User login
NYC switching children’s COVID vaccine sites to monkeypox
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
Seniors intend to receive variant-specific COVID booster in coming months
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
U.S. tops 10,000 confirmed monkeypox cases: CDC
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
In RA, tofacitinib shows higher infection rate than TNF inhibitors
Patients with rheumatoid arthritis treated with tofacitinib (Xeljanz) are more likely to develop infections than are those who take a tumor necrosis factor inhibitor (TNFi), results of an industry-sponsored randomized controlled trial suggest.
The Janus kinase (JAK) inhibitor tofacitinib and TNFi biologics are common RA treatments that, along with factors including age, disease activity, and comorbidities, can put patients with RA at increased risk for infections.
“In this secondary analysis of the ORAL Surveillance trial, infections were increased with tofacitinib, compared with TNFi,” study coauthor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, both in Boston, explained in an interview.
As reported in Annals of the Rheumatic Diseases, Dr. Bhatt and colleagues performed a subanalysis of the final dataset from the phase 3b/4 open-label safety trial of tofacitinib in RA conducted between March 2014 and July 2020, in 345 study locations worldwide.
Study participants were 50 years of age or older with moderate to severe RA who were taking methotrexate but having inadequate symptom control. They had at least one cardiovascular risk factor such as being a current smoker or having hypertension, past heart attack, family history of coronary heart disease, high cholesterol, diabetes mellitus, or extra-articular RA. Patients with current or recent infection, clinically significant laboratory abnormalities, or pregnancy, were excluded from the study.
In the study, 1,455 participants received oral tofacitinib 5 mg twice per day; 1,456 received oral tofacitinib 10 mg twice per day; and 1,451 were treated with subcutaneous TNFi (40 mg subcutaneous adalimumab [Humira] injection every 2 weeks in the United States, Puerto Rico, and Canada; and 50 mg subcutaneous etanercept [Enbrel] injection every week in all other countries. Participants continued their prestudy stable dose of methotrexate if clinically indicated.
The researchers calculated incidence rates and hazard ratios for infections, overall and by age (50-64 years, compared with 65 years and older). They calculated probabilities of infection using Kaplan-Meier estimates and identified infection risk factors through Cox modeling.
They found higher infection rates, serious infection events (SIEs), and nonserious infections (NSIs) with tofacitinib than with TNFi, including:
- Patients taking tofacitinib 5 mg (HR, 1.17; 95% confidence interval, 0.92-1.50) and 10 mg (HR, 1.48; 95% CI, 1.17-1.87) were at greater risk for SIEs.
- Patients older than 65 who were taking tofacitinib 10 mg had increased IRs and HRs for all infections and for SIEs, compared with those aged 50-64.
- The probability of a SIE rose from month 18 onward in participants taking tofacitinib 5 mg, as well as before month 6 in those taking tofacitinib 10 mg.
- In both tofacitinib groups, the probability of NSI increased before month 6.
The most common risk factors for SIEs were higher age, baseline opioid use, history of chronic lung disease, and time-dependent oral corticosteroid use. Risk factors for NSIs were female sex, history of chronic lung disease or infection, history of smoking, as well as time-dependent higher Disease Activity Score in 28 joints and C-reactive protein score.
‘Best information to date’
Michael George, MD, MSCE, assistant professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia, welcomed the study’s results.
“This study provides the best information to date on the risk of infection with the JAK inhibitor tofacitinib, compared to a TNF inhibitor,” Dr. George, who was not involved in the study, said in an interview. “It is rare to have such a large randomized trial with an active comparator focused on safety. This is a major strength.
“Being able to quantify the amount of increased risk will help with shared decision-making when counseling patients,” he added.
Dr. George said that, while the small overall risk may not be clinically meaningful for younger, healthier patients, trying biologics such as TNFi before tofacitinib may be optimal for high-risk patients who are older or have comorbidities.
Dr. Bhatt agreed.
“In deciding on appropriate therapies for RA (or other conditions where tofacitinib is used), it is important for the prescribing physician to explain the risks to the patient and weigh them against the potential benefits,” he advised.
Dr. Bhatt noted that increased infection is not the first risk that’s been linked with tofacitinib.
“ORAL Surveillance was designed primarily to assess cardiovascular safety and showed higher rates of cardiovascular events such as myocardial infarction and pulmonary embolism, as well as cancer, with tofacitinib,” he explained.
He recommended further related research.
“Randomized trials are needed to determine the best ways to treat conditions such as RA while trying to minimize cardiovascular, cancer, and infectious risks,” he said.
The study was sponsored by Pfizer. All authors reported financial involvements with Pfizer; most have financial involvements with other pharmaceutical companies as well; four authors are employees of Pfizer and three are also stockholders in the company. Dr. George reported involvements with the pharmaceutical industry.
Patients with rheumatoid arthritis treated with tofacitinib (Xeljanz) are more likely to develop infections than are those who take a tumor necrosis factor inhibitor (TNFi), results of an industry-sponsored randomized controlled trial suggest.
The Janus kinase (JAK) inhibitor tofacitinib and TNFi biologics are common RA treatments that, along with factors including age, disease activity, and comorbidities, can put patients with RA at increased risk for infections.
“In this secondary analysis of the ORAL Surveillance trial, infections were increased with tofacitinib, compared with TNFi,” study coauthor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, both in Boston, explained in an interview.
As reported in Annals of the Rheumatic Diseases, Dr. Bhatt and colleagues performed a subanalysis of the final dataset from the phase 3b/4 open-label safety trial of tofacitinib in RA conducted between March 2014 and July 2020, in 345 study locations worldwide.
Study participants were 50 years of age or older with moderate to severe RA who were taking methotrexate but having inadequate symptom control. They had at least one cardiovascular risk factor such as being a current smoker or having hypertension, past heart attack, family history of coronary heart disease, high cholesterol, diabetes mellitus, or extra-articular RA. Patients with current or recent infection, clinically significant laboratory abnormalities, or pregnancy, were excluded from the study.
In the study, 1,455 participants received oral tofacitinib 5 mg twice per day; 1,456 received oral tofacitinib 10 mg twice per day; and 1,451 were treated with subcutaneous TNFi (40 mg subcutaneous adalimumab [Humira] injection every 2 weeks in the United States, Puerto Rico, and Canada; and 50 mg subcutaneous etanercept [Enbrel] injection every week in all other countries. Participants continued their prestudy stable dose of methotrexate if clinically indicated.
The researchers calculated incidence rates and hazard ratios for infections, overall and by age (50-64 years, compared with 65 years and older). They calculated probabilities of infection using Kaplan-Meier estimates and identified infection risk factors through Cox modeling.
They found higher infection rates, serious infection events (SIEs), and nonserious infections (NSIs) with tofacitinib than with TNFi, including:
- Patients taking tofacitinib 5 mg (HR, 1.17; 95% confidence interval, 0.92-1.50) and 10 mg (HR, 1.48; 95% CI, 1.17-1.87) were at greater risk for SIEs.
- Patients older than 65 who were taking tofacitinib 10 mg had increased IRs and HRs for all infections and for SIEs, compared with those aged 50-64.
- The probability of a SIE rose from month 18 onward in participants taking tofacitinib 5 mg, as well as before month 6 in those taking tofacitinib 10 mg.
- In both tofacitinib groups, the probability of NSI increased before month 6.
The most common risk factors for SIEs were higher age, baseline opioid use, history of chronic lung disease, and time-dependent oral corticosteroid use. Risk factors for NSIs were female sex, history of chronic lung disease or infection, history of smoking, as well as time-dependent higher Disease Activity Score in 28 joints and C-reactive protein score.
‘Best information to date’
Michael George, MD, MSCE, assistant professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia, welcomed the study’s results.
“This study provides the best information to date on the risk of infection with the JAK inhibitor tofacitinib, compared to a TNF inhibitor,” Dr. George, who was not involved in the study, said in an interview. “It is rare to have such a large randomized trial with an active comparator focused on safety. This is a major strength.
