Infectious Diseases

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Over-the-counter medications, food supplements, and other drugs may interact with antiretroviral therapy (ART) in people living with HIV and be harmful, an industry-sponsored clinical survey from Denmark reports.

“Our study confirms that polypharmacy and being on a protease inhibitor–based regimen increase the risk of potential drug-drug interactions [PDDIs] considerably and highlights the importance of questioning people living with HIV [PLWH] about dietary supplement intake,” the authors, led by Michaela Tinggaard, MD, Copenhagen University Hospital, wrote in HIV Medicine.

“Potential drug-drug interactions were common among our study population. Although the clinical significance of the majority of the identified PDDIs may be low, most of them were avoidable through a change or discontinuation of the comedication, a change in ART or by spacing drugs,” they added.

Senior author Thomas Benfield, MD, DTMH, DMSc, a professor of infectious diseases at the University of Copenhagen, and colleagues collected information on prescription medication, over-the-counter medication, and dietary supplements from adults living with HIV who received ART from two outpatient clinics.

The researchers estimated the prevalence of non-HIV comedications, and they used the University of Liverpool HIV Drug Interactions database to identify potential drug-drug interactions. They evaluated PDDIs and used logistic regression models to investigate links between PDDIs and relevant variables.

The study included 337 people living with HIV receiving ART. The median age was 53 years, 77% of them were male, and 96% were virally suppressed, with HIV-RNA viral load less than 50 copies/mL.

Overall, 26% of participants received five or more comedications, and 56% took dietary supplements.

In the medication lists of 52% of patients, the authors identified coadministration of drugs that required dose adjustment or monitoring; 4.5% of patients were taking drugs that should not be coadministered.

The researchers detected several factors that independently predicted PDDIs:

• Male sex (odds ratio, 1.9; 95% confidence interval, 1.0-3.4)
• Being on a protease inhibitor (OR, 4.3; 95% CI, 1.9-9.7)
• Receiving five or more comedications (OR, 3.3; 95% CI, 1.5-7.2)
• Taking over-the-counter medications (OR, 1.9; 95% CI, 1.1-3.3)
• Taking dietary supplements (OR, 2.0; 95% CI, 1.2-3.3)

Comorbidities and OTC medications increase in aging people with HIV

Indira Brar, MD, an infectious diseases senior staff physician and the medical director of HIV services at Henry Ford Health in Detroit, called the study and important resource for educating providers and patients about over-the-counter drugs.

“The main strength of the study is that it includes a decent number of aging patients living with HIV, the age group in which we worry about drug interactions,” she said in an interview.

“As patients get older, they have increased comorbidities. As comorbidities increase, the number of medications increases. As the number of medications increases, the drug interactions increase,” said Dr. Brar, who was not involved in the study. “Also, as patients get older, they tend to take more over-the-counter drugs.”

Dr. Brar explained how drug-drug interactions can harm patients.

“Drugs added to a patient who is already on ART could decrease the level of the ART and cause the patient to develop a drug-resistant HIV infection,” she said. “Or the ART the patient is on can increase the levels of the new drugs that have been added, and that could have potential toxicity and side effects.

“Food supplements, including multivitamins, calcium, and magnesium, are often overlooked because we think they’re benign. But these drugs can bind our new antiretrovirals, the integrase inhibitors. They can decrease their levels in the patient and cause drug-resistant HIV infection.

“In our clinic, we always tell our patients to please call us before they take any medication, so we can make sure there is no drug interaction,” Dr. Brar said.

Nan Wang, PharmD, a clinical pharmacy specialist at University Hospitals Cleveland Medical Center, noted in an email that drug-drug interactions with ARTs are common.

“Understanding the prevalence of antiretroviral drug interactions in a patient population can help identify certain medications that require enhanced vigilance and can guide our clinical interventions,” said Dr. Wang, who was not associated with the research.

Joseph Alvarnas, MD, a hematologist and oncologist at City of Hope Comprehensive Cancer Center in Duarte, Calif., said that this is “a methodologically sound and well-designed study that’s a timely, important reminder that providers need to think carefully and comprehensively when caring for their patients living with HIV.”

Dr. Alvarnas, who was not involved in the study, said that, with the widespread availability of ART, HIV has become a chronic, manageable condition in an aging population.

“ART agents, particularly the ritonavir-boosted protease inhibitors, increase the likelihood of patients having a potentially significant drug-drug interaction with one of their chronic care medications,” he added. “Even seemingly low-risk supplements such as multivitamins may result in a negative impact upon effective ART treatment of PLWH.”

“The essential next step is that these findings are integrated carefully into decision-support systems, electronic health record prescribing systems, and pharmacy safety-check systems to ensure that we reduce the risk of patient harm,” Dr. Alvarnas advised.

Dr. Benfield and several study coauthors reported financial relationships with GlaxoSmithKline and other pharmaceutical companies. Other coauthors, as well as Dr. Alvarnas, Dr. Brar, and Dr. Wang, reported no relevant financial relationships. The study was supported by GlaxoSmithKline.

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

Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.

The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100. In trying to simplify recommendations and make immunization less expensive, the agency designated five risk levels with different advice based on the level of risk.

The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.

Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.

The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.

Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.

Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”

There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.

The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”

The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.

Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”

He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”

Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.” 

Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.

Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.

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

Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.

The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100. In trying to simplify recommendations and make immunization less expensive, the agency designated five risk levels with different advice based on the level of risk.

The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.

Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.

The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.

Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.

Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”

There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.

The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”

The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.

Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”

He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”

Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.” 

Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.

Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.

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

Each year, there are about 59,000 deaths from rabies globally. Most of these occur outside the United States and are the result of dog bites. Since infection with rabies is almost always fatal, there has been considerable attention given to vaccinating people at high risk before likely exposure and responding immediately to those bitten by a rabid animal.

The Centers for Disease Control and Prevention recently revised its preexposure prophylaxis (PrEP) recommendations for rabies. Under the previous 2008 guidelines, PrEP injections were given on days 0, 7, and 21 and cost more than $1,100. In trying to simplify recommendations and make immunization less expensive, the agency designated five risk levels with different advice based on the level of risk.

The first two groups are those with very high risk of occupational exposures – either working with rabies virus in the laboratory or working with or having contact with bats or performing animal necropsies. They are now advised to get two doses of rabies vaccine on days 0 and 7. The lab workers should have titers checked every 6 months to ensure that they remain adequately protected. And a booster should be given if the titer drops to < 0.5 IU/mL. The second group, with bat exposures, should have titers checked every 2 years.

Risk category 3 is those with long-term (> 3 years) exposure to mammals other than bats that might be rabid. This group would include veterinarians, wildlife biologists, animal control officers, and spelunkers (cavers). Category 3 also includes travelers who may encounter rabid dogs, which is not a risk in the United States. They would get the same initial two doses. The new recommendations for a third dose are based either on a titer drawn 1-3 years later being < 0.5 IU/mL or choosing to give a booster between 3 weeks and 3 years after the second dose.

The same groups are covered in risk group 4, but these are expected to have less than 3 years of potential exposure after PrEP. They would receive two doses on days 0 and 7.

Finally, group 5, at the lowest risk, includes most of the U.S. population. They do not require any PrEP.

Agam Rao, MD, CAPT, U.S. Public Health Service, CDC, told this news organization that the CDC’s Advisory Committee on Immunization Practices (ACIP) has been working on updating the 2008 rabies PrEP recommendations for several years. The committee wanted the new guideline to be “as easily followable as possible but also based on the evidence itself.”

