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Sex workers: High rates of HIV, low rates of treatment
The HIV pandemic among sex workers remains underaddressed and underresourced, with “glaring gaps” in comprehensive measures of HIV prevalence and incidence, and in prevention and treatment, according to the results of an updated literature review published in the Lancet.
Kate Shannon, PhD, director of the gender and sexual health initiative at the University of British Columbia, Vancouver, and her colleagues updated a 2013 literature search for the Lancet series on HIV and sex workers to include reports and manuscripts published from Jan. 1, 2006, to Sept. 6, 2017.
They found that In particular, 4 years after their previous Lancet series on HIV and sex workers, this updated analysis showed that the global HIV burden among female sex workers was still similar to the previously determined 11.8% and “unacceptably high” at 10.4%, (95% confidence interval, 9.5-11.5).
Although there has been some improvement in the assessment of HIV in transgender women since the previous analysis, according to Dr. Shannon and her colleagues, small sample sizes and conflation of transgender women and men who have sex with men (MSM) continue to limit the volume of transgender-specific HIV data, particularly in Africa.
Access to HIV prevention and treatment also remains a considerable problem for sex workers, according to the authors. In particular, “qualitative data in sub-Saharan Africa suggest that profound structural barriers of stigma and discrimination impede progress in the HIV care continuum,” with studies confirming that “successful HIV treatment trajectories are impeded by violence and displacement” because of policing, they wrote.
They pointed out that things may well become worse, with evidence-based progress on full decriminalization grounded in health and human rights – which was a key recommendation in their earlier Lancet Series – having stalled in all but South Africa. In fact, they reported that several countries had even rolled back rights further for sex workers.
“HIV prevention and treatment tools are available but, without comprehensive HIV epidemiology, a lack of denominators and failure to address structural determinants (including decriminalisation of sex work) means that progress in achieving health and rights for all sex workers will fall short,” the researchers concluded.
The authors reported that they had no competing interests.
SOURCE: Shannon K et al. Lancet. 2018 Aug 25;392:698-710.
The HIV pandemic among sex workers remains underaddressed and underresourced, with “glaring gaps” in comprehensive measures of HIV prevalence and incidence, and in prevention and treatment, according to the results of an updated literature review published in the Lancet.
Kate Shannon, PhD, director of the gender and sexual health initiative at the University of British Columbia, Vancouver, and her colleagues updated a 2013 literature search for the Lancet series on HIV and sex workers to include reports and manuscripts published from Jan. 1, 2006, to Sept. 6, 2017.
They found that In particular, 4 years after their previous Lancet series on HIV and sex workers, this updated analysis showed that the global HIV burden among female sex workers was still similar to the previously determined 11.8% and “unacceptably high” at 10.4%, (95% confidence interval, 9.5-11.5).
Although there has been some improvement in the assessment of HIV in transgender women since the previous analysis, according to Dr. Shannon and her colleagues, small sample sizes and conflation of transgender women and men who have sex with men (MSM) continue to limit the volume of transgender-specific HIV data, particularly in Africa.
Access to HIV prevention and treatment also remains a considerable problem for sex workers, according to the authors. In particular, “qualitative data in sub-Saharan Africa suggest that profound structural barriers of stigma and discrimination impede progress in the HIV care continuum,” with studies confirming that “successful HIV treatment trajectories are impeded by violence and displacement” because of policing, they wrote.
They pointed out that things may well become worse, with evidence-based progress on full decriminalization grounded in health and human rights – which was a key recommendation in their earlier Lancet Series – having stalled in all but South Africa. In fact, they reported that several countries had even rolled back rights further for sex workers.
“HIV prevention and treatment tools are available but, without comprehensive HIV epidemiology, a lack of denominators and failure to address structural determinants (including decriminalisation of sex work) means that progress in achieving health and rights for all sex workers will fall short,” the researchers concluded.
The authors reported that they had no competing interests.
SOURCE: Shannon K et al. Lancet. 2018 Aug 25;392:698-710.
The HIV pandemic among sex workers remains underaddressed and underresourced, with “glaring gaps” in comprehensive measures of HIV prevalence and incidence, and in prevention and treatment, according to the results of an updated literature review published in the Lancet.
Kate Shannon, PhD, director of the gender and sexual health initiative at the University of British Columbia, Vancouver, and her colleagues updated a 2013 literature search for the Lancet series on HIV and sex workers to include reports and manuscripts published from Jan. 1, 2006, to Sept. 6, 2017.
They found that In particular, 4 years after their previous Lancet series on HIV and sex workers, this updated analysis showed that the global HIV burden among female sex workers was still similar to the previously determined 11.8% and “unacceptably high” at 10.4%, (95% confidence interval, 9.5-11.5).
Although there has been some improvement in the assessment of HIV in transgender women since the previous analysis, according to Dr. Shannon and her colleagues, small sample sizes and conflation of transgender women and men who have sex with men (MSM) continue to limit the volume of transgender-specific HIV data, particularly in Africa.
Access to HIV prevention and treatment also remains a considerable problem for sex workers, according to the authors. In particular, “qualitative data in sub-Saharan Africa suggest that profound structural barriers of stigma and discrimination impede progress in the HIV care continuum,” with studies confirming that “successful HIV treatment trajectories are impeded by violence and displacement” because of policing, they wrote.
They pointed out that things may well become worse, with evidence-based progress on full decriminalization grounded in health and human rights – which was a key recommendation in their earlier Lancet Series – having stalled in all but South Africa. In fact, they reported that several countries had even rolled back rights further for sex workers.
“HIV prevention and treatment tools are available but, without comprehensive HIV epidemiology, a lack of denominators and failure to address structural determinants (including decriminalisation of sex work) means that progress in achieving health and rights for all sex workers will fall short,” the researchers concluded.
The authors reported that they had no competing interests.
SOURCE: Shannon K et al. Lancet. 2018 Aug 25;392:698-710.
FROM THE LANCET
Key clinical point: The HIV pandemic among sex workers remains underaddressed and underresourced, with “glaring gaps” in assessment, treatment.
Major finding: The global HIV burden among female sex workers shows that HIV prevalence was “unacceptably high” at 10.4%.
Study details: Researchers updated a 2013 literature review with reports published from Jan. 1, 2006, to Sept. 6, 2017.
Disclosures: The authors reported that they had no competing interests.
Source: Shannon K et al. Lancet. 2018 Aug 25;392:698-710.
ICU infections: Chlorhexidine wipes tame MRSA, CRE
according to a report presented at ID Week 2018.