“Being able to quantify the amount of increased risk will help with shared decision-making when counseling patients,” he added.
Dr. George said that, while the small overall risk may not be clinically meaningful for younger, healthier patients, trying biologics such as TNFi before tofacitinib may be optimal for high-risk patients who are older or have comorbidities.
Dr. Bhatt agreed.
“In deciding on appropriate therapies for RA (or other conditions where tofacitinib is used), it is important for the prescribing physician to explain the risks to the patient and weigh them against the potential benefits,” he advised.
Dr. Bhatt noted that increased infection is not the first risk that’s been linked with tofacitinib.
“ORAL Surveillance was designed primarily to assess cardiovascular safety and showed higher rates of cardiovascular events such as myocardial infarction and pulmonary embolism, as well as cancer, with tofacitinib,” he explained.
He recommended further related research.
“Randomized trials are needed to determine the best ways to treat conditions such as RA while trying to minimize cardiovascular, cancer, and infectious risks,” he said.
The study was sponsored by Pfizer. All authors reported financial involvements with Pfizer; most have financial involvements with other pharmaceutical companies as well; four authors are employees of Pfizer and three are also stockholders in the company. Dr. George reported involvements with the pharmaceutical industry.
Patients with rheumatoid arthritis treated with tofacitinib (Xeljanz) are more likely to develop infections than are those who take a tumor necrosis factor inhibitor (TNFi), results of an industry-sponsored randomized controlled trial suggest.
The Janus kinase (JAK) inhibitor tofacitinib and TNFi biologics are common RA treatments that, along with factors including age, disease activity, and comorbidities, can put patients with RA at increased risk for infections.
“In this secondary analysis of the ORAL Surveillance trial, infections were increased with tofacitinib, compared with TNFi,” study coauthor Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, both in Boston, explained in an interview.
As reported in Annals of the Rheumatic Diseases, Dr. Bhatt and colleagues performed a subanalysis of the final dataset from the phase 3b/4 open-label safety trial of tofacitinib in RA conducted between March 2014 and July 2020, in 345 study locations worldwide.
Study participants were 50 years of age or older with moderate to severe RA who were taking methotrexate but having inadequate symptom control. They had at least one cardiovascular risk factor such as being a current smoker or having hypertension, past heart attack, family history of coronary heart disease, high cholesterol, diabetes mellitus, or extra-articular RA. Patients with current or recent infection, clinically significant laboratory abnormalities, or pregnancy, were excluded from the study.
In the study, 1,455 participants received oral tofacitinib 5 mg twice per day; 1,456 received oral tofacitinib 10 mg twice per day; and 1,451 were treated with subcutaneous TNFi (40 mg subcutaneous adalimumab [Humira] injection every 2 weeks in the United States, Puerto Rico, and Canada; and 50 mg subcutaneous etanercept [Enbrel] injection every week in all other countries. Participants continued their prestudy stable dose of methotrexate if clinically indicated.
The researchers calculated incidence rates and hazard ratios for infections, overall and by age (50-64 years, compared with 65 years and older). They calculated probabilities of infection using Kaplan-Meier estimates and identified infection risk factors through Cox modeling.
They found higher infection rates, serious infection events (SIEs), and nonserious infections (NSIs) with tofacitinib than with TNFi, including:
- Patients taking tofacitinib 5 mg (HR, 1.17; 95% confidence interval, 0.92-1.50) and 10 mg (HR, 1.48; 95% CI, 1.17-1.87) were at greater risk for SIEs.
- Patients older than 65 who were taking tofacitinib 10 mg had increased IRs and HRs for all infections and for SIEs, compared with those aged 50-64.
- The probability of a SIE rose from month 18 onward in participants taking tofacitinib 5 mg, as well as before month 6 in those taking tofacitinib 10 mg.
- In both tofacitinib groups, the probability of NSI increased before month 6.
The most common risk factors for SIEs were higher age, baseline opioid use, history of chronic lung disease, and time-dependent oral corticosteroid use. Risk factors for NSIs were female sex, history of chronic lung disease or infection, history of smoking, as well as time-dependent higher Disease Activity Score in 28 joints and C-reactive protein score.
‘Best information to date’
Michael George, MD, MSCE, assistant professor of medicine and epidemiology at the University of Pennsylvania, Philadelphia, welcomed the study’s results.
“This study provides the best information to date on the risk of infection with the JAK inhibitor tofacitinib, compared to a TNF inhibitor,” Dr. George, who was not involved in the study, said in an interview. “It is rare to have such a large randomized trial with an active comparator focused on safety. This is a major strength.
“Being able to quantify the amount of increased risk will help with shared decision-making when counseling patients,” he added.
Dr. George said that, while the small overall risk may not be clinically meaningful for younger, healthier patients, trying biologics such as TNFi before tofacitinib may be optimal for high-risk patients who are older or have comorbidities.
Dr. Bhatt agreed.
“In deciding on appropriate therapies for RA (or other conditions where tofacitinib is used), it is important for the prescribing physician to explain the risks to the patient and weigh them against the potential benefits,” he advised.
Dr. Bhatt noted that increased infection is not the first risk that’s been linked with tofacitinib.
“ORAL Surveillance was designed primarily to assess cardiovascular safety and showed higher rates of cardiovascular events such as myocardial infarction and pulmonary embolism, as well as cancer, with tofacitinib,” he explained.
He recommended further related research.
“Randomized trials are needed to determine the best ways to treat conditions such as RA while trying to minimize cardiovascular, cancer, and infectious risks,” he said.
The study was sponsored by Pfizer. All authors reported financial involvements with Pfizer; most have financial involvements with other pharmaceutical companies as well; four authors are employees of Pfizer and three are also stockholders in the company. Dr. George reported involvements with the pharmaceutical industry.
FROM ANNALS OF THE RHEUMATIC DISEASES
FDA authorizes intradermal use of Jynneos vaccine for monkeypox
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
Tobramycin tames infection in bronchiectasis
Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.
Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.
In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.
The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.
Overall, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.
In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.
Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.
The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.
However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.
The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.
Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.
In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.
The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.
Overall, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.
In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.
Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.
The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.
However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.
The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nebulized tobramycin significantly reduced the density of Pseudomonas aeruginosa in sputum and improved quality of life for adults with bronchiectasis in a study with more than 300 individuals.
Chronic P. aeruginosa infection remains a challenge for bronchiectasis patients, and treatment options are limited, wrote Wei-jie Guan, MD, of the First Affiliated Hospital of Guangzhou Medical University, Guangdong, China, and colleagues. Tobramycin has demonstrated antipseudomonal effects, but previous studies have been small, results have been inconclusive, and there are safety concerns with the currently approved method of intravenous injection.
In a study published in the journal Chest, the researchers randomly assigned 167 patients to receive nebulized tobramycin inhalation solution (TIS) and 172 patients to receive placebo. Patients in the active-treatment group received 300 mg/5 mL of TIS twice daily in two cycles of 28 days on- and off-treatment alternating periods. The primary endpoints were changes in P. aeruginosa density from baseline and scores on the Quality of Life–Bronchiectasis questionnaire at day 29. Follow-up data were collected every 4 weeks for 16 weeks. Secondary endpoints included rate of negative P. aeruginosa culture at day 29; change in P. aeruginosa density from baseline; quality of life at day 85; and 24-hour sputum volume and purulence at day 29, 57, and 85.
The study population included adults aged 18-75 years with symptomatic bronchiectasis. The participants’ conditions had been clinically stable for 4 weeks. Sputum cultures tested positive for P. aeruginosa at two consecutive screening visits prior to randomization. The study was conducted at 33 sites within mainland China.
Overall, with an adjusted mean difference of 1.74 Log10 colony-forming units/g (P < .001). TIS patients also showed significantly greater improvement in Quality of Life–Bronchiectasis respiratory symptom scores, with an adjusted mean difference of 7.91 (P < .001) at day 29.