There were two significant problems the committee tried to address. “One was that travelers who book their travel on kind of short notice don’t have enough time to get that third dose, which at the earliest can be given on day 21,” Dr. Rao said.

The second problem is that “a three-dose series [is] just really expensive. And what we found from data that had been published since the last ACIP recommendations is that fewer people than we recommend get vaccinated were getting vaccinated. So hopefully, the two-dose series helps with that.”

The ACIP used an adapted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to determine the certainty of the evidence for immunogenicity. The ACIP also used an evidence to recommendations (EtR) framework. “This incorporates a lot of other factors like the acceptability, usability, equity, all of these other variables that are important to the evidence being translated into recommendations,” Dr. Rao said. A table details their analysis.

Rabies expert Thiravat Hemachudha, MD, professor of neurology at WHO Collaborating Centre for Research and Training on Viral Zoonoses, Chulalongkorn University Hospital, Bangkok, told this news organization via email that “the ACIP relies mostly on serology, whereas the rest of the world cannot afford the test or testing may not be available.”

He added: “The issue of ‘long-term immunogenicity’ after receiving [PrEP is] an anamnestic response. All standard tissue culture rabies vaccines with appropriate dosage and route of delivery, either IM or ID, are considered safe and effective. There are many studies in Asian countries confirming that with only one primary series of PrEP, ID or IM with reduced doses, can produce immunity for as long as 20 years. Therefore, serology check is not necessary in general populations in rabies endemic countries where most of the rabies deaths occur. Investigation of all death cases was performed in Thailand and did not reveal any failure. Cases with PrEP in the past who died did not receive a booster after exposure.”

Dr. Rao offered one additional suggestion to clinicians faced with an urgent need to get a rabies titer: “They really should reach out to the lab (with all the information) before they send the specimen for the titer check ... so that the testing can be facilitated. All of these laboratories have the capacity to do stat and ASAP testing ... Clinicians do not know that they can call laboratories directly and expedite this sort of testing.” 

Dr. Rao emphasized that PrEP does not eliminate the need for postexposure prophylaxis (PEP). Still, it eliminates the need for rabies immunoglobulin and decreases the number of vaccine doses required for PEP. “I hope more people will take advantage of the titer checks and potentially save the patient some money,” she concluded.

Dr. Rao and Dr. Hemachudha have disclosed no relevant financial relationships.

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

Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.

Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.

They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.

Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.

This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.

The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
 

Messages for prevention

Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.

Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”

Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”

Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.

It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.

Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.

Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.

“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
 

Pandemic changed patterns

This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.

However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.

“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.

A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.

“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
 

Most deaths occurring outside hospitals

A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.

The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”

The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.

This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.

The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.

The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.

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

Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.

Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.

They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.

Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.

This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.

The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
 

Messages for prevention

Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.

Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”

Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”

Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.

It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.

Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.

Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.

“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
 

Pandemic changed patterns

This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.

However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.

“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.

A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.

“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
 

Most deaths occurring outside hospitals

A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.

The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”

The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.

This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.

The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.

The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.

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

Respiratory syncytial virus (RSV) caused more than 100,000 deaths in children under age 5 years globally in 2019, according to an analysis published online in The Lancet.

Researchers, led by You Li, PhD, of Nanjing (China) Medical University, found that nearly half of those (more than 45,000) occurred in children younger than 6 months old.

They estimated that RSV causes 1 in 50 deaths among children under 5 years old, and 1 in 28 deaths in children under 6 months old.

Additionally, RSV is responsible for an estimated 3.6 million hospital admissions globally each year, according to the report.

This analysis is the first to sift RSV disease burden into narrow age brackets, the authors said.

The numbers highlight that almost all of the deaths (97%) were in low- and middle-income countries.
 

Messages for prevention

Tina Hartert, MD, MPH, a professor in the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., who was not part of the study, wrote in an invited commentary that these findings will be important in RSV prevention.

Among the most notable findings, she wrote, is the heavy mortality in the 0- to 6-month age group, which she notes is “the age group targeted by vaccination during pregnancy and birth-dose immunoprophylaxis.”

Dr. Hartert, who coauthored the commentary with Justin R. Ortiz, MD, MS, with the Center for Vaccine Development and Global Health, University of Maryland, Baltimore, told this news organization, “RSV is a respiratory virus that infects nearly every child by the time they are 2-3 years of age, with severe infection and death most common in the youngest infants. Vaccines that prevent the most severe infections in these young infants will likely be one of the best ways to prevent these severe infections and death.”

Though the authors found most deaths occur in low- and middle-income countries, RSV is one of the most common reasons for infant hospitalization in the US and affects 1% to 3% of infants, half of whom are full-term and otherwise healthy, Dr. Hartert said.

It is also one of the most common causes of infant lower respiratory tract infection in young children in the United States, she said, and it causes the most severe disease at the age extremes, with older adults experiencing significant morbidity with RSV.

Dr. Li said in an interview that although the team did not focus on reporting country-specific estimates in this work, their previous work, resulted in estimates of 98,000-155,000 RSV-related hospitalizations in children under 5 years old in the United States in 2019. Between 65,000 and 86,000 were in infants less than 1 year old.

Currently, he said, the only available RSV prophylaxis is palivizumab (Synagis), which is expensive and given only to high-risk infants in high-income countries, including the United States.

“There have been a number of promising RSV prophylactic products including maternal vaccine and monoclonal antibodies that have the potential for targeting the general infant population – not just high-risk infants – in late-phase clinical trials,” he said. “Our estimates of RSV-related disease burden will help anticipate the impact of future RSV immunization programs.”
 

Pandemic changed patterns

This research was completed before the COVID-19 pandemic, and it is not yet known how that could affect RSV disease burden long term.

However, Dr. Hartert said, RSV circulation has been significantly changed during the pandemic, both in intensity and timing, likely because of a combination of COVID and the public health preventive measures.

“As people return to normal activities and the public health measures put in place to stop the spread of COVID are eased, we are likely to see increases in circulation of RSV and return to its circulation during the winter months – typically similar to circulation of flu – from November through March in temperate climates in the northern hemisphere,” she said.

A coauthor of the paper, Harish Nair, PhD, with the Centre for Global Health, Usher Institute, University of Edinburgh, said in a press release that their findings have particular significance as COVID restrictions ease around the globe.

“The majority of the young children born in the last 2 years have never been exposed to RSV (and therefore have no immunity against this virus),” Nair wrote.
 

Most deaths occurring outside hospitals

A challenge in reducing the deaths in those 5 years old and younger is that most (76%) of deaths are happening in the community outside hospitals.

The authors wrote: “For every RSV-associated acute lower respiratory infection in-hospital death, we estimate approximately three more deaths attributable to RSV in the community.”

The percentage dying outside hospitals is even larger (81%) in low- to middle-income countries.

This work built on a previous review by the team that analyzed 317 studies. They updated their search with 113 new eligible studies and unpublished data from 51 papers published between Jan. 1, 2017, and Dec. 31, 2020.

The authors acknowledged some limitations, including variations in study settings and in definitions for acute lower respiratory infection, healthcare access, and eligibility for RSV testing.

The study was funded by EU Innovative Medicines Initiative Respiratory Syncytial Virus Consortium in Europe. Dr. Li reported grants from Wellcome Trust and the World Health Organization outside the submitted work. Dr. Hartert, Dr. Ortiz, and Dr. Nair disclosed no relevant financial relationships.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, signed off May 19 on an advisory panel’s recommendation that children ages 5 to 11 years should receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11:1, with one abstention, on a question about whether it recommended these additional shots in this age group.