The move prevented an estimated eight methicillin-resistant Staphylococcus aureus (MRSA) and three carbapenem-resistant Enterobacteriaceae (CRE) infections and saved the medical center more than $150,000 in the year following the November 2016 switch.
The goal was to address the rate of MRSA bacteremia, which was higher than national ICU averages. Contact precautions began to make less sense as MRSA became more common in the surrounding community, and “we just wanted to get rid of contact precautions,” said study lead Jason Moss, DO, an infectious disease fellow at the university.
Contact precautions are expensive, make patients feel isolated, and according to some studies, lead to worse outcomes, he said at the annual scientific meeting on infectious diseases.
Decolonization is not routine in most ICUs, but it’s gaining traction. Guidelines recommend chlorhexidine bathing with wipes to stop CRE transmission, and chlorhexidine is used to prevent central line–associated bloodstream infections (CLABSI).
A recent analysis of 17 trials found marked decreases in MRSA and CLABSI with decolonization and concluded that chlorhexidine bathing “appears to be of the most clinical benefit when infection rates are high for a given ICU population,” as was the case in Kentucky (Crit Care. 2016 Nov 23;20[1]:379).
When researchers compared the year before the change to the year after, “we were pretty surprised at how much the rates of infection and colonization decreased. There have been some people that have been doing this in the ICU, but probably not to our extent. If you want to get rid of contact precautions, this is a great process to do it with,” Dr. Moss said.
Rates of colonization with MRSA or CRE fell from about 14 isolates per 10,000 patient-days to fewer than 6 (P = .026). Infection rates fell from 3.9 isolates per 10,000 patient-days to 2 (P = .083). Combined rates of infections and colonizations fell from almost 18 isolates per 10,000 patient-days to fewer than 8 (P = .010).
Decolonization is now standard practice at the university. Every ICU patient gets a one-time povidone iodine nasal swab at admission, then daily baths with 2% chlorhexidine gluconate applied by impregnated wipe. It usually takes four or five wipes to do the entire body.
Spending on gowns fell from about $153,000 per year to just under $60,000, but spending on wipes went up from about $2,700 to $275,000, and spending on povidone iodine nasal swabs went up to more than $100,000.
When balanced against the money not spent on those 11 prevented infections, however, the program saved the medical center about $152,000 in its first year, according to Dr. Moss and his team.
There was no funding for the work, and the investigators had no disclosures.
SOURCE: Moss J et al. ID Week 2018, Abstract 32.
according to a report presented at ID Week 2018.
The move prevented an estimated eight methicillin-resistant Staphylococcus aureus (MRSA) and three carbapenem-resistant Enterobacteriaceae (CRE) infections and saved the medical center more than $150,000 in the year following the November 2016 switch.
The goal was to address the rate of MRSA bacteremia, which was higher than national ICU averages. Contact precautions began to make less sense as MRSA became more common in the surrounding community, and “we just wanted to get rid of contact precautions,” said study lead Jason Moss, DO, an infectious disease fellow at the university.
Contact precautions are expensive, make patients feel isolated, and according to some studies, lead to worse outcomes, he said at the annual scientific meeting on infectious diseases.
Decolonization is not routine in most ICUs, but it’s gaining traction. Guidelines recommend chlorhexidine bathing with wipes to stop CRE transmission, and chlorhexidine is used to prevent central line–associated bloodstream infections (CLABSI).
A recent analysis of 17 trials found marked decreases in MRSA and CLABSI with decolonization and concluded that chlorhexidine bathing “appears to be of the most clinical benefit when infection rates are high for a given ICU population,” as was the case in Kentucky (Crit Care. 2016 Nov 23;20[1]:379).
When researchers compared the year before the change to the year after, “we were pretty surprised at how much the rates of infection and colonization decreased. There have been some people that have been doing this in the ICU, but probably not to our extent. If you want to get rid of contact precautions, this is a great process to do it with,” Dr. Moss said.
Rates of colonization with MRSA or CRE fell from about 14 isolates per 10,000 patient-days to fewer than 6 (P = .026). Infection rates fell from 3.9 isolates per 10,000 patient-days to 2 (P = .083). Combined rates of infections and colonizations fell from almost 18 isolates per 10,000 patient-days to fewer than 8 (P = .010).
Decolonization is now standard practice at the university. Every ICU patient gets a one-time povidone iodine nasal swab at admission, then daily baths with 2% chlorhexidine gluconate applied by impregnated wipe. It usually takes four or five wipes to do the entire body.
Spending on gowns fell from about $153,000 per year to just under $60,000, but spending on wipes went up from about $2,700 to $275,000, and spending on povidone iodine nasal swabs went up to more than $100,000.
When balanced against the money not spent on those 11 prevented infections, however, the program saved the medical center about $152,000 in its first year, according to Dr. Moss and his team.
There was no funding for the work, and the investigators had no disclosures.
SOURCE: Moss J et al. ID Week 2018, Abstract 32.
according to a report presented at ID Week 2018.
The move prevented an estimated eight methicillin-resistant Staphylococcus aureus (MRSA) and three carbapenem-resistant Enterobacteriaceae (CRE) infections and saved the medical center more than $150,000 in the year following the November 2016 switch.
The goal was to address the rate of MRSA bacteremia, which was higher than national ICU averages. Contact precautions began to make less sense as MRSA became more common in the surrounding community, and “we just wanted to get rid of contact precautions,” said study lead Jason Moss, DO, an infectious disease fellow at the university.
Contact precautions are expensive, make patients feel isolated, and according to some studies, lead to worse outcomes, he said at the annual scientific meeting on infectious diseases.
Decolonization is not routine in most ICUs, but it’s gaining traction. Guidelines recommend chlorhexidine bathing with wipes to stop CRE transmission, and chlorhexidine is used to prevent central line–associated bloodstream infections (CLABSI).
A recent analysis of 17 trials found marked decreases in MRSA and CLABSI with decolonization and concluded that chlorhexidine bathing “appears to be of the most clinical benefit when infection rates are high for a given ICU population,” as was the case in Kentucky (Crit Care. 2016 Nov 23;20[1]:379).
When researchers compared the year before the change to the year after, “we were pretty surprised at how much the rates of infection and colonization decreased. There have been some people that have been doing this in the ICU, but probably not to our extent. If you want to get rid of contact precautions, this is a great process to do it with,” Dr. Moss said.