In addition, more TIS patients became culture negative for P. aeruginosa by day 29, compared with placebo patients (29.3% vs. 10.6%), and 24-hour sputum volume and sputum purulence scores were significantly lower for TIS patients at day 29, day 57, and day 85, compared with placebo patients.
Adverse events were similar and occurred in 81.5% of TIS patients and 81.6% of placebo patients. The most common were hemoptysis, chest discomfort, and acute upper respiratory tract infections. A total of 10 patients in the TIS group experienced transient wheezing that resolved within 30 minutes. A total of 11 TIS patients and 5 placebo patients experienced an adverse event that caused them to discontinue participation in the study. These events included blurred vision and dizziness, which occurred in two TIS patients and was deemed related to the study drug. One TIS patient died as a result of acute myocardial infarction, but this was deemed to be unrelated to the study drug.
The findings were limited by several factors, including the short duration of treatment and relatively young population, which might affect generalizability, the researchers noted. Other limitations include a lack of data on the effects of TIS on microorganisms other than P. aeruginosa, as well as limited outpatient visits, owing to COVID-19 restrictions.
However, the results confirm the ability of TIS nebulization to reduce P. aeruginosa and improve quality of life for adult patients with bronchiectasis, the authors concluded.
The study was funded by grants to multiple researchers from the National Science and Technology Major Project of the Ministry of Science and Technology of China and other government sources. The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CHEST
In one state, pandemic tamped down lice and scabies cases
.
When COVID-19 was declared a public health emergency by the World Health Organization in March 2020, many countries including the United States enacted lockdown and isolation measures to help contain the spread of the disease. Since scabies and lice are both spread by direct contact, “we hypothesized that the nationwide lockdown would influence the transmission of these two conditions among individuals,” wrote Marianne Bonanno, MD, of the University of North Carolina, Chapel Hill, and colleagues.
“The pandemic created a unique opportunity for real-life observations following physical distancing measures being put in place,” coauthor Christopher Sayed, MD, associate professor of dermatology at UNC, said in an interview. “It makes intuitive sense that since lice and scabies spread by cost physical contact that rates would decrease with school closures and other physical distancing measures. Reports from other countries in which extended families more often live together and were forced to spend more time in close quarters saw increased rates so it was interesting to see this contrast,” he noted.
In the study, the researchers reviewed data from 1,858 cases of adult scabies, 893 cases of pediatric scabies, and 804 cases of pediatric lice reported in North Carolina between March 2017 and February 2021. They compared monthly cases of scabies and lice, and prescriptions during the period before the pandemic (March 2017 to February 2020), and during the pandemic (March 2020 to February 2021).
Pediatric lice cases decreased by 60.6% over the study period (P < .001). Significant decreases also occurred in adult scabies (31.1%, P < .001) and pediatric scabies (39%, P < .01).
The number of prescriptions for lice and scabies also decreased significantly (P < .01) during the study period, although these numbers differed from the actual cases. Prescriptions decreased by 41.4%, 29.9%, and 69.3% for pediatric scabies, adult scabies, and pediatric lice, respectively.
Both pediatric scabies and pediatric lice showed a greater drop in prescriptions than in cases, while the drop in prescriptions for adult scabies was slightly less than the drop in cases.
The difference in the decreased numbers between cases and prescriptions may stem from the decrease in close contacts during the pandemic, which decreased the need for multiple prescriptions, but other potential explanations could be examined in future studies, the researchers wrote in their discussion.
The study findings were limited by several factors including the cross-sectional design and potential underdiagnosis and underreporting, as well as the focus only on a population in a single state, which may limit generalizability, the researchers noted.
However, the results offer preliminary insights on the impact of COVID-19 restrictions on scabies and lice, and suggest the potential value of physical distancing to reduce transmission of both conditions, especially in settings such as schools and prisons, to help contain future outbreaks, they concluded.
The study findings reinforce physical contact as the likely route of disease transmission, for lice and scabies, Dr. Sayed said in the interview. “It’s possible distancing measures on a small scale could be considered for outbreaks in institutional settings, though the risks of these infestations are much lower than with COVID-19,” he said. “It will be interesting to observe trends as physical distancing measures end to see if cases rebound in the next few years,” he added.
Drop in cases likely temporary
“Examining the epidemiology of different infectious diseases over time is an interesting and important area of study,” said Sheilagh Maguiness, MD, associate professor of dermatology and pediatrics at the University of Minnesota, Minneapolis, who was asked to comment on the results.
“The pandemic dramatically altered the daily lives of adults and children across the globe, and we can learn a lot from studying how social distancing and prolonged masking has made an impact on the incidence and prevalence of different infectious illnesses in the country and across the world,” she said in an interview.
Dr. Maguiness said she was not surprised by the study findings. “In fact, other countries have published similar studies documenting a reduction in both head lice and scabies infestations during the time of the pandemic,” she said. “In France, it was noted that during March to December 2020, there was a reduction in sales for topical head lice and scabies treatments of 44% and 14%, respectively. Similarly, a study from Argentina documented a decline in head lice infestations by about 25% among children,” she said.
“I personally noted a marked decrease in both of these diagnoses among children in my own clinic,” she added.
“Since both of these conditions are spread through close physical contact with others, it makes sense that there would be a steep decline in ectoparasitic infections during times of social distancing. However, anecdotally we are now diagnosing and treating these infestations again more regularly in our clinic,” said Dr. Maguiness. “As social distancing relaxes, I would expect that the incidence of both head lice and scabies will again increase.”
The study received no outside funding. The researchers and Dr. Maguiness had no financial conflicts to disclose.
.
When COVID-19 was declared a public health emergency by the World Health Organization in March 2020, many countries including the United States enacted lockdown and isolation measures to help contain the spread of the disease. Since scabies and lice are both spread by direct contact, “we hypothesized that the nationwide lockdown would influence the transmission of these two conditions among individuals,” wrote Marianne Bonanno, MD, of the University of North Carolina, Chapel Hill, and colleagues.
“The pandemic created a unique opportunity for real-life observations following physical distancing measures being put in place,” coauthor Christopher Sayed, MD, associate professor of dermatology at UNC, said in an interview. “It makes intuitive sense that since lice and scabies spread by cost physical contact that rates would decrease with school closures and other physical distancing measures. Reports from other countries in which extended families more often live together and were forced to spend more time in close quarters saw increased rates so it was interesting to see this contrast,” he noted.
In the study, the researchers reviewed data from 1,858 cases of adult scabies, 893 cases of pediatric scabies, and 804 cases of pediatric lice reported in North Carolina between March 2017 and February 2021. They compared monthly cases of scabies and lice, and prescriptions during the period before the pandemic (March 2017 to February 2020), and during the pandemic (March 2020 to February 2021).
Pediatric lice cases decreased by 60.6% over the study period (P < .001). Significant decreases also occurred in adult scabies (31.1%, P < .001) and pediatric scabies (39%, P < .01).
The number of prescriptions for lice and scabies also decreased significantly (P < .01) during the study period, although these numbers differed from the actual cases. Prescriptions decreased by 41.4%, 29.9%, and 69.3% for pediatric scabies, adult scabies, and pediatric lice, respectively.
Both pediatric scabies and pediatric lice showed a greater drop in prescriptions than in cases, while the drop in prescriptions for adult scabies was slightly less than the drop in cases.
The difference in the decreased numbers between cases and prescriptions may stem from the decrease in close contacts during the pandemic, which decreased the need for multiple prescriptions, but other potential explanations could be examined in future studies, the researchers wrote in their discussion.
The study findings were limited by several factors including the cross-sectional design and potential underdiagnosis and underreporting, as well as the focus only on a population in a single state, which may limit generalizability, the researchers noted.
However, the results offer preliminary insights on the impact of COVID-19 restrictions on scabies and lice, and suggest the potential value of physical distancing to reduce transmission of both conditions, especially in settings such as schools and prisons, to help contain future outbreaks, they concluded.
The study findings reinforce physical contact as the likely route of disease transmission, for lice and scabies, Dr. Sayed said in the interview. “It’s possible distancing measures on a small scale could be considered for outbreaks in institutional settings, though the risks of these infestations are much lower than with COVID-19,” he said. “It will be interesting to observe trends as physical distancing measures end to see if cases rebound in the next few years,” he added.