The U.S. Food and Drug Administration on May 17 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover a single booster dose for administration to individuals 5 through 11 years of age.

At the request of CDC staff, ACIP members considered whether there should be softer wording for this recommendation, stating that children in this age group “may” receive a booster. This kind of phrasing would better reflect uncertainty about the course of COVID in the months ahead and allow flexibility for a stronger recommendation in the fall.

ACIP panelists and members of key groups argued strongly for a “should” recommendation, despite the uncertainties.

They also called for stronger efforts to make sure eligible children received their initial COVID-19 shots. Data gathered between November and April show only 14.4% of children ages 5 to 11 in rural areas have received at least one dose of COVID-19 vaccination, with top rates of 39.8% in large urban communities and 36% in larger suburban regions, CDC staff said.

CDC staff also said nearly 40% of parents in rural areas reported that their children’s pediatricians did not recommend COVID-19 vaccinations, compared with only 8% of parents in urban communities. These figures concerned ACIP members and liaisons from medical associations who take part in the panel’s deliberations but not in its votes.

“People will hear the word ‘m-a-y’ as ‘m-e-h’,” said Patricia Stinchfield, RN, MS, who served as the liaison for National Association of Pediatric Nurse Practitioners to ACIP. “I think we need to add urgency” to efforts to increase use of COVID vaccinations, she said.

Voting no on Thursday was Helen Keipp Talbot, MD, of Vanderbilt University. She explained after the vote that she is in favor of having young children vaccinated, but she’s concerned about the low rates of initial uptake of the COVID-19 shots.

“Boosters are great once we’ve gotten everyone their first round,” she said. “That needs to be our priority in this.”

Sandra Fryhofer, MD, the American Medical Association’s liaison to ACIP, stressed the add-on benefits from more widespread vaccination of children against COVID. Dr. Fryhofer said she serves adults in her practice as an internal medicine physician, with many of her patients being at high risk for complications from COVID.

Too many people are assuming the spread of infections in the community has lessened the risk of the virus, Dr. Fryhofer said.

“Not everyone’s had COVID yet, and my patients will be likely to get COVID if their grandchildren get it. We’re going through pandemic fatigue in this country,” she said. “Unfortunately, masks are now more off than on. Winter’s coming. They’re more variants” of the virus likely to emerge.

The data emerging so far suggests COVID vaccines will become a three-dose medicine, as is already accepted for other shots like hepatitis B vaccine, Dr. Fryhofer said.

Data gathered to date show the vaccine decreases risk of hospitalization for COVID and for complications such as multisystem inflammatory syndrome in children (MIS-C), she said.

“The bottom line is children in this age group are getting COVID,” Dr. Fryhofer said of the 5- to 11-year-olds. “Some do fine. Some are getting real sick. Some are hospitalized, some have died.”

At the meeting, CDC staff cited data from a paper published in the New England Journal of Medicine in March showing that vaccination had reduced the risk of hospitalization for COVID-19 among children 5 to 11 years of age by two-thirds during the Omicron period; most children with critical COVID-19 were unvaccinated.

COVID-19 led to 66 deaths among children ages 5 to 11 in the October 2020 to October 2021 timeframe, said ACIP member Matthew F. Daley, MD, of Kaiser Permanente Colorado during a presentation to his fellow panel members.

Parents may underestimate children’s risk from COVID and thus hold off on vaccinations, stressed AMA President Gerald E. Harmon, MD, in a statement issued after the meeting.

“It is concerning that only 1 in 3 children between the ages of 5 and 11 in the United States have received two doses of the vaccine, in part because parents believe them to be at lower risk for severe disease than adults,” Dr. Harmon said. “But the Omicron variant brought about change that should alter that calculus.”
 

Responding to early data

As Dr. Fryhofer put it, the medical community has been learning in “real time” about how COVID vaccines work and how to use them.

The EUA granted on May 17 for booster shots for children ages 5 to 11 was based on an analysis of immune response data in a subset of children from an ongoing randomized placebo-controlled trial, the FDA said.

Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The EUA for the booster shot was intended to respond to emerging data that suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine, the FDA said.
 

CDC seeks help tracking vaccine complications

At the ACIP meeting, a top CDC vaccine-safety official, Tom Shimabukuro, MD, MPH, MBA, asked physicians to make sure their patients know about the agency’s V-Safe program for gathering reports from the public about their experiences with COVID vaccines. This is intended to help the CDC monitor for side effects of these medications.

“We need your help,” he said during a presentation about adverse events reported to date in children ages 5 to 11 who took the Pfizer vaccine.

About 18.1 million doses of Pfizer-BioNTech vaccine have been administered to children ages 5 to 11 years in the United States so far. Most of the reports of adverse events following vaccination were not serious, he said. But there were 20 reports of myocarditis verified to meet CDC case definition among children ages 5 to 11 years.

One case involved a death with histopathologic evidence of myocarditis on autopsy. The CDC continues to assist with case review, he said.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Twelve years after the human papillomavirus (HPV) vaccination program was introduced in the United States, the overall prevalence of cancer-causing HPV strains covered by the vaccine dropped by 85% among females – 90% among vaccinated females and 74% among unvaccinated females – a strong sign of herd immunity, a new analysis of a nationally representative database is showing.

“HPV vaccination is working well,” Hannah Rosenblum, MD, Centers for Disease Control and Prevention, Atlanta, told this news organization in an email.

“Twelve years after introduction of HPV vaccination in the United States, national data demonstrate increasing impact among females and strong herd effects among unvaccinated females,” she added. “[Although] vaccination coverage and completion of the recommended dose in the United States is lower than coverage with other adolescent vaccinations, HPV vaccination is the best way to prevent HPV infections that can lead to several cancers in both females and males.”

The study was published online in Annals of Internal Medicine.
 

NHANES survey

The authors used data from the National Health and Nutrition Examination Survey (NHANES) to examine the four HPV types in the quadrivalent vaccine before 2003 and 2006 (the pre-vaccine era) and then again between 2007-2010, 2011-2014, and 2015-2018 (the vaccine era). For females, they analyzed demographic and HPV prevalence data across each 4-year era.

“Analyses were limited to sexually experienced participants, to ensure that all those included had an opportunity for HPV exposure, and to participants aged 14-24 years with adequate self-collected cervicovaginal specimens,” the authors explain.

This resulted in a sample size of 3,197 females. Demographic and HPV prevalence data were also collected from males but only during the 2013-2016 era, because those are the only years for which male HPV typing data are available in NHANES. Again, analyses were limited to sexually experienced males aged 14-24 years with adequate self-collected penile specimens, which resulted in a sample size of 661 males.

Over the 12 years of follow-up for females, there was a steady increase in females reporting having received at least one dose of the HPV vaccine – from slightly over 25% during 2007-12 to 59% during 2015-2018. The percentage of males who reported having at least one HPV dose also increased, from 29.5% in 2016 to 34.5% in 2018.

During the earliest vaccine era (2007-2010), the prevalence of the four HPV strains covered by the vaccine was 7.3% among vaccinated females, compared with 20.4% among unvaccinated females. “By 2015 to 2018, the prevalence was 2.8% (prevalence ratio, 0.16; 95% confidence interval, 0.07-0.39). The prevalence of the four vaccine-covered types was only 1.9% in vaccinated females, compared with 4.8% in unvaccinated females (PR, 0.40; 95% CI, 0.11-1.41).