Rates of colonization with MRSA or CRE fell from about 14 isolates per 10,000 patient-days to fewer than 6 (P = .026). Infection rates fell from 3.9 isolates per 10,000 patient-days to 2 (P = .083). Combined rates of infections and colonizations fell from almost 18 isolates per 10,000 patient-days to fewer than 8 (P = .010).
Decolonization is now standard practice at the university. Every ICU patient gets a one-time povidone iodine nasal swab at admission, then daily baths with 2% chlorhexidine gluconate applied by impregnated wipe. It usually takes four or five wipes to do the entire body.
Spending on gowns fell from about $153,000 per year to just under $60,000, but spending on wipes went up from about $2,700 to $275,000, and spending on povidone iodine nasal swabs went up to more than $100,000.
When balanced against the money not spent on those 11 prevented infections, however, the program saved the medical center about $152,000 in its first year, according to Dr. Moss and his team.
There was no funding for the work, and the investigators had no disclosures.
SOURCE: Moss J et al. ID Week 2018, Abstract 32.
REPORTING FROM ID WEEK 2018
Key clinical point: For high rates of MRSA and CRE in the ICU, consider decolonization instead of contact precautions.
Major finding: Rates of colonization with MRSA or CRE fell from about 14 isolates per 10,000 patient-days to fewer than 6; infection rates fell from 3.9 isolates to 2 per 10,000 patient-days.
Study details: Review of ICU quality improvement initiative
Disclosures: There was no funding for the work, and the investigators had no disclosures.
Source: Moss J et al. ID Week 2018, Abstract 32.
Automated algorithm improves HIV/HCV screening in the ED
More patients had newly diagnosed HIV and hepatitis C virus (HCV) infection during an automated-laboratory-order HIV/HCV screening algorithm than with a nurse-order HIV/HCV screening algorithm, according to the results of a retrospective before/after comparison study of the two electronic health record (EHR)–based protocols.
The results of nurse-order HIV/HCV screening in the 5-month period of March 1, 2016, through July 31, 2016, were compared to the subsequently adopted automated-laboratory-order system results from March 1, 2017, through July 31, 2017, according to Douglas A.E. White, MD, and his colleagues at Highland Hospital Emergency Department, Oakland, Calif.
Via the EHR, nurses were instructed to offer screening to all adults aged 18-75 years unless they were known to be HIV- or HCV-positive, unable to verbally consent (e.g., language barriers, intoxication), or medically unstable. Exclusion was at the discretion of the triage nurse. Using a drop-down menu, nurses could choose “accepts” or “declines” for HIV and HCV testing, according to patient response. Choosing “accepts” automatically ordered the test, according to the report (Ann Emerg Med. 2018 Oct;72[4]:438-48).
Automated-laboratory-order HIV/HCV screening was integrated into clinical care. With this protocol, the EHR-automated annual HIV/hepatitis C virus screening was performed on adult patients aged 18-75 years who had laboratory tests ordered. The EHR was configured to automatically order an HIV or HCV test for age-eligible patients who had any test ordered that required laboratory processing of whole blood (excluding point-of-care tests such as for lactate or glucose level) or a urine or urethral swab for chlamydia or gonorrhea testing, according to the researchers.
There were 20,975 and 19,887 unique, age-eligible patients during the nurse-order HIV/HCV virus screening algorithm and automated-laboratory-order HIV/HCV screening algorithm study periods, respectively. A total of 4,121 patients (19.6%) were screened for HIV and 2,968 (14.2%) patients were screened for HCV during the nurse-order period vs. 6,736 (33.9%) patients screened for HIV and 6,972 (35.1%) screened for HCV during the automated-laboratory-order period.
Overall, HIV screening increased from 19.6% to 33.9% and HCV screening, from 14.2% to 35.1% using the automated vs. the nurse-ordered EHR-based algorithm.
“An automated electronic health record algorithm that links nontargeted opt-out HIV and hepatitis C virus screening to physician laboratory ordering more effectively screens ED patients, provides results before discharge, minimizes repeated screening, and diagnoses more new infections than an algorithm that relies on nursing staff to offer screening. Because most EDs in the United States now use EHR systems, this model can be easily replicated and should be considered the standard for future programs,” the researchers concluded.
This work was supported, in part, by grant funding through the FOCUS program, Gilead Sciences, which also has provided funding to various of the authors of the study.
SOURCE: White DAE et al. Ann Emerg Med. 2018 Oct;72[4]:438-48.
More patients had newly diagnosed HIV and hepatitis C virus (HCV) infection during an automated-laboratory-order HIV/HCV screening algorithm than with a nurse-order HIV/HCV screening algorithm, according to the results of a retrospective before/after comparison study of the two electronic health record (EHR)–based protocols.
The results of nurse-order HIV/HCV screening in the 5-month period of March 1, 2016, through July 31, 2016, were compared to the subsequently adopted automated-laboratory-order system results from March 1, 2017, through July 31, 2017, according to Douglas A.E. White, MD, and his colleagues at Highland Hospital Emergency Department, Oakland, Calif.
Via the EHR, nurses were instructed to offer screening to all adults aged 18-75 years unless they were known to be HIV- or HCV-positive, unable to verbally consent (e.g., language barriers, intoxication), or medically unstable. Exclusion was at the discretion of the triage nurse. Using a drop-down menu, nurses could choose “accepts” or “declines” for HIV and HCV testing, according to patient response. Choosing “accepts” automatically ordered the test, according to the report (Ann Emerg Med. 2018 Oct;72[4]:438-48).
Automated-laboratory-order HIV/HCV screening was integrated into clinical care. With this protocol, the EHR-automated annual HIV/hepatitis C virus screening was performed on adult patients aged 18-75 years who had laboratory tests ordered. The EHR was configured to automatically order an HIV or HCV test for age-eligible patients who had any test ordered that required laboratory processing of whole blood (excluding point-of-care tests such as for lactate or glucose level) or a urine or urethral swab for chlamydia or gonorrhea testing, according to the researchers.
There were 20,975 and 19,887 unique, age-eligible patients during the nurse-order HIV/HCV virus screening algorithm and automated-laboratory-order HIV/HCV screening algorithm study periods, respectively. A total of 4,121 patients (19.6%) were screened for HIV and 2,968 (14.2%) patients were screened for HCV during the nurse-order period vs. 6,736 (33.9%) patients screened for HIV and 6,972 (35.1%) screened for HCV during the automated-laboratory-order period.
Overall, HIV screening increased from 19.6% to 33.9% and HCV screening, from 14.2% to 35.1% using the automated vs. the nurse-ordered EHR-based algorithm.