Drop in cases likely temporary
“Examining the epidemiology of different infectious diseases over time is an interesting and important area of study,” said Sheilagh Maguiness, MD, associate professor of dermatology and pediatrics at the University of Minnesota, Minneapolis, who was asked to comment on the results.
“The pandemic dramatically altered the daily lives of adults and children across the globe, and we can learn a lot from studying how social distancing and prolonged masking has made an impact on the incidence and prevalence of different infectious illnesses in the country and across the world,” she said in an interview.
Dr. Maguiness said she was not surprised by the study findings. “In fact, other countries have published similar studies documenting a reduction in both head lice and scabies infestations during the time of the pandemic,” she said. “In France, it was noted that during March to December 2020, there was a reduction in sales for topical head lice and scabies treatments of 44% and 14%, respectively. Similarly, a study from Argentina documented a decline in head lice infestations by about 25% among children,” she said.
“I personally noted a marked decrease in both of these diagnoses among children in my own clinic,” she added.
“Since both of these conditions are spread through close physical contact with others, it makes sense that there would be a steep decline in ectoparasitic infections during times of social distancing. However, anecdotally we are now diagnosing and treating these infestations again more regularly in our clinic,” said Dr. Maguiness. “As social distancing relaxes, I would expect that the incidence of both head lice and scabies will again increase.”
The study received no outside funding. The researchers and Dr. Maguiness had no financial conflicts to disclose.
.
When COVID-19 was declared a public health emergency by the World Health Organization in March 2020, many countries including the United States enacted lockdown and isolation measures to help contain the spread of the disease. Since scabies and lice are both spread by direct contact, “we hypothesized that the nationwide lockdown would influence the transmission of these two conditions among individuals,” wrote Marianne Bonanno, MD, of the University of North Carolina, Chapel Hill, and colleagues.
“The pandemic created a unique opportunity for real-life observations following physical distancing measures being put in place,” coauthor Christopher Sayed, MD, associate professor of dermatology at UNC, said in an interview. “It makes intuitive sense that since lice and scabies spread by cost physical contact that rates would decrease with school closures and other physical distancing measures. Reports from other countries in which extended families more often live together and were forced to spend more time in close quarters saw increased rates so it was interesting to see this contrast,” he noted.
In the study, the researchers reviewed data from 1,858 cases of adult scabies, 893 cases of pediatric scabies, and 804 cases of pediatric lice reported in North Carolina between March 2017 and February 2021. They compared monthly cases of scabies and lice, and prescriptions during the period before the pandemic (March 2017 to February 2020), and during the pandemic (March 2020 to February 2021).
Pediatric lice cases decreased by 60.6% over the study period (P < .001). Significant decreases also occurred in adult scabies (31.1%, P < .001) and pediatric scabies (39%, P < .01).
The number of prescriptions for lice and scabies also decreased significantly (P < .01) during the study period, although these numbers differed from the actual cases. Prescriptions decreased by 41.4%, 29.9%, and 69.3% for pediatric scabies, adult scabies, and pediatric lice, respectively.
Both pediatric scabies and pediatric lice showed a greater drop in prescriptions than in cases, while the drop in prescriptions for adult scabies was slightly less than the drop in cases.
The difference in the decreased numbers between cases and prescriptions may stem from the decrease in close contacts during the pandemic, which decreased the need for multiple prescriptions, but other potential explanations could be examined in future studies, the researchers wrote in their discussion.
The study findings were limited by several factors including the cross-sectional design and potential underdiagnosis and underreporting, as well as the focus only on a population in a single state, which may limit generalizability, the researchers noted.
However, the results offer preliminary insights on the impact of COVID-19 restrictions on scabies and lice, and suggest the potential value of physical distancing to reduce transmission of both conditions, especially in settings such as schools and prisons, to help contain future outbreaks, they concluded.
The study findings reinforce physical contact as the likely route of disease transmission, for lice and scabies, Dr. Sayed said in the interview. “It’s possible distancing measures on a small scale could be considered for outbreaks in institutional settings, though the risks of these infestations are much lower than with COVID-19,” he said. “It will be interesting to observe trends as physical distancing measures end to see if cases rebound in the next few years,” he added.
Drop in cases likely temporary
“Examining the epidemiology of different infectious diseases over time is an interesting and important area of study,” said Sheilagh Maguiness, MD, associate professor of dermatology and pediatrics at the University of Minnesota, Minneapolis, who was asked to comment on the results.
“The pandemic dramatically altered the daily lives of adults and children across the globe, and we can learn a lot from studying how social distancing and prolonged masking has made an impact on the incidence and prevalence of different infectious illnesses in the country and across the world,” she said in an interview.
Dr. Maguiness said she was not surprised by the study findings. “In fact, other countries have published similar studies documenting a reduction in both head lice and scabies infestations during the time of the pandemic,” she said. “In France, it was noted that during March to December 2020, there was a reduction in sales for topical head lice and scabies treatments of 44% and 14%, respectively. Similarly, a study from Argentina documented a decline in head lice infestations by about 25% among children,” she said.
“I personally noted a marked decrease in both of these diagnoses among children in my own clinic,” she added.
“Since both of these conditions are spread through close physical contact with others, it makes sense that there would be a steep decline in ectoparasitic infections during times of social distancing. However, anecdotally we are now diagnosing and treating these infestations again more regularly in our clinic,” said Dr. Maguiness. “As social distancing relaxes, I would expect that the incidence of both head lice and scabies will again increase.”
The study received no outside funding. The researchers and Dr. Maguiness had no financial conflicts to disclose.
FROM PEDIATRIC DERMATOLOGY
Climate change can worsen more than half of infectious diseases
An extensive new study shows that climate change can aggravate over half of known human pathogenic diseases. This comprehensive systematic review of the literature narrowed down 3,213 cases, linking 286 infectious diseases to specific climate change hazards. Of these, 58% were worsened, and only 9 conditions showed any benefit associated with environmental change.
The study was published online in Nature Climate Change. The complete list of cases, transmission pathways, and associated papers can be explored in detail – a remarkable, interactive data visualization.
To compile the data, investigators searched 10 keywords on the Global Infectious Disease and Epidemiology Network (GIDEON) and Center for Disease Control and Prevention databases. They then filled gaps by examining alternative names of the diseases, pathogens, and hazards.
Coauthor Tristan McKenzie, PhD, a postdoctoral researcher at the University of Gothenburg, Sweden, told this news organization: “If someone is interested in a certain pathway, it’s a beautiful starting point.” Or if someone wants to “do a modeling study and they want to focus on a specific area, the specific examples in the literature are already there” in the extensive database.
An early key finding is that warming and increased precipitation broadened the range of many pathogens through expansion of their habitat. This shift brings many pathogens closer to people. Examples are viruses (dengue, Chikungunya), bacteria (Lyme), protozoans (trypanosomes), and more. Warming has affected aquatic systems (for example, Vibrio) and higher altitudes and latitudes (malaria, dengue).
Pathogenic hazards are not just moving closer to people. People are also moving closer to the pathogenic hazards, with heat waves causing people to seek refuge with water activities, for example. This increases their exposure to pathogens, such as Vibrio, hepatitis, and water-borne gastroenteritis.
Some hazards, such as warming, can even make pathogens more virulent. Heat can upregulate Vibrio’s gene expression of proteins affecting transmission, adhesion, penetration, and host injury.
Heat and rainfall can increase stagnant water, enhancing mosquitoes’ breeding and growing grounds and enabling them to transmit many more infections.
People’s capacity to respond to climate hazards can also be impaired. For example, there is a reduced concentration of nutrients in crops under high CO2 levels, which can result in malnutrition. Lower crop yields can further fuel outbreaks of measles, cholera, or Cryptosporidium. Drought also likely forces people to drink contaminated water.