In contrast, the prevalence of HPV types that were not covered by the vaccine showed little change – from 51.1% in the pre-vaccine era to 47.6% during 2015-2018 (PR, 0.93; 95% CI, 0.80-1.08). The authors considered this a good sign because it indicates that vaccine-type HPV infections are not being replaced with other oncogenic HPV infections. Between 2013 and 2016, the difference in the prevalence of the four HPV vaccine types was smaller at 1.8% among vaccinated males and 3.5% among unvaccinated males (PR, 0.49; 95% CI, 0.11-2.20).

Again, the prevalence of non-HPV vaccine types was not significantly different between vaccinated and unvaccinated males: 30.7% versus 34.3%.

During the vaccine era, effectiveness for females ranged from 60% to 84%. For males, vaccine effectiveness could only be evaluated for the single 4-year period from 2013 to 2016, and it was estimated at 51%. Dr. Rosenblum noted that vaccine efficacy estimates were lower on this national survey than the almost 100% efficacy rates observed in clinical trials in both males and females.

“This might be due in part to many participants receiving the vaccine at an older age than is recommended when they could have been infected [with HPV] at the time of vaccination,” Dr. Rosenblum said. She also noted that because males were incorporated into the HPV vaccination program years after females, they likely also experienced strong herd effects from the vaccine, making it challenging to estimate vaccine effectiveness.

Dr. Rosenblum also noted that there have already been documented declines in cervical precancers and high-grade vulvar and vaginal precancers, as well as genital warts and juvenile-onset recurrent respiratory papillomatosis. At the same time, the incidence of cervical precancers has recently declined among U.S. females in their late teens and early 20s – “likely reflecting the impact of vaccination,” she said.

“This study is good news for the United States HPV vaccination program, and all efforts are needed to ensure that children and adolescents receive routinely recommended vaccinations [including vaccination against HPV],” Dr. Rosenblum added.
 

Editorial comment

Commenting on the findings, Rebecca Perkins, MD, Boston University School of Medicine, and colleagues point out that the COVID-19 pandemic has led to disruptions in HPV vaccination programs and has reversed much of the progress made in recent years. “During the pandemic, providers and health systems have deprioritized adolescent vaccination and particularly HPV vaccination, which in turn has led to more severe drops for HPV vaccination than for other adolescent vaccinations, and for adolescent vaccination, compared with early childhood and adult vaccinations,” Dr. Perkins and colleagues write in an accompanying editorial.

Thus, the need to compensate for the cumulative deficit of missed vaccinations over the past 2 years has created a “serious and urgent threat” to cancer prevention efforts – “a shortfall from which it may take a decade to recover,” the editorialists predict. To try and reverse this trend, several practices have been shown to improve HPV vaccination rates.

The first is a strong provider recommendation such as, “Your child is due for an HPV vaccine today.” The second is to give standing orders to allow nurses and medical assistants to administer vaccinations without requiring intervention by a physician. Lastly, programs to remind patients when vaccines are due and to recall them for appointments also work well.

“Using evidence-based methods and redoubling our efforts to prioritize HPV vaccination will be crucial to ensuring that we do not lose a generation to preventable HPV-associated cancer,” write Dr. Perkins and colleagues.

The study authors and editorialists have disclosed no relevant financial relationships.

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

Twelve years after the human papillomavirus (HPV) vaccination program was introduced in the United States, the overall prevalence of cancer-causing HPV strains covered by the vaccine dropped by 85% among females – 90% among vaccinated females and 74% among unvaccinated females – a strong sign of herd immunity, a new analysis of a nationally representative database is showing.

“HPV vaccination is working well,” Hannah Rosenblum, MD, Centers for Disease Control and Prevention, Atlanta, told this news organization in an email.

“Twelve years after introduction of HPV vaccination in the United States, national data demonstrate increasing impact among females and strong herd effects among unvaccinated females,” she added. “[Although] vaccination coverage and completion of the recommended dose in the United States is lower than coverage with other adolescent vaccinations, HPV vaccination is the best way to prevent HPV infections that can lead to several cancers in both females and males.”

The study was published online in Annals of Internal Medicine.
 

NHANES survey

The authors used data from the National Health and Nutrition Examination Survey (NHANES) to examine the four HPV types in the quadrivalent vaccine before 2003 and 2006 (the pre-vaccine era) and then again between 2007-2010, 2011-2014, and 2015-2018 (the vaccine era). For females, they analyzed demographic and HPV prevalence data across each 4-year era.

“Analyses were limited to sexually experienced participants, to ensure that all those included had an opportunity for HPV exposure, and to participants aged 14-24 years with adequate self-collected cervicovaginal specimens,” the authors explain.

This resulted in a sample size of 3,197 females. Demographic and HPV prevalence data were also collected from males but only during the 2013-2016 era, because those are the only years for which male HPV typing data are available in NHANES. Again, analyses were limited to sexually experienced males aged 14-24 years with adequate self-collected penile specimens, which resulted in a sample size of 661 males.

Over the 12 years of follow-up for females, there was a steady increase in females reporting having received at least one dose of the HPV vaccine – from slightly over 25% during 2007-12 to 59% during 2015-2018. The percentage of males who reported having at least one HPV dose also increased, from 29.5% in 2016 to 34.5% in 2018.

During the earliest vaccine era (2007-2010), the prevalence of the four HPV strains covered by the vaccine was 7.3% among vaccinated females, compared with 20.4% among unvaccinated females. “By 2015 to 2018, the prevalence was 2.8% (prevalence ratio, 0.16; 95% confidence interval, 0.07-0.39). The prevalence of the four vaccine-covered types was only 1.9% in vaccinated females, compared with 4.8% in unvaccinated females (PR, 0.40; 95% CI, 0.11-1.41).

In contrast, the prevalence of HPV types that were not covered by the vaccine showed little change – from 51.1% in the pre-vaccine era to 47.6% during 2015-2018 (PR, 0.93; 95% CI, 0.80-1.08). The authors considered this a good sign because it indicates that vaccine-type HPV infections are not being replaced with other oncogenic HPV infections. Between 2013 and 2016, the difference in the prevalence of the four HPV vaccine types was smaller at 1.8% among vaccinated males and 3.5% among unvaccinated males (PR, 0.49; 95% CI, 0.11-2.20).

Again, the prevalence of non-HPV vaccine types was not significantly different between vaccinated and unvaccinated males: 30.7% versus 34.3%.

During the vaccine era, effectiveness for females ranged from 60% to 84%. For males, vaccine effectiveness could only be evaluated for the single 4-year period from 2013 to 2016, and it was estimated at 51%. Dr. Rosenblum noted that vaccine efficacy estimates were lower on this national survey than the almost 100% efficacy rates observed in clinical trials in both males and females.

“This might be due in part to many participants receiving the vaccine at an older age than is recommended when they could have been infected [with HPV] at the time of vaccination,” Dr. Rosenblum said. She also noted that because males were incorporated into the HPV vaccination program years after females, they likely also experienced strong herd effects from the vaccine, making it challenging to estimate vaccine effectiveness.

Dr. Rosenblum also noted that there have already been documented declines in cervical precancers and high-grade vulvar and vaginal precancers, as well as genital warts and juvenile-onset recurrent respiratory papillomatosis. At the same time, the incidence of cervical precancers has recently declined among U.S. females in their late teens and early 20s – “likely reflecting the impact of vaccination,” she said.

“This study is good news for the United States HPV vaccination program, and all efforts are needed to ensure that children and adolescents receive routinely recommended vaccinations [including vaccination against HPV],” Dr. Rosenblum added.
 