“An automated electronic health record algorithm that links nontargeted opt-out HIV and hepatitis C virus screening to physician laboratory ordering more effectively screens ED patients, provides results before discharge, minimizes repeated screening, and diagnoses more new infections than an algorithm that relies on nursing staff to offer screening. Because most EDs in the United States now use EHR systems, this model can be easily replicated and should be considered the standard for future programs,” the researchers concluded.
This work was supported, in part, by grant funding through the FOCUS program, Gilead Sciences, which also has provided funding to various of the authors of the study.
SOURCE: White DAE et al. Ann Emerg Med. 2018 Oct;72[4]:438-48.
More patients had newly diagnosed HIV and hepatitis C virus (HCV) infection during an automated-laboratory-order HIV/HCV screening algorithm than with a nurse-order HIV/HCV screening algorithm, according to the results of a retrospective before/after comparison study of the two electronic health record (EHR)–based protocols.
The results of nurse-order HIV/HCV screening in the 5-month period of March 1, 2016, through July 31, 2016, were compared to the subsequently adopted automated-laboratory-order system results from March 1, 2017, through July 31, 2017, according to Douglas A.E. White, MD, and his colleagues at Highland Hospital Emergency Department, Oakland, Calif.
Via the EHR, nurses were instructed to offer screening to all adults aged 18-75 years unless they were known to be HIV- or HCV-positive, unable to verbally consent (e.g., language barriers, intoxication), or medically unstable. Exclusion was at the discretion of the triage nurse. Using a drop-down menu, nurses could choose “accepts” or “declines” for HIV and HCV testing, according to patient response. Choosing “accepts” automatically ordered the test, according to the report (Ann Emerg Med. 2018 Oct;72[4]:438-48).
Automated-laboratory-order HIV/HCV screening was integrated into clinical care. With this protocol, the EHR-automated annual HIV/hepatitis C virus screening was performed on adult patients aged 18-75 years who had laboratory tests ordered. The EHR was configured to automatically order an HIV or HCV test for age-eligible patients who had any test ordered that required laboratory processing of whole blood (excluding point-of-care tests such as for lactate or glucose level) or a urine or urethral swab for chlamydia or gonorrhea testing, according to the researchers.
There were 20,975 and 19,887 unique, age-eligible patients during the nurse-order HIV/HCV virus screening algorithm and automated-laboratory-order HIV/HCV screening algorithm study periods, respectively. A total of 4,121 patients (19.6%) were screened for HIV and 2,968 (14.2%) patients were screened for HCV during the nurse-order period vs. 6,736 (33.9%) patients screened for HIV and 6,972 (35.1%) screened for HCV during the automated-laboratory-order period.
Overall, HIV screening increased from 19.6% to 33.9% and HCV screening, from 14.2% to 35.1% using the automated vs. the nurse-ordered EHR-based algorithm.
“An automated electronic health record algorithm that links nontargeted opt-out HIV and hepatitis C virus screening to physician laboratory ordering more effectively screens ED patients, provides results before discharge, minimizes repeated screening, and diagnoses more new infections than an algorithm that relies on nursing staff to offer screening. Because most EDs in the United States now use EHR systems, this model can be easily replicated and should be considered the standard for future programs,” the researchers concluded.
This work was supported, in part, by grant funding through the FOCUS program, Gilead Sciences, which also has provided funding to various of the authors of the study.
SOURCE: White DAE et al. Ann Emerg Med. 2018 Oct;72[4]:438-48.
FROM ANNALS OF EMERGENCY MEDICINE
Key clinical point:
Major finding: HIV screening increased from 19.6% to 33.9%; HCV screening, from 14.2% to 35.1%, with use of an automated vs. nurse-ordered EHR-based algorithm.
Study details: There were 20,975 and 19,887eligible patients assessed during the nurse-order HIV/HCV screening and the automated–laboratory-order screening periods, respectively.
Disclosures: This work was supported, in part, by grant funding through the FOCUS program, Gilead Sciences, which also has provided funding to various of the authors of the study.
Source: White DAE et al. Ann Emerg Med. 2018 Oct;72[4]:438-48.
Adjuvanted flu vaccine reduces hospitalizations in oldest old
SAN FRANCISCO – presented at an annual scientific meeting on infectious diseases.
“It’s one thing to say you have a more immunogenic vaccine, it’s another thing to be able to say it offers clinical benefit, especially in the oldest old and the frailest frail,” says Stefan Gravenstein, MD, professor of medicine and health services, policy and practice at the Brown University School of Public Health, Providence, R.I. Dr. Gravenstein presented a poster outlying a randomized, clinical trial of the Fluad vaccine in nursing homes.
The study randomized the nursing homes so that some facilities would offer Fluad as part of their standard of care. The design helped address the problem of consent. Any clinical trial that requires individual consent would likely exclude many of the frailest patients, leading to an unrepresentative sample. “So if you want to have a generalizable result, you’d like to have it applied to the population the way you would in the real world, so randomizing the nursing homes rather than the people makes a lot of sense,” said Dr. Gravenstein.
Dr. Gravenstein chose to test the vaccine in nursing home residents, hoping to see a signal in a population in which flu complications are more common. “If you can get a difference in a nursing home population, that’s clinically important, that gives you hope that you can see it in all the other populations, too,” he said.
SOURCE: Gravenstein S et al. IDWeek 2018, Abstract 996.
SAN FRANCISCO – presented at an annual scientific meeting on infectious diseases.
“It’s one thing to say you have a more immunogenic vaccine, it’s another thing to be able to say it offers clinical benefit, especially in the oldest old and the frailest frail,” says Stefan Gravenstein, MD, professor of medicine and health services, policy and practice at the Brown University School of Public Health, Providence, R.I. Dr. Gravenstein presented a poster outlying a randomized, clinical trial of the Fluad vaccine in nursing homes.
The study randomized the nursing homes so that some facilities would offer Fluad as part of their standard of care. The design helped address the problem of consent. Any clinical trial that requires individual consent would likely exclude many of the frailest patients, leading to an unrepresentative sample. “So if you want to have a generalizable result, you’d like to have it applied to the population the way you would in the real world, so randomizing the nursing homes rather than the people makes a lot of sense,” said Dr. Gravenstein.
Dr. Gravenstein chose to test the vaccine in nursing home residents, hoping to see a signal in a population in which flu complications are more common. “If you can get a difference in a nursing home population, that’s clinically important, that gives you hope that you can see it in all the other populations, too,” he said.
SOURCE: Gravenstein S et al. IDWeek 2018, Abstract 996.