Among all this bad news, the authors found a small number of cases where climate hazards reduced the risk of infection. For example, droughts reduced the breeding grounds of mosquitoes, reducing the prevalence of malaria and chikungunya. But in other cases, the density of mosquitoes increased in some pools, causing an increased local risk of infection.
Naomi Hauser, MD, MPH, assistant clinical professor at UC Davis, Sacramento, told this news organization she was particularly impressed with the data visualization. “It really emphasizes the magnitude of what we’re dealing with. It makes you feel the weight of what they’re trying to represent,” she said.
On the other hand, Dr. Hauser said she would have liked “more emphasis on how the climate hazards interact with each other. It sort of made it sound like each of these climate hazards is in a vacuum – like when there’s floods, and that’s the problem. But there are a lot of other things ... like when we have warming and surface water temperature changes, it can also change the pH of the water and the salinity of the water, and those can also impact what we see with pathogens in the water.”
Dr. McKenzie explained one limitation: The study looked only at 10 keywords. So an example of a dust storm in Africa causing an increase in Vibrio in the United States could not be identified by this approach. “This also goes back to the scale of the problem, because we have something going on in the Sahara that’s impacting the East Coast of the United States,” he said. “And finding that link is not necessarily obvious – or at least not as obvious as [if] there [were] a hurricane and a bunch of people got sick from waterborne disease. So I think that really highlights the scale of this problem.”
Instead of looking at only one individual or group of pathogens, the study provided a much broader review of infections caused by an array of climate hazards. As Dr. McKenzie said, “no one’s actually done the work previously to really just try and get a comprehensive picture of what we might be dealing with. And so that was the goal for us.” The 58% estimate of diseases worsened by climate change is conservative, and, he says, “arguably, this is an even bigger problem than what we present.”
Dr. McKenzie concluded: “If we’re looking at the spread of some more serious or rare diseases in areas, to me then the answer is ... we need to be aggressively mitigating greenhouse gas emissions. Let’s start with the source.”
Dr. McKenzie and Dr. Hauser report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An extensive new study shows that climate change can aggravate over half of known human pathogenic diseases. This comprehensive systematic review of the literature narrowed down 3,213 cases, linking 286 infectious diseases to specific climate change hazards. Of these, 58% were worsened, and only 9 conditions showed any benefit associated with environmental change.
The study was published online in Nature Climate Change. The complete list of cases, transmission pathways, and associated papers can be explored in detail – a remarkable, interactive data visualization.
To compile the data, investigators searched 10 keywords on the Global Infectious Disease and Epidemiology Network (GIDEON) and Center for Disease Control and Prevention databases. They then filled gaps by examining alternative names of the diseases, pathogens, and hazards.
Coauthor Tristan McKenzie, PhD, a postdoctoral researcher at the University of Gothenburg, Sweden, told this news organization: “If someone is interested in a certain pathway, it’s a beautiful starting point.” Or if someone wants to “do a modeling study and they want to focus on a specific area, the specific examples in the literature are already there” in the extensive database.
An early key finding is that warming and increased precipitation broadened the range of many pathogens through expansion of their habitat. This shift brings many pathogens closer to people. Examples are viruses (dengue, Chikungunya), bacteria (Lyme), protozoans (trypanosomes), and more. Warming has affected aquatic systems (for example, Vibrio) and higher altitudes and latitudes (malaria, dengue).
Pathogenic hazards are not just moving closer to people. People are also moving closer to the pathogenic hazards, with heat waves causing people to seek refuge with water activities, for example. This increases their exposure to pathogens, such as Vibrio, hepatitis, and water-borne gastroenteritis.
Some hazards, such as warming, can even make pathogens more virulent. Heat can upregulate Vibrio’s gene expression of proteins affecting transmission, adhesion, penetration, and host injury.
Heat and rainfall can increase stagnant water, enhancing mosquitoes’ breeding and growing grounds and enabling them to transmit many more infections.
People’s capacity to respond to climate hazards can also be impaired. For example, there is a reduced concentration of nutrients in crops under high CO2 levels, which can result in malnutrition. Lower crop yields can further fuel outbreaks of measles, cholera, or Cryptosporidium. Drought also likely forces people to drink contaminated water.
Among all this bad news, the authors found a small number of cases where climate hazards reduced the risk of infection. For example, droughts reduced the breeding grounds of mosquitoes, reducing the prevalence of malaria and chikungunya. But in other cases, the density of mosquitoes increased in some pools, causing an increased local risk of infection.
Naomi Hauser, MD, MPH, assistant clinical professor at UC Davis, Sacramento, told this news organization she was particularly impressed with the data visualization. “It really emphasizes the magnitude of what we’re dealing with. It makes you feel the weight of what they’re trying to represent,” she said.
On the other hand, Dr. Hauser said she would have liked “more emphasis on how the climate hazards interact with each other. It sort of made it sound like each of these climate hazards is in a vacuum – like when there’s floods, and that’s the problem. But there are a lot of other things ... like when we have warming and surface water temperature changes, it can also change the pH of the water and the salinity of the water, and those can also impact what we see with pathogens in the water.”
Dr. McKenzie explained one limitation: The study looked only at 10 keywords. So an example of a dust storm in Africa causing an increase in Vibrio in the United States could not be identified by this approach. “This also goes back to the scale of the problem, because we have something going on in the Sahara that’s impacting the East Coast of the United States,” he said. “And finding that link is not necessarily obvious – or at least not as obvious as [if] there [were] a hurricane and a bunch of people got sick from waterborne disease. So I think that really highlights the scale of this problem.”
Instead of looking at only one individual or group of pathogens, the study provided a much broader review of infections caused by an array of climate hazards. As Dr. McKenzie said, “no one’s actually done the work previously to really just try and get a comprehensive picture of what we might be dealing with. And so that was the goal for us.” The 58% estimate of diseases worsened by climate change is conservative, and, he says, “arguably, this is an even bigger problem than what we present.”
Dr. McKenzie concluded: “If we’re looking at the spread of some more serious or rare diseases in areas, to me then the answer is ... we need to be aggressively mitigating greenhouse gas emissions. Let’s start with the source.”
Dr. McKenzie and Dr. Hauser report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An extensive new study shows that climate change can aggravate over half of known human pathogenic diseases. This comprehensive systematic review of the literature narrowed down 3,213 cases, linking 286 infectious diseases to specific climate change hazards. Of these, 58% were worsened, and only 9 conditions showed any benefit associated with environmental change.
The study was published online in Nature Climate Change. The complete list of cases, transmission pathways, and associated papers can be explored in detail – a remarkable, interactive data visualization.
To compile the data, investigators searched 10 keywords on the Global Infectious Disease and Epidemiology Network (GIDEON) and Center for Disease Control and Prevention databases. They then filled gaps by examining alternative names of the diseases, pathogens, and hazards.
Coauthor Tristan McKenzie, PhD, a postdoctoral researcher at the University of Gothenburg, Sweden, told this news organization: “If someone is interested in a certain pathway, it’s a beautiful starting point.” Or if someone wants to “do a modeling study and they want to focus on a specific area, the specific examples in the literature are already there” in the extensive database.
An early key finding is that warming and increased precipitation broadened the range of many pathogens through expansion of their habitat. This shift brings many pathogens closer to people. Examples are viruses (dengue, Chikungunya), bacteria (Lyme), protozoans (trypanosomes), and more. Warming has affected aquatic systems (for example, Vibrio) and higher altitudes and latitudes (malaria, dengue).
Pathogenic hazards are not just moving closer to people. People are also moving closer to the pathogenic hazards, with heat waves causing people to seek refuge with water activities, for example. This increases their exposure to pathogens, such as Vibrio, hepatitis, and water-borne gastroenteritis.
Some hazards, such as warming, can even make pathogens more virulent. Heat can upregulate Vibrio’s gene expression of proteins affecting transmission, adhesion, penetration, and host injury.
Heat and rainfall can increase stagnant water, enhancing mosquitoes’ breeding and growing grounds and enabling them to transmit many more infections.