Editorial comment

Commenting on the findings, Rebecca Perkins, MD, Boston University School of Medicine, and colleagues point out that the COVID-19 pandemic has led to disruptions in HPV vaccination programs and has reversed much of the progress made in recent years. “During the pandemic, providers and health systems have deprioritized adolescent vaccination and particularly HPV vaccination, which in turn has led to more severe drops for HPV vaccination than for other adolescent vaccinations, and for adolescent vaccination, compared with early childhood and adult vaccinations,” Dr. Perkins and colleagues write in an accompanying editorial.

Thus, the need to compensate for the cumulative deficit of missed vaccinations over the past 2 years has created a “serious and urgent threat” to cancer prevention efforts – “a shortfall from which it may take a decade to recover,” the editorialists predict. To try and reverse this trend, several practices have been shown to improve HPV vaccination rates.

The first is a strong provider recommendation such as, “Your child is due for an HPV vaccine today.” The second is to give standing orders to allow nurses and medical assistants to administer vaccinations without requiring intervention by a physician. Lastly, programs to remind patients when vaccines are due and to recall them for appointments also work well.

“Using evidence-based methods and redoubling our efforts to prioritize HPV vaccination will be crucial to ensuring that we do not lose a generation to preventable HPV-associated cancer,” write Dr. Perkins and colleagues.

The study authors and editorialists have disclosed no relevant financial relationships.

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

Twelve years after the human papillomavirus (HPV) vaccination program was introduced in the United States, the overall prevalence of cancer-causing HPV strains covered by the vaccine dropped by 85% among females – 90% among vaccinated females and 74% among unvaccinated females – a strong sign of herd immunity, a new analysis of a nationally representative database is showing.

“HPV vaccination is working well,” Hannah Rosenblum, MD, Centers for Disease Control and Prevention, Atlanta, told this news organization in an email.

“Twelve years after introduction of HPV vaccination in the United States, national data demonstrate increasing impact among females and strong herd effects among unvaccinated females,” she added. “[Although] vaccination coverage and completion of the recommended dose in the United States is lower than coverage with other adolescent vaccinations, HPV vaccination is the best way to prevent HPV infections that can lead to several cancers in both females and males.”

The study was published online in Annals of Internal Medicine.
 

NHANES survey

The authors used data from the National Health and Nutrition Examination Survey (NHANES) to examine the four HPV types in the quadrivalent vaccine before 2003 and 2006 (the pre-vaccine era) and then again between 2007-2010, 2011-2014, and 2015-2018 (the vaccine era). For females, they analyzed demographic and HPV prevalence data across each 4-year era.

“Analyses were limited to sexually experienced participants, to ensure that all those included had an opportunity for HPV exposure, and to participants aged 14-24 years with adequate self-collected cervicovaginal specimens,” the authors explain.

This resulted in a sample size of 3,197 females. Demographic and HPV prevalence data were also collected from males but only during the 2013-2016 era, because those are the only years for which male HPV typing data are available in NHANES. Again, analyses were limited to sexually experienced males aged 14-24 years with adequate self-collected penile specimens, which resulted in a sample size of 661 males.

Over the 12 years of follow-up for females, there was a steady increase in females reporting having received at least one dose of the HPV vaccine – from slightly over 25% during 2007-12 to 59% during 2015-2018. The percentage of males who reported having at least one HPV dose also increased, from 29.5% in 2016 to 34.5% in 2018.

During the earliest vaccine era (2007-2010), the prevalence of the four HPV strains covered by the vaccine was 7.3% among vaccinated females, compared with 20.4% among unvaccinated females. “By 2015 to 2018, the prevalence was 2.8% (prevalence ratio, 0.16; 95% confidence interval, 0.07-0.39). The prevalence of the four vaccine-covered types was only 1.9% in vaccinated females, compared with 4.8% in unvaccinated females (PR, 0.40; 95% CI, 0.11-1.41).

In contrast, the prevalence of HPV types that were not covered by the vaccine showed little change – from 51.1% in the pre-vaccine era to 47.6% during 2015-2018 (PR, 0.93; 95% CI, 0.80-1.08). The authors considered this a good sign because it indicates that vaccine-type HPV infections are not being replaced with other oncogenic HPV infections. Between 2013 and 2016, the difference in the prevalence of the four HPV vaccine types was smaller at 1.8% among vaccinated males and 3.5% among unvaccinated males (PR, 0.49; 95% CI, 0.11-2.20).

Again, the prevalence of non-HPV vaccine types was not significantly different between vaccinated and unvaccinated males: 30.7% versus 34.3%.

During the vaccine era, effectiveness for females ranged from 60% to 84%. For males, vaccine effectiveness could only be evaluated for the single 4-year period from 2013 to 2016, and it was estimated at 51%. Dr. Rosenblum noted that vaccine efficacy estimates were lower on this national survey than the almost 100% efficacy rates observed in clinical trials in both males and females.

“This might be due in part to many participants receiving the vaccine at an older age than is recommended when they could have been infected [with HPV] at the time of vaccination,” Dr. Rosenblum said. She also noted that because males were incorporated into the HPV vaccination program years after females, they likely also experienced strong herd effects from the vaccine, making it challenging to estimate vaccine effectiveness.

Dr. Rosenblum also noted that there have already been documented declines in cervical precancers and high-grade vulvar and vaginal precancers, as well as genital warts and juvenile-onset recurrent respiratory papillomatosis. At the same time, the incidence of cervical precancers has recently declined among U.S. females in their late teens and early 20s – “likely reflecting the impact of vaccination,” she said.

“This study is good news for the United States HPV vaccination program, and all efforts are needed to ensure that children and adolescents receive routinely recommended vaccinations [including vaccination against HPV],” Dr. Rosenblum added.
 

Editorial comment

Commenting on the findings, Rebecca Perkins, MD, Boston University School of Medicine, and colleagues point out that the COVID-19 pandemic has led to disruptions in HPV vaccination programs and has reversed much of the progress made in recent years. “During the pandemic, providers and health systems have deprioritized adolescent vaccination and particularly HPV vaccination, which in turn has led to more severe drops for HPV vaccination than for other adolescent vaccinations, and for adolescent vaccination, compared with early childhood and adult vaccinations,” Dr. Perkins and colleagues write in an accompanying editorial.

Thus, the need to compensate for the cumulative deficit of missed vaccinations over the past 2 years has created a “serious and urgent threat” to cancer prevention efforts – “a shortfall from which it may take a decade to recover,” the editorialists predict. To try and reverse this trend, several practices have been shown to improve HPV vaccination rates.

The first is a strong provider recommendation such as, “Your child is due for an HPV vaccine today.” The second is to give standing orders to allow nurses and medical assistants to administer vaccinations without requiring intervention by a physician. Lastly, programs to remind patients when vaccines are due and to recall them for appointments also work well.

“Using evidence-based methods and redoubling our efforts to prioritize HPV vaccination will be crucial to ensuring that we do not lose a generation to preventable HPV-associated cancer,” write Dr. Perkins and colleagues.

The study authors and editorialists have disclosed no relevant financial relationships.

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

Pre-procedure urinalysis can be skipped before certain office-based urology procedures, such as prostate biopsy and cystoscopy, according to the results of a randomized trial.

Some centers perform the pre-procedure test to avoid urinary tract infections (UTIs), a feared iatrogenic complication, but the new findings indicate the step is unnecessary.