SAN FRANCISCO – presented at an annual scientific meeting on infectious diseases.
“It’s one thing to say you have a more immunogenic vaccine, it’s another thing to be able to say it offers clinical benefit, especially in the oldest old and the frailest frail,” says Stefan Gravenstein, MD, professor of medicine and health services, policy and practice at the Brown University School of Public Health, Providence, R.I. Dr. Gravenstein presented a poster outlying a randomized, clinical trial of the Fluad vaccine in nursing homes.
The study randomized the nursing homes so that some facilities would offer Fluad as part of their standard of care. The design helped address the problem of consent. Any clinical trial that requires individual consent would likely exclude many of the frailest patients, leading to an unrepresentative sample. “So if you want to have a generalizable result, you’d like to have it applied to the population the way you would in the real world, so randomizing the nursing homes rather than the people makes a lot of sense,” said Dr. Gravenstein.
Dr. Gravenstein chose to test the vaccine in nursing home residents, hoping to see a signal in a population in which flu complications are more common. “If you can get a difference in a nursing home population, that’s clinically important, that gives you hope that you can see it in all the other populations, too,” he said.
SOURCE: Gravenstein S et al. IDWeek 2018, Abstract 996.
REPORTING FROM ID WEEK 2018
Vancomycin loading boost yields better C. diff outcomes
SAN FRANCISCO – A heightened loading dose of vancomycin may lead to faster recovery and greater efficacy in Clostridium difficile infections, according to the results of a quasi-experimental study presented at an annual scientific meeting on infectious diseases.
The study looked at a loading dose of 500 mg of vancomycin delivered four times per day for the first 48 hours, followed by a step down to 125 mg every 6 hours. It came on the heels of an attempted randomized, clinical trial that was inconclusive because of insufficient recruitment. Still, the results were promising enough to convince the Yale New Haven Hospital to make it standard practice in C. difficile patients.
Samad Tirmizi, PharmD, an infectious disease pharmacist at Stony Brook University (N.Y.), shares the results of a comparison of outcomes before and after the initiation of this treatment protocol in a video interview.
The approach grew out of concerns that vancomycin may not achieve sufficient concentrations in the colon early in treatment. A pharmacokinetics study published in 2010 suggested that a high initial loading led to higher fecal vancomycin levels, even in patients with increased stool frequency (BMC Infect Dis. 2010 Dec 30;10:363).
SOURCE: Tirmizi S et al. IDWeek 2018, Abstract 1980.
SAN FRANCISCO – A heightened loading dose of vancomycin may lead to faster recovery and greater efficacy in Clostridium difficile infections, according to the results of a quasi-experimental study presented at an annual scientific meeting on infectious diseases.
The study looked at a loading dose of 500 mg of vancomycin delivered four times per day for the first 48 hours, followed by a step down to 125 mg every 6 hours. It came on the heels of an attempted randomized, clinical trial that was inconclusive because of insufficient recruitment. Still, the results were promising enough to convince the Yale New Haven Hospital to make it standard practice in C. difficile patients.
Samad Tirmizi, PharmD, an infectious disease pharmacist at Stony Brook University (N.Y.), shares the results of a comparison of outcomes before and after the initiation of this treatment protocol in a video interview.
The approach grew out of concerns that vancomycin may not achieve sufficient concentrations in the colon early in treatment. A pharmacokinetics study published in 2010 suggested that a high initial loading led to higher fecal vancomycin levels, even in patients with increased stool frequency (BMC Infect Dis. 2010 Dec 30;10:363).
SOURCE: Tirmizi S et al. IDWeek 2018, Abstract 1980.
SAN FRANCISCO – A heightened loading dose of vancomycin may lead to faster recovery and greater efficacy in Clostridium difficile infections, according to the results of a quasi-experimental study presented at an annual scientific meeting on infectious diseases.
The study looked at a loading dose of 500 mg of vancomycin delivered four times per day for the first 48 hours, followed by a step down to 125 mg every 6 hours. It came on the heels of an attempted randomized, clinical trial that was inconclusive because of insufficient recruitment. Still, the results were promising enough to convince the Yale New Haven Hospital to make it standard practice in C. difficile patients.
Samad Tirmizi, PharmD, an infectious disease pharmacist at Stony Brook University (N.Y.), shares the results of a comparison of outcomes before and after the initiation of this treatment protocol in a video interview.
The approach grew out of concerns that vancomycin may not achieve sufficient concentrations in the colon early in treatment. A pharmacokinetics study published in 2010 suggested that a high initial loading led to higher fecal vancomycin levels, even in patients with increased stool frequency (BMC Infect Dis. 2010 Dec 30;10:363).
SOURCE: Tirmizi S et al. IDWeek 2018, Abstract 1980.
REPORTING FROM IDWEEK 2018
Myeloperoxidase elevated in HCV-related liver cancer
Myeloperoxidase (MPO) expression was significantly higher in hepatitis C virus (HCV)–related hepatocellular carcinoma (HCC) cases when compared with cirrhotic patients, according to a study of 59 patients with HCV-related liver disease.
HCV is the main cause of liver disease, wrote Mohamed Abdel-Hamed, MD, of Minia University in Egypt, and his colleagues. In addition, HCV is associated with significant oxidative stress, which has been identified as a significant metabolic pathway culminating in hepatic cirrhosis, liver failure, and liver cancer. Thus the researchers studied the role of MPO, an oxidative enzyme released at sites of inflammation, in the possible etiology of HCV-related liver cancer.
The patients were divided into two groups, 25 with HCC and 34 with chronic liver diseases with cirrhosis. All patients were examined immunohistochemically to demonstrate the expression of myeloperoxidase, according to the report published in Meta Gene.
Subjects with HCC showed markedly increased MPO expression when compared with MPO expression in hepatocytes of subjects with liver cirrhosis, who mostly showed a mild degree of expression. In addition, no mild expression of MPO was detected in the subjects with HCC. These findings were highly statistically significant (P less than .0001), according to Dr. Abdel-Hamed and his colleagues.
“The present study showed that marked expression of MPO plays an important role in the pathogenesis of HCV-associated HCC,” the authors stated. “This study could provide valuable, predictive parameters that can be used clinically in the prognosis of HCC patients.”
The authors did not report any disclosures.
SOURCE: Abdel-Hamid M et al. Meta Gene. 2018 Dec;18:1-8.
Myeloperoxidase (MPO) expression was significantly higher in hepatitis C virus (HCV)–related hepatocellular carcinoma (HCC) cases when compared with cirrhotic patients, according to a study of 59 patients with HCV-related liver disease.