People’s capacity to respond to climate hazards can also be impaired. For example, there is a reduced concentration of nutrients in crops under high CO2 levels, which can result in malnutrition. Lower crop yields can further fuel outbreaks of measles, cholera, or Cryptosporidium. Drought also likely forces people to drink contaminated water.
Among all this bad news, the authors found a small number of cases where climate hazards reduced the risk of infection. For example, droughts reduced the breeding grounds of mosquitoes, reducing the prevalence of malaria and chikungunya. But in other cases, the density of mosquitoes increased in some pools, causing an increased local risk of infection.
Naomi Hauser, MD, MPH, assistant clinical professor at UC Davis, Sacramento, told this news organization she was particularly impressed with the data visualization. “It really emphasizes the magnitude of what we’re dealing with. It makes you feel the weight of what they’re trying to represent,” she said.
On the other hand, Dr. Hauser said she would have liked “more emphasis on how the climate hazards interact with each other. It sort of made it sound like each of these climate hazards is in a vacuum – like when there’s floods, and that’s the problem. But there are a lot of other things ... like when we have warming and surface water temperature changes, it can also change the pH of the water and the salinity of the water, and those can also impact what we see with pathogens in the water.”
Dr. McKenzie explained one limitation: The study looked only at 10 keywords. So an example of a dust storm in Africa causing an increase in Vibrio in the United States could not be identified by this approach. “This also goes back to the scale of the problem, because we have something going on in the Sahara that’s impacting the East Coast of the United States,” he said. “And finding that link is not necessarily obvious – or at least not as obvious as [if] there [were] a hurricane and a bunch of people got sick from waterborne disease. So I think that really highlights the scale of this problem.”
Instead of looking at only one individual or group of pathogens, the study provided a much broader review of infections caused by an array of climate hazards. As Dr. McKenzie said, “no one’s actually done the work previously to really just try and get a comprehensive picture of what we might be dealing with. And so that was the goal for us.” The 58% estimate of diseases worsened by climate change is conservative, and, he says, “arguably, this is an even bigger problem than what we present.”
Dr. McKenzie concluded: “If we’re looking at the spread of some more serious or rare diseases in areas, to me then the answer is ... we need to be aggressively mitigating greenhouse gas emissions. Let’s start with the source.”
Dr. McKenzie and Dr. Hauser report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Children and COVID: Severe illness rising as vaccination effort stalls
, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.
The deceleration in new cases, however, does not apply to emergency department visits and hospital admissions. The proportion of ED visits with diagnosed COVID rose steadily throughout June and July, as 7-day averages went from 2.6% on June 1 to 6.3% on July 31 for children aged 0-11 years, from 2.1% to 3.1% for children aged 12-15, and from 2.4% to 3.5% for 16- to 17-year-olds, according to data from the Centers for Disease Control and Prevention.
The rate of new admissions with confirmed COVID, which reached 0.46 per 100,000 population for children aged 0-17 years on July 30, has more than tripled since early April, when it had fallen to 0.13 per 100,000 in the wake of the Omicron surge, the CDC reported on its COVID Data Tracker.
A smaller but more detailed sample of children from the COVID-19–Associated Hospitalization Network (COVID-NET), which covers nearly 100 counties in 14 states, indicates that the increase in new admissions is occurring almost entirely among children aged 0-4 years, who had a rate of 5.6 per 100,000 for the week of July 17-23, compared with 0.8 per 100,000 for 5- to 11-year-olds and 1.5 per 100,000 for those aged 12-17, the CDC said.
Vaccine’s summer rollout gets lukewarm reception
As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.
That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.
, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.
The deceleration in new cases, however, does not apply to emergency department visits and hospital admissions. The proportion of ED visits with diagnosed COVID rose steadily throughout June and July, as 7-day averages went from 2.6% on June 1 to 6.3% on July 31 for children aged 0-11 years, from 2.1% to 3.1% for children aged 12-15, and from 2.4% to 3.5% for 16- to 17-year-olds, according to data from the Centers for Disease Control and Prevention.
The rate of new admissions with confirmed COVID, which reached 0.46 per 100,000 population for children aged 0-17 years on July 30, has more than tripled since early April, when it had fallen to 0.13 per 100,000 in the wake of the Omicron surge, the CDC reported on its COVID Data Tracker.
A smaller but more detailed sample of children from the COVID-19–Associated Hospitalization Network (COVID-NET), which covers nearly 100 counties in 14 states, indicates that the increase in new admissions is occurring almost entirely among children aged 0-4 years, who had a rate of 5.6 per 100,000 for the week of July 17-23, compared with 0.8 per 100,000 for 5- to 11-year-olds and 1.5 per 100,000 for those aged 12-17, the CDC said.
Vaccine’s summer rollout gets lukewarm reception
As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.
That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.
, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.
The deceleration in new cases, however, does not apply to emergency department visits and hospital admissions. The proportion of ED visits with diagnosed COVID rose steadily throughout June and July, as 7-day averages went from 2.6% on June 1 to 6.3% on July 31 for children aged 0-11 years, from 2.1% to 3.1% for children aged 12-15, and from 2.4% to 3.5% for 16- to 17-year-olds, according to data from the Centers for Disease Control and Prevention.
The rate of new admissions with confirmed COVID, which reached 0.46 per 100,000 population for children aged 0-17 years on July 30, has more than tripled since early April, when it had fallen to 0.13 per 100,000 in the wake of the Omicron surge, the CDC reported on its COVID Data Tracker.
A smaller but more detailed sample of children from the COVID-19–Associated Hospitalization Network (COVID-NET), which covers nearly 100 counties in 14 states, indicates that the increase in new admissions is occurring almost entirely among children aged 0-4 years, who had a rate of 5.6 per 100,000 for the week of July 17-23, compared with 0.8 per 100,000 for 5- to 11-year-olds and 1.5 per 100,000 for those aged 12-17, the CDC said.
Vaccine’s summer rollout gets lukewarm reception
As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.
That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.
HCV reinfection uncommon among people who inject drugs
The findings, which are based on prospective data from 13 countries, including the United States, and were published in Annals of Internal Medicine (2022 Aug 8. doi: 10.7326/M21-4119), should encourage physicians to treat HCV in people with a history of injection drug use, said lead author Jason Grebely, PhD. They should also pressure payers to lift reimbursement restrictions on the same population.
“Direct-acting antiviral medications for HCV infection are safe and effective among people receiving OAT and people with recent injecting-drug use,” the investigators wrote. “Concerns remain, however, that HCV reinfection may reduce the benefits of cure among people who inject drugs and compromise HCV elimination efforts.”
They explored these concerns through a 3-year extension of the phase 3 CO-STAR trial that evaluated elbasvir and grazoprevir in people consistently taking OAT. Participants in the CO-STAR trial, which had a 96% sustained virologic response rate among those who completed therapy, could elect to participate in the present study, offering a prospective look at long-term reinfection.
Out of 296 participants in the CO-STAR trial, 286 were evaluable for reinfection and 199 enrolled in the present extension. The majority were White (79.4%) and male (75.9%), with most taking methadone (79%), followed by buprenorphine (20%). At 6 months, 40 out of 191 respondents (21%) reported injection-drug use in the previous month. At the 3-year mark, 26 out of 142 respondents (18%) disclosed injection-drug use in the previous month.
For all participants in the CO-STAR trial, the overall rate of reinfection at 3 years was 1.7 per 100 person-years (95% confidence interval, 0.8-3.0), which is lower than the rate reported in systematic reviews (3.8 per 100 person-years), according to the investigators.
In the extension analysis, the 3-year reinfection rate was lower still, at 1.2 per 100 person-years. The rate was slightly higher among people who reported injection-drug use in the previous month (1.9 per 100 person-years), and slightly lower among those who did not report injection-drug use in the prior month (0.5 per 100 person-years). More pronounced differences in reinfection were observed among participants who shared needles (6.4 per 100 person-years), versus those who didn’t share needles (1.5 per 100 person years).