These results “will alter screening urinalysis practice at our hospital,” said Alexa Rose, a clinical research coordinator in the department of urology, University of Wisconsin School of Medicine and Public Health, Madison. Ms. Rose’s group presented the findings at the annual meeting of the American Urological Association.

Although rates of post procedure UTI are generally low after office-based cytology, it is the most common complication, Ms. Rose said. To minimize risk, preprocedural urinalysis had become standard practice at her institution.

For the study, Ms. Rose and colleagues sought to determine if the testing was indeed helping reduce the risk of UTI. They randomly divided 641 patients into two groups. Both received urinalysis, but test results of participants in the experimental group were not forwarded to clinicians.

Patients were undergoing one of three types of office urology procedures: cystoscopy (66.6%), intravesical therapy for bladder cancer (24.5%), and prostate biopsy (8.9%). Median age was 70 years and most participants (83%) were men.

The primary endpoint was a symptomatic UTI confirmed by culture 30 days after the procedure.

In the 323 patients managed without access to the results of urinalysis, the rate of UTI was 1.2%. In the 318 patients who received usual care guided by urinalysis, the rate of UTI was 1.6% – and the difference was a single case.

The nonsignificant difference fell easily within the study definition of noninferiority, according to Ms. Rose. Others offering preprocedural urinalysis should take heed.

“Due to the large cohort of patients we enrolled, we expect that it will be applicable to other institutions,” she said in an interview.
 

SUB: Expert pushes back

In a 2020 Best Practice Statement from the AUA on antibiotic prophylaxis, the risk of procedural-related UTI was considered to be much lower in out-patient versus in-patient settings.

The statement identified a long list of variables to guide screening for UTI and initiation of prophylactic antibiotics prior to urology procedures for hospitalized patients, but office-based procedures in low-risk, largely healthy patients were treated differently.

As a result, the operating hypothesis of the Wisconsin study is “flawed,” said Anthony J. Schaeffer, MD, professor of urology, Feinberg School of Medicine at Northwestern University, Chicago.

“An asymptomatic patient undergoing office cystoscopy for [such indications as] hematuria or bladder tumor doesn’t need pre-procedural urinalysis or prophylactic antibiotics unless they have risk factors, such as immunosuppression,” Dr. Schaeffer told this news organization. “There is no relationship between preprocedural urinalysis and a post-procedure UTI caused by instrumentation.”

According to the AUA, neither antibiotic prophylaxis nor screening such as urodynamic studies is recommended prior to simple outpatient cystoscopy if patients are otherwise healthy and have no signs or symptoms of a UTI.

While antibiotic prophylaxis is standard of care for some outpatient urological procedures, such as transrectal ultrasound (TRUS)-guided prostate biopsies, the practice is appropriate whether or not patients undergo urinalysis, according to Dr. Schaeffer.

As a result, one problem with the new study was the lack of discussion about antibiotic prophylaxis.

“Presumably the patients undergoing TRUS prostate biopsies received antibiotic prophylaxis, which is a critical cofounder that they do not even mention,” Dr. Schaeffer said.

In patients with UTI symptoms, some screening is appropriate whether with a simple dipstick, laboratory-performed microscopy, or culture, according to the AUA.

In the absence of symptoms for a patient undergoing a class I (clean) procedure, the AUA statement recommends – and Dr. Schaeffer said he agreed – that antibiotic prophylaxis, let alone urinalysis, is not a standard, particularly for simple outpatient cystoscopy.

Ms. Rose and Dr. Schaeffer have reported no relevant financial relationships.

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

Pre-procedure urinalysis can be skipped before certain office-based urology procedures, such as prostate biopsy and cystoscopy, according to the results of a randomized trial.

Some centers perform the pre-procedure test to avoid urinary tract infections (UTIs), a feared iatrogenic complication, but the new findings indicate the step is unnecessary.

These results “will alter screening urinalysis practice at our hospital,” said Alexa Rose, a clinical research coordinator in the department of urology, University of Wisconsin School of Medicine and Public Health, Madison. Ms. Rose’s group presented the findings at the annual meeting of the American Urological Association.

Although rates of post procedure UTI are generally low after office-based cytology, it is the most common complication, Ms. Rose said. To minimize risk, preprocedural urinalysis had become standard practice at her institution.

For the study, Ms. Rose and colleagues sought to determine if the testing was indeed helping reduce the risk of UTI. They randomly divided 641 patients into two groups. Both received urinalysis, but test results of participants in the experimental group were not forwarded to clinicians.

Patients were undergoing one of three types of office urology procedures: cystoscopy (66.6%), intravesical therapy for bladder cancer (24.5%), and prostate biopsy (8.9%). Median age was 70 years and most participants (83%) were men.

The primary endpoint was a symptomatic UTI confirmed by culture 30 days after the procedure.

In the 323 patients managed without access to the results of urinalysis, the rate of UTI was 1.2%. In the 318 patients who received usual care guided by urinalysis, the rate of UTI was 1.6% – and the difference was a single case.

The nonsignificant difference fell easily within the study definition of noninferiority, according to Ms. Rose. Others offering preprocedural urinalysis should take heed.

“Due to the large cohort of patients we enrolled, we expect that it will be applicable to other institutions,” she said in an interview.
 

SUB: Expert pushes back

In a 2020 Best Practice Statement from the AUA on antibiotic prophylaxis, the risk of procedural-related UTI was considered to be much lower in out-patient versus in-patient settings.

The statement identified a long list of variables to guide screening for UTI and initiation of prophylactic antibiotics prior to urology procedures for hospitalized patients, but office-based procedures in low-risk, largely healthy patients were treated differently.

As a result, the operating hypothesis of the Wisconsin study is “flawed,” said Anthony J. Schaeffer, MD, professor of urology, Feinberg School of Medicine at Northwestern University, Chicago.

“An asymptomatic patient undergoing office cystoscopy for [such indications as] hematuria or bladder tumor doesn’t need pre-procedural urinalysis or prophylactic antibiotics unless they have risk factors, such as immunosuppression,” Dr. Schaeffer told this news organization. “There is no relationship between preprocedural urinalysis and a post-procedure UTI caused by instrumentation.”

According to the AUA, neither antibiotic prophylaxis nor screening such as urodynamic studies is recommended prior to simple outpatient cystoscopy if patients are otherwise healthy and have no signs or symptoms of a UTI.

While antibiotic prophylaxis is standard of care for some outpatient urological procedures, such as transrectal ultrasound (TRUS)-guided prostate biopsies, the practice is appropriate whether or not patients undergo urinalysis, according to Dr. Schaeffer.

As a result, one problem with the new study was the lack of discussion about antibiotic prophylaxis.

“Presumably the patients undergoing TRUS prostate biopsies received antibiotic prophylaxis, which is a critical cofounder that they do not even mention,” Dr. Schaeffer said.

In patients with UTI symptoms, some screening is appropriate whether with a simple dipstick, laboratory-performed microscopy, or culture, according to the AUA.

In the absence of symptoms for a patient undergoing a class I (clean) procedure, the AUA statement recommends – and Dr. Schaeffer said he agreed – that antibiotic prophylaxis, let alone urinalysis, is not a standard, particularly for simple outpatient cystoscopy.

Ms. Rose and Dr. Schaeffer have reported no relevant financial relationships.

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

Pre-procedure urinalysis can be skipped before certain office-based urology procedures, such as prostate biopsy and cystoscopy, according to the results of a randomized trial.

Some centers perform the pre-procedure test to avoid urinary tract infections (UTIs), a feared iatrogenic complication, but the new findings indicate the step is unnecessary.

These results “will alter screening urinalysis practice at our hospital,” said Alexa Rose, a clinical research coordinator in the department of urology, University of Wisconsin School of Medicine and Public Health, Madison. Ms. Rose’s group presented the findings at the annual meeting of the American Urological Association.

Although rates of post procedure UTI are generally low after office-based cytology, it is the most common complication, Ms. Rose said. To minimize risk, preprocedural urinalysis had become standard practice at her institution.

For the study, Ms. Rose and colleagues sought to determine if the testing was indeed helping reduce the risk of UTI. They randomly divided 641 patients into two groups. Both received urinalysis, but test results of participants in the experimental group were not forwarded to clinicians.

Patients were undergoing one of three types of office urology procedures: cystoscopy (66.6%), intravesical therapy for bladder cancer (24.5%), and prostate biopsy (8.9%). Median age was 70 years and most participants (83%) were men.

The primary endpoint was a symptomatic UTI confirmed by culture 30 days after the procedure.

In the 323 patients managed without access to the results of urinalysis, the rate of UTI was 1.2%. In the 318 patients who received usual care guided by urinalysis, the rate of UTI was 1.6% – and the difference was a single case.

The nonsignificant difference fell easily within the study definition of noninferiority, according to Ms. Rose. Others offering preprocedural urinalysis should take heed.

“Due to the large cohort of patients we enrolled, we expect that it will be applicable to other institutions,” she said in an interview.
 

SUB: Expert pushes back

In a 2020 Best Practice Statement from the AUA on antibiotic prophylaxis, the risk of procedural-related UTI was considered to be much lower in out-patient versus in-patient settings.

The statement identified a long list of variables to guide screening for UTI and initiation of prophylactic antibiotics prior to urology procedures for hospitalized patients, but office-based procedures in low-risk, largely healthy patients were treated differently.

As a result, the operating hypothesis of the Wisconsin study is “flawed,” said Anthony J. Schaeffer, MD, professor of urology, Feinberg School of Medicine at Northwestern University, Chicago.

“An asymptomatic patient undergoing office cystoscopy for [such indications as] hematuria or bladder tumor doesn’t need pre-procedural urinalysis or prophylactic antibiotics unless they have risk factors, such as immunosuppression,” Dr. Schaeffer told this news organization. “There is no relationship between preprocedural urinalysis and a post-procedure UTI caused by instrumentation.”

According to the AUA, neither antibiotic prophylaxis nor screening such as urodynamic studies is recommended prior to simple outpatient cystoscopy if patients are otherwise healthy and have no signs or symptoms of a UTI.

While antibiotic prophylaxis is standard of care for some outpatient urological procedures, such as transrectal ultrasound (TRUS)-guided prostate biopsies, the practice is appropriate whether or not patients undergo urinalysis, according to Dr. Schaeffer.

As a result, one problem with the new study was the lack of discussion about antibiotic prophylaxis.

“Presumably the patients undergoing TRUS prostate biopsies received antibiotic prophylaxis, which is a critical cofounder that they do not even mention,” Dr. Schaeffer said.

In patients with UTI symptoms, some screening is appropriate whether with a simple dipstick, laboratory-performed microscopy, or culture, according to the AUA.

In the absence of symptoms for a patient undergoing a class I (clean) procedure, the AUA statement recommends – and Dr. Schaeffer said he agreed – that antibiotic prophylaxis, let alone urinalysis, is not a standard, particularly for simple outpatient cystoscopy.

Ms. Rose and Dr. Schaeffer have reported no relevant financial relationships.

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

Use of oral ondansetron for acute gastroenteritis in children in an emergency setting increased significantly between 2006 and 2018, but use of intravenous fluids remained consistent, based on data from a cross-sectional analysis.

Recommendations for managing acute gastroenteritis in children include oral rehydration therapy for mild to moderate cases and intravenous rehydration for severe cases, Brett Burstein, MDCM, of McGill University, Montreal, and colleagues wrote.

Oral ondansetron has been shown to reduce vomiting and the need for intravenous rehydration, as well as reduce the need for hospitalization in children with evidence of dehydration, but has no significant benefits for children who are not dehydrated, the researchers noted.

“Given the high prevalence and costs associated with acute gastroenteritis treatment for children, understanding national trends in management in a broad, generalizable sample is important,” they wrote.

In a study published in JAMA Network Open, the researchers identified data from the National Hospital Ambulatory Medical Care Survey from Jan. 1, 2006, to Dec. 31, 2018. They analyzed ED visits by individuals younger than 18 years with either a primary discharge diagnosis of acute gastroenteritis or a primary diagnosis of nausea, vomiting, diarrhea, or dehydration with a secondary diagnosis of acute gastroenteritis. The study population included 4,122 patients with a mean age of 4.8 years. Approximately 85% of the visits were to nonacademic EDs, and 80% were to nonpediatric EDs.

Overall, ED visits for acute gastroenteritis increased over time, from 1.23 million in 2006 to 1.87 million in 2018 (P = .03 for trend). ED visits for acute gastroenteritis also increased significantly as a proportion of all ED pediatric visits, from 4.7% in 2006 to 5.6% in 2018 (P = .02 for trend).

Notably, the use of ondansetron increased from 10.6% in 2006 to 59.2% in 2018; however, intravenous rehydration and hospitalizations remained consistent over the study period, the researchers wrote. Approximately half of children who received intravenous fluids (53.9%) and those hospitalized (49.1%) also received ondansetron.

“Approximately half of children administered intravenous fluids or hospitalized did not receive ondansetron, suggesting that many children without dehydration receive ondansetron with limited benefit, whereas those most likely to benefit receive intravenous fluids without an adequate trial of ondansetron and oral rehydration therapy,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on detailed patient-level information such as severity of dehydration, the researchers noted. Other limitations include lack of data on return visits and lack of data on the route of medication administration, which means that the perceived lack of benefit from ondansetron may be the result of children treated with both intravenous ondansetron and fluids, they said.

“Ondansetron-supported oral rehydration therapy for appropriately selected children can achieve intravenous rehydration rates of 9%, more than threefold lower than 2018 national estimates,” and more initiatives are needed to optimize ondansetron and reduce the excessive use of intravenous fluids, the researchers concluded.
 

Emergency care setting may promote IV fluid use

“Acute gastroenteritis has remained a major cause of pediatric morbidity and mortality worldwide with significant costs for the health care system,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice who was not involved in the current study, said in an interview. “The authors highlight that although ondansetron use for acute gastroenteritis in the ED has increased substantially, there are still a number of children who receive intravenous fluids in the ED without a trial of ondansetron and [oral rehydration therapy] first. For the individual patient, it is not surprising that the fast-paced culture of the ED doesn’t cater to a watchful waiting approach. This highlights the need for a more protocol-based algorithm for care of these patients upon check-in.

“Often the practice in the ED is a single dose of ondansetron, followed by attempts at oral rehydration 30 minutes later,” said Dr. Joos. “It would be interesting to know the extent that outpatient clinics are practicing this model prior to sending the patient on to the ED. Despite it becoming a common practice, there is still ongoing research into the efficacy and safety of multidose oral ondansetron at home in reducing ED visits/hospitalizations.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose. Lead author Dr. Burstein received a career award from the Quebec Health Research Fund.

Use of oral ondansetron for acute gastroenteritis in children in an emergency setting increased significantly between 2006 and 2018, but use of intravenous fluids remained consistent, based on data from a cross-sectional analysis.