HCV is the main cause of liver disease, wrote Mohamed Abdel-Hamed, MD, of Minia University in Egypt, and his colleagues. In addition, HCV is associated with significant oxidative stress, which has been identified as a significant metabolic pathway culminating in hepatic cirrhosis, liver failure, and liver cancer. Thus the researchers studied the role of MPO, an oxidative enzyme released at sites of inflammation, in the possible etiology of HCV-related liver cancer.
The patients were divided into two groups, 25 with HCC and 34 with chronic liver diseases with cirrhosis. All patients were examined immunohistochemically to demonstrate the expression of myeloperoxidase, according to the report published in Meta Gene.
Subjects with HCC showed markedly increased MPO expression when compared with MPO expression in hepatocytes of subjects with liver cirrhosis, who mostly showed a mild degree of expression. In addition, no mild expression of MPO was detected in the subjects with HCC. These findings were highly statistically significant (P less than .0001), according to Dr. Abdel-Hamed and his colleagues.
“The present study showed that marked expression of MPO plays an important role in the pathogenesis of HCV-associated HCC,” the authors stated. “This study could provide valuable, predictive parameters that can be used clinically in the prognosis of HCC patients.”
The authors did not report any disclosures.
SOURCE: Abdel-Hamid M et al. Meta Gene. 2018 Dec;18:1-8.
Myeloperoxidase (MPO) expression was significantly higher in hepatitis C virus (HCV)–related hepatocellular carcinoma (HCC) cases when compared with cirrhotic patients, according to a study of 59 patients with HCV-related liver disease.
HCV is the main cause of liver disease, wrote Mohamed Abdel-Hamed, MD, of Minia University in Egypt, and his colleagues. In addition, HCV is associated with significant oxidative stress, which has been identified as a significant metabolic pathway culminating in hepatic cirrhosis, liver failure, and liver cancer. Thus the researchers studied the role of MPO, an oxidative enzyme released at sites of inflammation, in the possible etiology of HCV-related liver cancer.
The patients were divided into two groups, 25 with HCC and 34 with chronic liver diseases with cirrhosis. All patients were examined immunohistochemically to demonstrate the expression of myeloperoxidase, according to the report published in Meta Gene.
Subjects with HCC showed markedly increased MPO expression when compared with MPO expression in hepatocytes of subjects with liver cirrhosis, who mostly showed a mild degree of expression. In addition, no mild expression of MPO was detected in the subjects with HCC. These findings were highly statistically significant (P less than .0001), according to Dr. Abdel-Hamed and his colleagues.
“The present study showed that marked expression of MPO plays an important role in the pathogenesis of HCV-associated HCC,” the authors stated. “This study could provide valuable, predictive parameters that can be used clinically in the prognosis of HCC patients.”
The authors did not report any disclosures.
SOURCE: Abdel-Hamid M et al. Meta Gene. 2018 Dec;18:1-8.
FROM META GENE
Key clinical point:
Major finding: Hepatocellular carcinoma subjects showed a marked increase of myeloperoxidase expression when compared with subjects with liver cirrhosis (P less than .0001).
Study details: An immunohistochemical analysis of 59 patients infected with hepatitis C virus.
Disclosures: The authors did not report any disclosures.
Source: Abdel-Hamid M et al. Meta Gene. 2018 Dec;18:1-8.
Oral flu vaccine protects, evokes mucosal immunity
SAN FRANCISCO – In a phase II study, Vaxart’s oral flu vaccine was compared with a commercial injectable quadrivalent flu vaccine or placebo. The study found rates of illness were comparable between the oral vaccine and quadrivalent vaccinated groups.*
The recombinant adenovirus-based vaccine expresses hemagglutinin. It elicited a mucosal immune response, hinting that the mechanism of protection in flu vaccines may be dependent on the route of administration. It is also believed that a strong mucosal response is key to preventing future infections.
In an interview at IDWeek 2018, an annual scientific meeting on infectious diseases, Nikita Kolhatkar, PhD, a salaried employee of Vaxart, which makes the drug, describes the results of the study and explains the potential advantages of an oral flu vaccine versus a traditional injectable one. The oral formulation is cell-based and so is not vulnerable to the mutation and genetic drift that can occur in egg-based vaccines.
It is also more stable and, of course, less invasive than injectable vaccines, according to Dr. Kolhatkar.
*Correction, 10/9/2018: An earlier vs. of this article did not stress the comparability.
SOURCE: Kolhatkar N. IDWeek 2018. Poster abstract 1947.
SAN FRANCISCO – In a phase II study, Vaxart’s oral flu vaccine was compared with a commercial injectable quadrivalent flu vaccine or placebo. The study found rates of illness were comparable between the oral vaccine and quadrivalent vaccinated groups.*
The recombinant adenovirus-based vaccine expresses hemagglutinin. It elicited a mucosal immune response, hinting that the mechanism of protection in flu vaccines may be dependent on the route of administration. It is also believed that a strong mucosal response is key to preventing future infections.
In an interview at IDWeek 2018, an annual scientific meeting on infectious diseases, Nikita Kolhatkar, PhD, a salaried employee of Vaxart, which makes the drug, describes the results of the study and explains the potential advantages of an oral flu vaccine versus a traditional injectable one. The oral formulation is cell-based and so is not vulnerable to the mutation and genetic drift that can occur in egg-based vaccines.
It is also more stable and, of course, less invasive than injectable vaccines, according to Dr. Kolhatkar.
*Correction, 10/9/2018: An earlier vs. of this article did not stress the comparability.
SOURCE: Kolhatkar N. IDWeek 2018. Poster abstract 1947.
SAN FRANCISCO – In a phase II study, Vaxart’s oral flu vaccine was compared with a commercial injectable quadrivalent flu vaccine or placebo. The study found rates of illness were comparable between the oral vaccine and quadrivalent vaccinated groups.*
The recombinant adenovirus-based vaccine expresses hemagglutinin. It elicited a mucosal immune response, hinting that the mechanism of protection in flu vaccines may be dependent on the route of administration. It is also believed that a strong mucosal response is key to preventing future infections.
In an interview at IDWeek 2018, an annual scientific meeting on infectious diseases, Nikita Kolhatkar, PhD, a salaried employee of Vaxart, which makes the drug, describes the results of the study and explains the potential advantages of an oral flu vaccine versus a traditional injectable one. The oral formulation is cell-based and so is not vulnerable to the mutation and genetic drift that can occur in egg-based vaccines.