Low reinfection rate may help facilitate removal of reimbursement restrictions
“Most of the reinfections in this study occurred within 24 weeks of completing treatment, suggesting that this is a key period for optimizing treatment of opioid use disorder and for providing access to needle and syringe programs that have documented benefits in preventing HCV transmission,” the investigators wrote.
This is one of the largest observational studies of its kind to date, bolstered by “excellent study retention” and a “well-characterized cohort,” with findings that should prompt real-world action, said Dr. Grebely, who is head of the hepatitis C and drug use group in the viral hepatitis clinical research program at the Kirby Institute, University of New South Wales, Sydney.
“Given that reinfection has often been cited ... by some providers as a reason for not offering treatment to people receiving OAT, the low reinfection rate in this study will be incredibly important for guiding practice and ensuring therapy is not withheld from this group,” Dr. Grebely said in an interview. “In terms of policy implications, these data may also help to facilitate the removal of reimbursement restrictions based on recent drug/alcohol use criteria that are in place among many payers in the United States.”
More research needed to determine optimal intervention strategies
Carl Latkin, PhD, professor and vice chair of the department of health, behavior, and society at Johns Hopkins University, Baltimore, called the present publication a “great article and well-done study with long-term follow-up.”
Dr. Latkin, who investigates biobehavioral interventions for disadvantaged communities, said the reported rate of reinfection is “very low among a group of current and former injectors.”
Affirming Dr. Grebely’s call for supportive practices by physicians and payers, Dr. Latkin said: “The study highlights the importance of improving access to medication for opioid use disorder. This level of treatment adherence in this group is much higher than for many other medications. Given these data, it would be difficult for payers to have a rational reason for blanket restrictions for HCV treatment among people who use drugs.”
Dr. Latkin explained that “it isn’t simply injection drug use per se” that drives HCV reinfection; instead, he cited social factors, such as lack of housing, as well as withdrawal symptoms, especially among those without access to medications for opioid use disorder (MOUD).
Dr. Latkin and Grebely also agreed that more research is needed to determine optimal intervention strategies.
Dr. Grebely called for one to enhance HCV testing and linkage to care, a topic he covered in a recent review article (Lancet Gastroenterol Hepatol. 2022 May;7[5]:426-45.).
Dr. Latkin said that, while it’s clear that “syringe services programs, accessible HCV treatment, and MOUD are needed,” it is unclear how much coverage is necessary for a given population.
Findings support critical nature of needle and syringe exchange programs
Sarah M. Kattakuzhy, MD, an associate professor in the division of clinical care & research at the Institute of Human Virology, University of Maryland, Baltimore, agreed that the findings “support the critical nature of needle and syringe exchange programs.”
“As most cities in the United States fall well below the high coverage needle and syringe program threshold required to maximally prevent disease transmission, the study serves as a push toward an evidence-based harm reduction policy,” she said.
Dr. Kattakuzhy he added that the study “supports the need to longitudinally engage individuals after HCV treatment to monitor reinfection risk behaviors and test for reinfection,” she continued.
When it came to translating all the data to populations in the United States, she offered a more guarded view.
“Critically, the study population included only individuals who were engaged with OAT and adherent for 3 or more months, selecting to a population of individuals with high adherence and engagement in care,” Dr. Kattakuzhy said in an interview. “As such, the study findings are not applicable to other cross sections of the drug-using community, including individuals not engaged in OAT, and cohorts with higher rates of ongoing injection drug use. Furthermore, there are known genetic impacts on spontaneous clearance, and emerging data on the immunology of reinfection.
“Studies with a focus on less engaged, higher-risk, and minority populations with active drug use are required to answer the remaining questions in HCV reinfection,” she said.
The study was supported by Merck, the Australian Government Department of Health, and the Australian National Health and Medical Research Council. Dr. Grebely disclosed receiving funding from Cepheid, the manufacturer of the Xpert HCV assay. The other investigators disclosed additional relationships with Gilead, AbbVie, Cepheid, and others. Dr. Latkin and Dr. Kattakuzhy disclosed no relevant conflicts of interest.
The findings, which are based on prospective data from 13 countries, including the United States, and were published in Annals of Internal Medicine (2022 Aug 8. doi: 10.7326/M21-4119), should encourage physicians to treat HCV in people with a history of injection drug use, said lead author Jason Grebely, PhD. They should also pressure payers to lift reimbursement restrictions on the same population.
“Direct-acting antiviral medications for HCV infection are safe and effective among people receiving OAT and people with recent injecting-drug use,” the investigators wrote. “Concerns remain, however, that HCV reinfection may reduce the benefits of cure among people who inject drugs and compromise HCV elimination efforts.”
They explored these concerns through a 3-year extension of the phase 3 CO-STAR trial that evaluated elbasvir and grazoprevir in people consistently taking OAT. Participants in the CO-STAR trial, which had a 96% sustained virologic response rate among those who completed therapy, could elect to participate in the present study, offering a prospective look at long-term reinfection.
Out of 296 participants in the CO-STAR trial, 286 were evaluable for reinfection and 199 enrolled in the present extension. The majority were White (79.4%) and male (75.9%), with most taking methadone (79%), followed by buprenorphine (20%). At 6 months, 40 out of 191 respondents (21%) reported injection-drug use in the previous month. At the 3-year mark, 26 out of 142 respondents (18%) disclosed injection-drug use in the previous month.
For all participants in the CO-STAR trial, the overall rate of reinfection at 3 years was 1.7 per 100 person-years (95% confidence interval, 0.8-3.0), which is lower than the rate reported in systematic reviews (3.8 per 100 person-years), according to the investigators.
In the extension analysis, the 3-year reinfection rate was lower still, at 1.2 per 100 person-years. The rate was slightly higher among people who reported injection-drug use in the previous month (1.9 per 100 person-years), and slightly lower among those who did not report injection-drug use in the prior month (0.5 per 100 person-years). More pronounced differences in reinfection were observed among participants who shared needles (6.4 per 100 person-years), versus those who didn’t share needles (1.5 per 100 person years).
Low reinfection rate may help facilitate removal of reimbursement restrictions
“Most of the reinfections in this study occurred within 24 weeks of completing treatment, suggesting that this is a key period for optimizing treatment of opioid use disorder and for providing access to needle and syringe programs that have documented benefits in preventing HCV transmission,” the investigators wrote.
This is one of the largest observational studies of its kind to date, bolstered by “excellent study retention” and a “well-characterized cohort,” with findings that should prompt real-world action, said Dr. Grebely, who is head of the hepatitis C and drug use group in the viral hepatitis clinical research program at the Kirby Institute, University of New South Wales, Sydney.
“Given that reinfection has often been cited ... by some providers as a reason for not offering treatment to people receiving OAT, the low reinfection rate in this study will be incredibly important for guiding practice and ensuring therapy is not withheld from this group,” Dr. Grebely said in an interview. “In terms of policy implications, these data may also help to facilitate the removal of reimbursement restrictions based on recent drug/alcohol use criteria that are in place among many payers in the United States.”
More research needed to determine optimal intervention strategies
Carl Latkin, PhD, professor and vice chair of the department of health, behavior, and society at Johns Hopkins University, Baltimore, called the present publication a “great article and well-done study with long-term follow-up.”
Dr. Latkin, who investigates biobehavioral interventions for disadvantaged communities, said the reported rate of reinfection is “very low among a group of current and former injectors.”
Affirming Dr. Grebely’s call for supportive practices by physicians and payers, Dr. Latkin said: “The study highlights the importance of improving access to medication for opioid use disorder. This level of treatment adherence in this group is much higher than for many other medications. Given these data, it would be difficult for payers to have a rational reason for blanket restrictions for HCV treatment among people who use drugs.”
Dr. Latkin explained that “it isn’t simply injection drug use per se” that drives HCV reinfection; instead, he cited social factors, such as lack of housing, as well as withdrawal symptoms, especially among those without access to medications for opioid use disorder (MOUD).
Dr. Latkin and Grebely also agreed that more research is needed to determine optimal intervention strategies.