Recommendations for managing acute gastroenteritis in children include oral rehydration therapy for mild to moderate cases and intravenous rehydration for severe cases, Brett Burstein, MDCM, of McGill University, Montreal, and colleagues wrote.

Oral ondansetron has been shown to reduce vomiting and the need for intravenous rehydration, as well as reduce the need for hospitalization in children with evidence of dehydration, but has no significant benefits for children who are not dehydrated, the researchers noted.

“Given the high prevalence and costs associated with acute gastroenteritis treatment for children, understanding national trends in management in a broad, generalizable sample is important,” they wrote.

In a study published in JAMA Network Open, the researchers identified data from the National Hospital Ambulatory Medical Care Survey from Jan. 1, 2006, to Dec. 31, 2018. They analyzed ED visits by individuals younger than 18 years with either a primary discharge diagnosis of acute gastroenteritis or a primary diagnosis of nausea, vomiting, diarrhea, or dehydration with a secondary diagnosis of acute gastroenteritis. The study population included 4,122 patients with a mean age of 4.8 years. Approximately 85% of the visits were to nonacademic EDs, and 80% were to nonpediatric EDs.

Overall, ED visits for acute gastroenteritis increased over time, from 1.23 million in 2006 to 1.87 million in 2018 (P = .03 for trend). ED visits for acute gastroenteritis also increased significantly as a proportion of all ED pediatric visits, from 4.7% in 2006 to 5.6% in 2018 (P = .02 for trend).

Notably, the use of ondansetron increased from 10.6% in 2006 to 59.2% in 2018; however, intravenous rehydration and hospitalizations remained consistent over the study period, the researchers wrote. Approximately half of children who received intravenous fluids (53.9%) and those hospitalized (49.1%) also received ondansetron.

“Approximately half of children administered intravenous fluids or hospitalized did not receive ondansetron, suggesting that many children without dehydration receive ondansetron with limited benefit, whereas those most likely to benefit receive intravenous fluids without an adequate trial of ondansetron and oral rehydration therapy,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on detailed patient-level information such as severity of dehydration, the researchers noted. Other limitations include lack of data on return visits and lack of data on the route of medication administration, which means that the perceived lack of benefit from ondansetron may be the result of children treated with both intravenous ondansetron and fluids, they said.

“Ondansetron-supported oral rehydration therapy for appropriately selected children can achieve intravenous rehydration rates of 9%, more than threefold lower than 2018 national estimates,” and more initiatives are needed to optimize ondansetron and reduce the excessive use of intravenous fluids, the researchers concluded.
 

Emergency care setting may promote IV fluid use

“Acute gastroenteritis has remained a major cause of pediatric morbidity and mortality worldwide with significant costs for the health care system,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice who was not involved in the current study, said in an interview. “The authors highlight that although ondansetron use for acute gastroenteritis in the ED has increased substantially, there are still a number of children who receive intravenous fluids in the ED without a trial of ondansetron and [oral rehydration therapy] first. For the individual patient, it is not surprising that the fast-paced culture of the ED doesn’t cater to a watchful waiting approach. This highlights the need for a more protocol-based algorithm for care of these patients upon check-in.

“Often the practice in the ED is a single dose of ondansetron, followed by attempts at oral rehydration 30 minutes later,” said Dr. Joos. “It would be interesting to know the extent that outpatient clinics are practicing this model prior to sending the patient on to the ED. Despite it becoming a common practice, there is still ongoing research into the efficacy and safety of multidose oral ondansetron at home in reducing ED visits/hospitalizations.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose. Lead author Dr. Burstein received a career award from the Quebec Health Research Fund.

Use of oral ondansetron for acute gastroenteritis in children in an emergency setting increased significantly between 2006 and 2018, but use of intravenous fluids remained consistent, based on data from a cross-sectional analysis.

Recommendations for managing acute gastroenteritis in children include oral rehydration therapy for mild to moderate cases and intravenous rehydration for severe cases, Brett Burstein, MDCM, of McGill University, Montreal, and colleagues wrote.

Oral ondansetron has been shown to reduce vomiting and the need for intravenous rehydration, as well as reduce the need for hospitalization in children with evidence of dehydration, but has no significant benefits for children who are not dehydrated, the researchers noted.

“Given the high prevalence and costs associated with acute gastroenteritis treatment for children, understanding national trends in management in a broad, generalizable sample is important,” they wrote.

In a study published in JAMA Network Open, the researchers identified data from the National Hospital Ambulatory Medical Care Survey from Jan. 1, 2006, to Dec. 31, 2018. They analyzed ED visits by individuals younger than 18 years with either a primary discharge diagnosis of acute gastroenteritis or a primary diagnosis of nausea, vomiting, diarrhea, or dehydration with a secondary diagnosis of acute gastroenteritis. The study population included 4,122 patients with a mean age of 4.8 years. Approximately 85% of the visits were to nonacademic EDs, and 80% were to nonpediatric EDs.

Overall, ED visits for acute gastroenteritis increased over time, from 1.23 million in 2006 to 1.87 million in 2018 (P = .03 for trend). ED visits for acute gastroenteritis also increased significantly as a proportion of all ED pediatric visits, from 4.7% in 2006 to 5.6% in 2018 (P = .02 for trend).

Notably, the use of ondansetron increased from 10.6% in 2006 to 59.2% in 2018; however, intravenous rehydration and hospitalizations remained consistent over the study period, the researchers wrote. Approximately half of children who received intravenous fluids (53.9%) and those hospitalized (49.1%) also received ondansetron.

“Approximately half of children administered intravenous fluids or hospitalized did not receive ondansetron, suggesting that many children without dehydration receive ondansetron with limited benefit, whereas those most likely to benefit receive intravenous fluids without an adequate trial of ondansetron and oral rehydration therapy,” the researchers wrote in their discussion of the findings.

The study findings were limited by several factors including the lack of data on detailed patient-level information such as severity of dehydration, the researchers noted. Other limitations include lack of data on return visits and lack of data on the route of medication administration, which means that the perceived lack of benefit from ondansetron may be the result of children treated with both intravenous ondansetron and fluids, they said.

“Ondansetron-supported oral rehydration therapy for appropriately selected children can achieve intravenous rehydration rates of 9%, more than threefold lower than 2018 national estimates,” and more initiatives are needed to optimize ondansetron and reduce the excessive use of intravenous fluids, the researchers concluded.
 

Emergency care setting may promote IV fluid use

“Acute gastroenteritis has remained a major cause of pediatric morbidity and mortality worldwide with significant costs for the health care system,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice who was not involved in the current study, said in an interview. “The authors highlight that although ondansetron use for acute gastroenteritis in the ED has increased substantially, there are still a number of children who receive intravenous fluids in the ED without a trial of ondansetron and [oral rehydration therapy] first. For the individual patient, it is not surprising that the fast-paced culture of the ED doesn’t cater to a watchful waiting approach. This highlights the need for a more protocol-based algorithm for care of these patients upon check-in.

“Often the practice in the ED is a single dose of ondansetron, followed by attempts at oral rehydration 30 minutes later,” said Dr. Joos. “It would be interesting to know the extent that outpatient clinics are practicing this model prior to sending the patient on to the ED. Despite it becoming a common practice, there is still ongoing research into the efficacy and safety of multidose oral ondansetron at home in reducing ED visits/hospitalizations.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose. Lead author Dr. Burstein received a career award from the Quebec Health Research Fund.