It is also more stable and, of course, less invasive than injectable vaccines, according to Dr. Kolhatkar.
*Correction, 10/9/2018: An earlier vs. of this article did not stress the comparability.
SOURCE: Kolhatkar N. IDWeek 2018. Poster abstract 1947.
REPORTING FROM IDWEEK 2018
How to vaccinate patients on biologics
SAN FRANCISCO – The new herpes zoster subunit vaccine (Shingrix) is on the short list of essential vaccines for immunocompromised adults, including those on biologics.
Ongoing research is demonstrating efficacy and safety in renal transplants patients, as well as those with hematologic cancer and stem cell transplants, according to Lorry Rubin, MD, director of pediatric infectious diseases at Cohen Children’s Medical Center, Queens, and professor of pediatrics at Hofstra University, Hempstead, N.Y.
Immunocompromised people, including those on biologics, should be immunized against a variety of diseases just like everyone else, but it’s tricky. There’s considerable variability in how biologics affect the immune system and subsequent vaccine potency. Timing is important, and although live vaccines are generally a no-go, there’s one class of biologics with which they’re safe, he said.
In a wide-ranging interview at IDWeek 2018, an annual scientific meeting on infectious diseases, Dr. Rubin shared his advice on immunizing the immunocompromised, including the other vaccines on the short list. He also tackled the common concern that vaccinations might trigger rejection in transplant patients.
He’s well qualified to address the issues: Dr. Rubin was lead author on the 2013 Infectious Diseases Society of America guidelines on vaccinating immunocompromised patients.
SAN FRANCISCO – The new herpes zoster subunit vaccine (Shingrix) is on the short list of essential vaccines for immunocompromised adults, including those on biologics.
Ongoing research is demonstrating efficacy and safety in renal transplants patients, as well as those with hematologic cancer and stem cell transplants, according to Lorry Rubin, MD, director of pediatric infectious diseases at Cohen Children’s Medical Center, Queens, and professor of pediatrics at Hofstra University, Hempstead, N.Y.
Immunocompromised people, including those on biologics, should be immunized against a variety of diseases just like everyone else, but it’s tricky. There’s considerable variability in how biologics affect the immune system and subsequent vaccine potency. Timing is important, and although live vaccines are generally a no-go, there’s one class of biologics with which they’re safe, he said.
In a wide-ranging interview at IDWeek 2018, an annual scientific meeting on infectious diseases, Dr. Rubin shared his advice on immunizing the immunocompromised, including the other vaccines on the short list. He also tackled the common concern that vaccinations might trigger rejection in transplant patients.
He’s well qualified to address the issues: Dr. Rubin was lead author on the 2013 Infectious Diseases Society of America guidelines on vaccinating immunocompromised patients.
SAN FRANCISCO – The new herpes zoster subunit vaccine (Shingrix) is on the short list of essential vaccines for immunocompromised adults, including those on biologics.
Ongoing research is demonstrating efficacy and safety in renal transplants patients, as well as those with hematologic cancer and stem cell transplants, according to Lorry Rubin, MD, director of pediatric infectious diseases at Cohen Children’s Medical Center, Queens, and professor of pediatrics at Hofstra University, Hempstead, N.Y.
Immunocompromised people, including those on biologics, should be immunized against a variety of diseases just like everyone else, but it’s tricky. There’s considerable variability in how biologics affect the immune system and subsequent vaccine potency. Timing is important, and although live vaccines are generally a no-go, there’s one class of biologics with which they’re safe, he said.
In a wide-ranging interview at IDWeek 2018, an annual scientific meeting on infectious diseases, Dr. Rubin shared his advice on immunizing the immunocompromised, including the other vaccines on the short list. He also tackled the common concern that vaccinations might trigger rejection in transplant patients.
He’s well qualified to address the issues: Dr. Rubin was lead author on the 2013 Infectious Diseases Society of America guidelines on vaccinating immunocompromised patients.
REPORTING FROM IDWEEK 2018
DAAs top PEG/RBV for reducing HCV cardiovascular risk
SAN FRANCISCO – , according to a review of over 30,000 patients in the ERCHIVES (Electronically Retrieved Cohort of HCV Infected Veterans) database of the Veterans Health Administration system.
In the study, 12,667 patients were treated with direct-acting antiretrovirals (DAAs) and 4,436 with pegylated interferon/ribavirin (PEG/RBV). Each subject was matched to an untreated control based on alcohol use, diabetes, and other confounders. Patients with HIV, hepatitis B, or previously diagnosed cardiovascular disease were excluded.
Over a follow-up of about 10 years, there were 2,361 strokes, heart attacks, or other cardiovascular (CV) events among untreated patients, which translated to an incidence of 30.9 events per 1,000 patient years. In the PEG/RBV group, there were 804 events, yielding an incidence of 23.5 per 1,000 patient years. The DAA group fared better, with 435 events and an incident rate of 16.3.
Sustained virologic response also was associated with lower CV risk, and the odds of attaining it were about 25% greater with DAAs vs. PEG/RBV. That might have played a role in the findings, since hepatitis C is known to be associated with CV disease and the virus has been found in atherosclerotic plaques.
Past investigations have been mixed on whether or not hepatitis C virus treatment reduces CV risk, but lead investigator Adeel Ajwad Butt, MD, professor of medicine at Cornell University, New York, said that his study was stronger than what has come before. He explained why, and also why the findings matter, in an interview at ID Week 2018, an annual scientific meeting on infectious diseases.
Most of the subjects were men, about a quarter were black, and the median age at baseline was 58 years.
Dr. Butt disclosed institutional research grants from Merck and Gilead.
SOURCE: Butt AA et al. ID Week 2018 abstract 930.
SAN FRANCISCO – , according to a review of over 30,000 patients in the ERCHIVES (Electronically Retrieved Cohort of HCV Infected Veterans) database of the Veterans Health Administration system.
In the study, 12,667 patients were treated with direct-acting antiretrovirals (DAAs) and 4,436 with pegylated interferon/ribavirin (PEG/RBV). Each subject was matched to an untreated control based on alcohol use, diabetes, and other confounders. Patients with HIV, hepatitis B, or previously diagnosed cardiovascular disease were excluded.
Over a follow-up of about 10 years, there were 2,361 strokes, heart attacks, or other cardiovascular (CV) events among untreated patients, which translated to an incidence of 30.9 events per 1,000 patient years. In the PEG/RBV group, there were 804 events, yielding an incidence of 23.5 per 1,000 patient years. The DAA group fared better, with 435 events and an incident rate of 16.3.