Dr. Grebely called for one to enhance HCV testing and linkage to care, a topic he covered in a recent review article (Lancet Gastroenterol Hepatol. 2022 May;7[5]:426-45.).
Dr. Latkin said that, while it’s clear that “syringe services programs, accessible HCV treatment, and MOUD are needed,” it is unclear how much coverage is necessary for a given population.
Findings support critical nature of needle and syringe exchange programs
Sarah M. Kattakuzhy, MD, an associate professor in the division of clinical care & research at the Institute of Human Virology, University of Maryland, Baltimore, agreed that the findings “support the critical nature of needle and syringe exchange programs.”
“As most cities in the United States fall well below the high coverage needle and syringe program threshold required to maximally prevent disease transmission, the study serves as a push toward an evidence-based harm reduction policy,” she said.
Dr. Kattakuzhy he added that the study “supports the need to longitudinally engage individuals after HCV treatment to monitor reinfection risk behaviors and test for reinfection,” she continued.
When it came to translating all the data to populations in the United States, she offered a more guarded view.
“Critically, the study population included only individuals who were engaged with OAT and adherent for 3 or more months, selecting to a population of individuals with high adherence and engagement in care,” Dr. Kattakuzhy said in an interview. “As such, the study findings are not applicable to other cross sections of the drug-using community, including individuals not engaged in OAT, and cohorts with higher rates of ongoing injection drug use. Furthermore, there are known genetic impacts on spontaneous clearance, and emerging data on the immunology of reinfection.
“Studies with a focus on less engaged, higher-risk, and minority populations with active drug use are required to answer the remaining questions in HCV reinfection,” she said.
The study was supported by Merck, the Australian Government Department of Health, and the Australian National Health and Medical Research Council. Dr. Grebely disclosed receiving funding from Cepheid, the manufacturer of the Xpert HCV assay. The other investigators disclosed additional relationships with Gilead, AbbVie, Cepheid, and others. Dr. Latkin and Dr. Kattakuzhy disclosed no relevant conflicts of interest.
The findings, which are based on prospective data from 13 countries, including the United States, and were published in Annals of Internal Medicine (2022 Aug 8. doi: 10.7326/M21-4119), should encourage physicians to treat HCV in people with a history of injection drug use, said lead author Jason Grebely, PhD. They should also pressure payers to lift reimbursement restrictions on the same population.
“Direct-acting antiviral medications for HCV infection are safe and effective among people receiving OAT and people with recent injecting-drug use,” the investigators wrote. “Concerns remain, however, that HCV reinfection may reduce the benefits of cure among people who inject drugs and compromise HCV elimination efforts.”
They explored these concerns through a 3-year extension of the phase 3 CO-STAR trial that evaluated elbasvir and grazoprevir in people consistently taking OAT. Participants in the CO-STAR trial, which had a 96% sustained virologic response rate among those who completed therapy, could elect to participate in the present study, offering a prospective look at long-term reinfection.
Out of 296 participants in the CO-STAR trial, 286 were evaluable for reinfection and 199 enrolled in the present extension. The majority were White (79.4%) and male (75.9%), with most taking methadone (79%), followed by buprenorphine (20%). At 6 months, 40 out of 191 respondents (21%) reported injection-drug use in the previous month. At the 3-year mark, 26 out of 142 respondents (18%) disclosed injection-drug use in the previous month.
For all participants in the CO-STAR trial, the overall rate of reinfection at 3 years was 1.7 per 100 person-years (95% confidence interval, 0.8-3.0), which is lower than the rate reported in systematic reviews (3.8 per 100 person-years), according to the investigators.
In the extension analysis, the 3-year reinfection rate was lower still, at 1.2 per 100 person-years. The rate was slightly higher among people who reported injection-drug use in the previous month (1.9 per 100 person-years), and slightly lower among those who did not report injection-drug use in the prior month (0.5 per 100 person-years). More pronounced differences in reinfection were observed among participants who shared needles (6.4 per 100 person-years), versus those who didn’t share needles (1.5 per 100 person years).
Low reinfection rate may help facilitate removal of reimbursement restrictions
“Most of the reinfections in this study occurred within 24 weeks of completing treatment, suggesting that this is a key period for optimizing treatment of opioid use disorder and for providing access to needle and syringe programs that have documented benefits in preventing HCV transmission,” the investigators wrote.
This is one of the largest observational studies of its kind to date, bolstered by “excellent study retention” and a “well-characterized cohort,” with findings that should prompt real-world action, said Dr. Grebely, who is head of the hepatitis C and drug use group in the viral hepatitis clinical research program at the Kirby Institute, University of New South Wales, Sydney.
“Given that reinfection has often been cited ... by some providers as a reason for not offering treatment to people receiving OAT, the low reinfection rate in this study will be incredibly important for guiding practice and ensuring therapy is not withheld from this group,” Dr. Grebely said in an interview. “In terms of policy implications, these data may also help to facilitate the removal of reimbursement restrictions based on recent drug/alcohol use criteria that are in place among many payers in the United States.”
More research needed to determine optimal intervention strategies
Carl Latkin, PhD, professor and vice chair of the department of health, behavior, and society at Johns Hopkins University, Baltimore, called the present publication a “great article and well-done study with long-term follow-up.”
Dr. Latkin, who investigates biobehavioral interventions for disadvantaged communities, said the reported rate of reinfection is “very low among a group of current and former injectors.”
Affirming Dr. Grebely’s call for supportive practices by physicians and payers, Dr. Latkin said: “The study highlights the importance of improving access to medication for opioid use disorder. This level of treatment adherence in this group is much higher than for many other medications. Given these data, it would be difficult for payers to have a rational reason for blanket restrictions for HCV treatment among people who use drugs.”
Dr. Latkin explained that “it isn’t simply injection drug use per se” that drives HCV reinfection; instead, he cited social factors, such as lack of housing, as well as withdrawal symptoms, especially among those without access to medications for opioid use disorder (MOUD).
Dr. Latkin and Grebely also agreed that more research is needed to determine optimal intervention strategies.
Dr. Grebely called for one to enhance HCV testing and linkage to care, a topic he covered in a recent review article (Lancet Gastroenterol Hepatol. 2022 May;7[5]:426-45.).
Dr. Latkin said that, while it’s clear that “syringe services programs, accessible HCV treatment, and MOUD are needed,” it is unclear how much coverage is necessary for a given population.
Findings support critical nature of needle and syringe exchange programs
Sarah M. Kattakuzhy, MD, an associate professor in the division of clinical care & research at the Institute of Human Virology, University of Maryland, Baltimore, agreed that the findings “support the critical nature of needle and syringe exchange programs.”
“As most cities in the United States fall well below the high coverage needle and syringe program threshold required to maximally prevent disease transmission, the study serves as a push toward an evidence-based harm reduction policy,” she said.
Dr. Kattakuzhy he added that the study “supports the need to longitudinally engage individuals after HCV treatment to monitor reinfection risk behaviors and test for reinfection,” she continued.
When it came to translating all the data to populations in the United States, she offered a more guarded view.
“Critically, the study population included only individuals who were engaged with OAT and adherent for 3 or more months, selecting to a population of individuals with high adherence and engagement in care,” Dr. Kattakuzhy said in an interview. “As such, the study findings are not applicable to other cross sections of the drug-using community, including individuals not engaged in OAT, and cohorts with higher rates of ongoing injection drug use. Furthermore, there are known genetic impacts on spontaneous clearance, and emerging data on the immunology of reinfection.
“Studies with a focus on less engaged, higher-risk, and minority populations with active drug use are required to answer the remaining questions in HCV reinfection,” she said.
The study was supported by Merck, the Australian Government Department of Health, and the Australian National Health and Medical Research Council. Dr. Grebely disclosed receiving funding from Cepheid, the manufacturer of the Xpert HCV assay. The other investigators disclosed additional relationships with Gilead, AbbVie, Cepheid, and others. Dr. Latkin and Dr. Kattakuzhy disclosed no relevant conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE