feel that we’re doing the right thing and supports the current efforts around the country to make monoclonal antibody therapy available to high-risk patients.”  

Dr. Joshi noted that trial results have been emerging from other monoclonal antibody cocktails with different COVID-19 patient groups.

However, he said in an interview, “how much more effective they would be than this is something we’d have to look at, as 71% effectiveness in keeping people out of the hospital is pretty good for any treatment.”

“These are great numbers, but vaccination itself keeps you from getting the disease in the first place and not just for a short time period. This treatment is just that – a treatment. It gets you through that episode but it doesn’t mean you won’t get sick again. You don’t develop an immune response as you do with the vaccine,” he said.

Dr. Weinreich agreed: “This is not a substitute for a vaccine except for the small group who get the vaccine and their bodies can’t respond to it because they’re significantly immunocompromised.”

The results from this paper “are one piece of a large, multistudy, phase 3 program that basically spans from prophylaxis all the way to hospitalization and pretty much the gamut – all of them – have worked. All of these studies have shown dramatic improvement in whatever the definitive regulatory endpoint is,” Dr. Weinreich said.

He said discussions are ongoing for full regulatory approval in the United States and for expanding the EUA for other populations, including pre-exposure prophylaxis, “which the [United Kingdom’s] authority has already granted us but the FDA has not.”

The study is funded by Regeneron and the Department of Health & Human Services. Dr. Weinreich is a vice president of Regeneron. Dr. Joshi reported no relevant financial relationships. Dr. Fales holds stock in Eli Lilly.

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

A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly, compared with placebo.

Findings were published in the New England Journal of Medicine. 

COVID-related hospitalization or death from any cause occurred in 18 of 1,355 patients (1.3%) in the group getting 2,400 mg infusions of the study drug, compared with 62 (4.6%) of 1,341 in the matching placebo group, indicating a relative risk reduction of 71.3%; P < .001.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Fla., said in an interview that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes, or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”
 

Researchers seek lowest doses

This trial found that the effect was similar when researchers cut the doses in half. These outcomes occurred in 7 of 736 (1%) of patients given 1,200 mg of REGEN-COV and in 24 (3.2%) of 748 in the matching placebo group (relative risk reduction, 70.4%; P = .002).

Symptoms were resolved on average 4 days earlier with each REGEN-COV dose than with placebo (10 days vs. 14 days; P < .001 for both comparisons).

Dr. Weinreich said in an interview that trials will continue to find the lowest effective doses that can stand up to all evolving variants.

“This is one of those settings where you don’t want to underdose. You’ve got one shot at this,” he said. “We’d love to do lower doses. It would be more convenient and we could treat more patients, but if it generates more clinical failures or doesn’t work with certain variants, then you’ve done a huge disservice to the world.”

Also new in this study is that researchers tested not only seronegative patients, but patients at high risk regardless of blood antibody status, he said.

“It’s the first suggestion of data that if you’re breaking through a vaccine and you’re at high risk, the use of the cocktail is something to strongly consider because treatment early is better than treatment later,” Dr. Weinreich said.

In addition to efficacy, the phase 3 trial demonstrated the cocktail had a good safety profile. Serious adverse events occurred more often in the placebo group (4%) than in the 1,200-mg group (1.1%) and the 2,400-mg group (1.3%). Infusion reactions (grade 2 or higher) occurred in less than 0.3% of patients in all groups. 

William Fales, MD, state medical director for the Michigan Department of Health and Human Services, said the results confirm the promise of REGEN-COV for reducing hospitalizations and death in a peer-reviewed publication.
 

COVID-19 a moving target

However, Dr. Fales noted that COVID-19 is a moving target with emerging variants. The criteria for populations at high risk have also broadened since the start of the study, he said.

“A great example is pregnancy is now included as high risk, and that would have likely been a specific contraindication of patients in this clinical trial,” he said.

Dr. Fales said Michigan has been using both REGEN-COV and the Eli Lilly combination of bamlanivimab and etesevimab, which also has an emergency use authorization (EUA) from the Food and Drug Administration, with positive results.

REGEN-COV has an EUA to treat people who are at high risk of serious consequences from COVID-19, including those who are already infected (nonhospitalized) or those in certain postexposure prophylaxis settings.

“We’re seeing very low hospitalization rates and few deaths in a state that is predominately Delta,” Dr. Fales said. “So, this makes us feel that we’re doing the right thing and supports the current efforts around the country to make monoclonal antibody therapy available to high-risk patients.”  

Dr. Joshi noted that trial results have been emerging from other monoclonal antibody cocktails with different COVID-19 patient groups.

However, he said in an interview, “how much more effective they would be than this is something we’d have to look at, as 71% effectiveness in keeping people out of the hospital is pretty good for any treatment.”

“These are great numbers, but vaccination itself keeps you from getting the disease in the first place and not just for a short time period. This treatment is just that – a treatment. It gets you through that episode but it doesn’t mean you won’t get sick again. You don’t develop an immune response as you do with the vaccine,” he said.

Dr. Weinreich agreed: “This is not a substitute for a vaccine except for the small group who get the vaccine and their bodies can’t respond to it because they’re significantly immunocompromised.”

The results from this paper “are one piece of a large, multistudy, phase 3 program that basically spans from prophylaxis all the way to hospitalization and pretty much the gamut – all of them – have worked. All of these studies have shown dramatic improvement in whatever the definitive regulatory endpoint is,” Dr. Weinreich said.

He said discussions are ongoing for full regulatory approval in the United States and for expanding the EUA for other populations, including pre-exposure prophylaxis, “which the [United Kingdom’s] authority has already granted us but the FDA has not.”

The study is funded by Regeneron and the Department of Health & Human Services. Dr. Weinreich is a vice president of Regeneron. Dr. Joshi reported no relevant financial relationships. Dr. Fales holds stock in Eli Lilly.

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

A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly, compared with placebo.

Findings were published in the New England Journal of Medicine. 

COVID-related hospitalization or death from any cause occurred in 18 of 1,355 patients (1.3%) in the group getting 2,400 mg infusions of the study drug, compared with 62 (4.6%) of 1,341 in the matching placebo group, indicating a relative risk reduction of 71.3%; P < .001.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Fla., said in an interview that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes, or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”
 

Researchers seek lowest doses

This trial found that the effect was similar when researchers cut the doses in half. These outcomes occurred in 7 of 736 (1%) of patients given 1,200 mg of REGEN-COV and in 24 (3.2%) of 748 in the matching placebo group (relative risk reduction, 70.4%; P = .002).

Symptoms were resolved on average 4 days earlier with each REGEN-COV dose than with placebo (10 days vs. 14 days; P < .001 for both comparisons).

Dr. Weinreich said in an interview that trials will continue to find the lowest effective doses that can stand up to all evolving variants.

“This is one of those settings where you don’t want to underdose. You’ve got one shot at this,” he said. “We’d love to do lower doses. It would be more convenient and we could treat more patients, but if it generates more clinical failures or doesn’t work with certain variants, then you’ve done a huge disservice to the world.”

Also new in this study is that researchers tested not only seronegative patients, but patients at high risk regardless of blood antibody status, he said.

“It’s the first suggestion of data that if you’re breaking through a vaccine and you’re at high risk, the use of the cocktail is something to strongly consider because treatment early is better than treatment later,” Dr. Weinreich said.

In addition to efficacy, the phase 3 trial demonstrated the cocktail had a good safety profile. Serious adverse events occurred more often in the placebo group (4%) than in the 1,200-mg group (1.1%) and the 2,400-mg group (1.3%). Infusion reactions (grade 2 or higher) occurred in less than 0.3% of patients in all groups. 

William Fales, MD, state medical director for the Michigan Department of Health and Human Services, said the results confirm the promise of REGEN-COV for reducing hospitalizations and death in a peer-reviewed publication.
 

COVID-19 a moving target

However, Dr. Fales noted that COVID-19 is a moving target with emerging variants. The criteria for populations at high risk have also broadened since the start of the study, he said.

“A great example is pregnancy is now included as high risk, and that would have likely been a specific contraindication of patients in this clinical trial,” he said.

Dr. Fales said Michigan has been using both REGEN-COV and the Eli Lilly combination of bamlanivimab and etesevimab, which also has an emergency use authorization (EUA) from the Food and Drug Administration, with positive results.

REGEN-COV has an EUA to treat people who are at high risk of serious consequences from COVID-19, including those who are already infected (nonhospitalized) or those in certain postexposure prophylaxis settings.

“We’re seeing very low hospitalization rates and few deaths in a state that is predominately Delta,” Dr. Fales said. “So, this makes us feel that we’re doing the right thing and supports the current efforts around the country to make monoclonal antibody therapy available to high-risk patients.”  

Dr. Joshi noted that trial results have been emerging from other monoclonal antibody cocktails with different COVID-19 patient groups.

However, he said in an interview, “how much more effective they would be than this is something we’d have to look at, as 71% effectiveness in keeping people out of the hospital is pretty good for any treatment.”

“These are great numbers, but vaccination itself keeps you from getting the disease in the first place and not just for a short time period. This treatment is just that – a treatment. It gets you through that episode but it doesn’t mean you won’t get sick again. You don’t develop an immune response as you do with the vaccine,” he said.

Dr. Weinreich agreed: “This is not a substitute for a vaccine except for the small group who get the vaccine and their bodies can’t respond to it because they’re significantly immunocompromised.”

The results from this paper “are one piece of a large, multistudy, phase 3 program that basically spans from prophylaxis all the way to hospitalization and pretty much the gamut – all of them – have worked. All of these studies have shown dramatic improvement in whatever the definitive regulatory endpoint is,” Dr. Weinreich said.

He said discussions are ongoing for full regulatory approval in the United States and for expanding the EUA for other populations, including pre-exposure prophylaxis, “which the [United Kingdom’s] authority has already granted us but the FDA has not.”

The study is funded by Regeneron and the Department of Health & Human Services. Dr. Weinreich is a vice president of Regeneron. Dr. Joshi reported no relevant financial relationships. Dr. Fales holds stock in Eli Lilly.

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

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

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

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

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

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

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