TBD Meeting (3205-22)

WASHINGTON – The life expectancy of non-Hispanic Black men who have sex with men (MSM) and are infected with HIV lags their White counterparts by 6.3 years under standard HIV care, new data from simulation modeling suggest.

Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.

“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”

Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.

• The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
• Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
• In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.

Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.

The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.

Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
 

Life expectancy gap ‘alarming’

“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”

With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”

Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.

They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.

Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.

“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.

Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.

Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.

Dr. McManus and the study authors have reported no relevant financial relationships.

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

WASHINGTON – The life expectancy of non-Hispanic Black men who have sex with men (MSM) and are infected with HIV lags their White counterparts by 6.3 years under standard HIV care, new data from simulation modeling suggest.

Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.

“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”

Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.

• The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
• Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
• In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.

Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.

The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.

Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
 

Life expectancy gap ‘alarming’

“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”

With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”

Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.

They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.

Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.

“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.

Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.

Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.

Dr. McManus and the study authors have reported no relevant financial relationships.

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

WASHINGTON – The life expectancy of non-Hispanic Black men who have sex with men (MSM) and are infected with HIV lags their White counterparts by 6.3 years under standard HIV care, new data from simulation modeling suggest.

Lead author Katherine Rich, MPH, a student at Harvard Medical School, Boston, presented the data during an annual scientific meeting on infectious diseases.

“Substantial disparities in care exist between Black and White MSM here in the United States,” she said. “The 2030 goals of the EHE [Ending the HIV Epidemic in the U.S. initiative] won’t be met until HIV-related disparities are reduced.”

Using modeling, the team was able to measure both the gaps and the potential of interventions to address those gaps.

• The team found that improving engagement in care had the largest benefit in narrowing the gap. Improving engagement and retention in care, they write, would result in a gain of 1.4 life-years for Black MSM and 1 year for White MSM.
• Annual testing would add 0.6 life-years for Black MSM and 0.3 life-years for White MSM, compared with standard care.
• In simulating viral suppression, the model-predicted gain would be 1.1 years for Black MSM and 0.3 for White.

Furthermore, a combination of annual testing, 95% engagement in care, and 95% virologic suppression would add 3.4 years for Black MSM (more than double the increase in life-years for any one intervention) and 1.6 years for their White counterparts, the research suggests.

The researchers projected life expectancy from age 15 to be 52.2 years for Black MSM (or 67.2 years old) and 58.5 years from age 15 for White MSM (or 73.5 years old), a difference of 6.3 years.

Kathleen McManus, MD, assistant professor of medicine in infectious diseases and international health at the University of Virginia, Charlottesville, said in an interview that the projected gap in years of life should be a call to action. Dr. McManus was not involved with the study.
 

Life expectancy gap ‘alarming’

“It is alarming that with current usual HIV care Black MSM with HIV have 6.3 fewer years of life expectancy than White MSM,” she said. “Black MSM having lower retention in care and a lower rate of viral suppression than White MSM demonstrates that there is a problem with our current health care delivery to Black MSM.”

With qualitative, community-engaged research, she said, “we need to ask the Black MSM community what care innovations they need – and then we need clinics and organizations to make the identified changes.”

Researchers used the validated CEPAC (Cost-Effectiveness of Preventing AIDS Complications) microsimulation HIV model to project life expectancy. Using data from the United States Centers for Disease Control and Prevention, they estimated the average age at HIV infection to be 26.8 years for Black MSM and 35 years for White MSM.

They estimated the proportion of time that MSM with diagnosed HIV are retained in care to be 75.2% for Black MSM and 80.6% for White MSM. They calculated the proportion who achieve virologic suppression to be 82% for Black MSM and 91.2% for White MSM.

Senior author Emily P. Hyle, MD, associate professor of medicine at Harvard and infectious diseases physician at Massachusetts General Hospital, both in Boston, said in a press conference before the presentation that strategies to narrow the gap will look different by region.

“Our study highlights that if you can find effective interventions, the effect can be incredibly large. These are very large differences in life-years and life expectancies,” she said.

Ms. Rich gave an example of promising interventions by pointing to work by study coauthor Aima Ahonkhai, MD, MPH, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., who has received federal funding to pursue research on whether preventive care outreach in barbershops can improve prevention for Black men with HIV.

Ms. Rich noted that the modeling has limitations in that it focused on health outcomes and did not simulate transmissions. Results also reflect national data and not local HIV care continuums, which, she acknowledged, differ substantially.

Dr. McManus and the study authors have reported no relevant financial relationships.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

Three months after the World Health Organization declared monkeypox a public health emergency, clinical presentations and vaccination strategies are evolving.

New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.

Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.

Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.

Shift away from White men

Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.

“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.

In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.

“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.

No sustained spread outside MSM

Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.

However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.

“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”

She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.

“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.

Severe cases among immunocompromised

Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.

Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”

Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.

She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.

Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”

Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.

Differences from past epidemics

Dr. Titanji said the current outbreak has some differences from historic outbreaks.

The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.

There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.

The scope of suspected cases has also broadened, with changing clinical features.

“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.

Expanding the case definition will help identify who should be tested.

“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”

Vaccine strategy has evolved

Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.

Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”

It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.

Early data from the CDC indicate that the Jynneos vaccine is effective.

In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.

“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.

Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”

Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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