Sustained virologic response also was associated with lower CV risk, and the odds of attaining it were about 25% greater with DAAs vs. PEG/RBV. That might have played a role in the findings, since hepatitis C is known to be associated with CV disease and the virus has been found in atherosclerotic plaques.
Past investigations have been mixed on whether or not hepatitis C virus treatment reduces CV risk, but lead investigator Adeel Ajwad Butt, MD, professor of medicine at Cornell University, New York, said that his study was stronger than what has come before. He explained why, and also why the findings matter, in an interview at ID Week 2018, an annual scientific meeting on infectious diseases.
Most of the subjects were men, about a quarter were black, and the median age at baseline was 58 years.
Dr. Butt disclosed institutional research grants from Merck and Gilead.
SOURCE: Butt AA et al. ID Week 2018 abstract 930.
SAN FRANCISCO – , according to a review of over 30,000 patients in the ERCHIVES (Electronically Retrieved Cohort of HCV Infected Veterans) database of the Veterans Health Administration system.
In the study, 12,667 patients were treated with direct-acting antiretrovirals (DAAs) and 4,436 with pegylated interferon/ribavirin (PEG/RBV). Each subject was matched to an untreated control based on alcohol use, diabetes, and other confounders. Patients with HIV, hepatitis B, or previously diagnosed cardiovascular disease were excluded.
Over a follow-up of about 10 years, there were 2,361 strokes, heart attacks, or other cardiovascular (CV) events among untreated patients, which translated to an incidence of 30.9 events per 1,000 patient years. In the PEG/RBV group, there were 804 events, yielding an incidence of 23.5 per 1,000 patient years. The DAA group fared better, with 435 events and an incident rate of 16.3.
Sustained virologic response also was associated with lower CV risk, and the odds of attaining it were about 25% greater with DAAs vs. PEG/RBV. That might have played a role in the findings, since hepatitis C is known to be associated with CV disease and the virus has been found in atherosclerotic plaques.
Past investigations have been mixed on whether or not hepatitis C virus treatment reduces CV risk, but lead investigator Adeel Ajwad Butt, MD, professor of medicine at Cornell University, New York, said that his study was stronger than what has come before. He explained why, and also why the findings matter, in an interview at ID Week 2018, an annual scientific meeting on infectious diseases.
Most of the subjects were men, about a quarter were black, and the median age at baseline was 58 years.
Dr. Butt disclosed institutional research grants from Merck and Gilead.
SOURCE: Butt AA et al. ID Week 2018 abstract 930.
REPORTING FROM ID WEEK 2018
Omadacycline equivalent to linezolid for skin infections
SAN FRANCISCO – In early October, the Food and Drug Administration approved omadacycline (Nuzyra) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults.
The drug is a synthetic tetracycline designed to overcome some of the resistance mechanisms that can undermine traditional tetracycline drugs. It gained approval on the strength of the Oasis-1 (NCT03482011) and Oasis-2 (NCT03535194) trials, which demonstrated the drug’s noninferiority to linezolid.
At IDWeek 2018, researchers combined the data from the two pivotal trials to gain more power in some of the secondary endpoints, such as adverse events.
Paul McGovern, MD, vice president of clinical and medical affairs at Paratek, which markets omadacycline, discussed the results of the analysis at an annual scientific meeting on infectious diseases.
Combined, the two studies included 691 patients who received omadacycline and 689 who received linezolid. The two drugs achieved similar results for early clinical response, defined as at least a 20% reduction in lesion size 48-72 hours after the first dose. The mean reduction in baseline lesion area at day 3 was 53.4% in the omadacycline group and 53.0% in the linezolid group. At the end of the treatment period, those values were 93.9% and 93.7%, respectively, Dr. McGovern reported.
A total of 28.5% of patients receiving omadacycline reported drug-related treatment-emergent adverse events, compared with 16.1% of the linezolid group. The omadacycline group experienced higher frequency of nausea (21.9% vs. 8.7%) and vomiting (11.4% vs. 3.9%), he said.
The Oasis 1 and Oasis 2 studies were funded by Paratek. Dr. McGovern is an employee of Paratek.
SOURCE: McGovern P et al. IDWeek 2018, poster abstract 1347.
SAN FRANCISCO – In early October, the Food and Drug Administration approved omadacycline (Nuzyra) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults.
The drug is a synthetic tetracycline designed to overcome some of the resistance mechanisms that can undermine traditional tetracycline drugs. It gained approval on the strength of the Oasis-1 (NCT03482011) and Oasis-2 (NCT03535194) trials, which demonstrated the drug’s noninferiority to linezolid.
At IDWeek 2018, researchers combined the data from the two pivotal trials to gain more power in some of the secondary endpoints, such as adverse events.
Paul McGovern, MD, vice president of clinical and medical affairs at Paratek, which markets omadacycline, discussed the results of the analysis at an annual scientific meeting on infectious diseases.
Combined, the two studies included 691 patients who received omadacycline and 689 who received linezolid. The two drugs achieved similar results for early clinical response, defined as at least a 20% reduction in lesion size 48-72 hours after the first dose. The mean reduction in baseline lesion area at day 3 was 53.4% in the omadacycline group and 53.0% in the linezolid group. At the end of the treatment period, those values were 93.9% and 93.7%, respectively, Dr. McGovern reported.
A total of 28.5% of patients receiving omadacycline reported drug-related treatment-emergent adverse events, compared with 16.1% of the linezolid group. The omadacycline group experienced higher frequency of nausea (21.9% vs. 8.7%) and vomiting (11.4% vs. 3.9%), he said.
The Oasis 1 and Oasis 2 studies were funded by Paratek. Dr. McGovern is an employee of Paratek.
SOURCE: McGovern P et al. IDWeek 2018, poster abstract 1347.
SAN FRANCISCO – In early October, the Food and Drug Administration approved omadacycline (Nuzyra) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults.
The drug is a synthetic tetracycline designed to overcome some of the resistance mechanisms that can undermine traditional tetracycline drugs. It gained approval on the strength of the Oasis-1 (NCT03482011) and Oasis-2 (NCT03535194) trials, which demonstrated the drug’s noninferiority to linezolid.
At IDWeek 2018, researchers combined the data from the two pivotal trials to gain more power in some of the secondary endpoints, such as adverse events.
Paul McGovern, MD, vice president of clinical and medical affairs at Paratek, which markets omadacycline, discussed the results of the analysis at an annual scientific meeting on infectious diseases.
Combined, the two studies included 691 patients who received omadacycline and 689 who received linezolid. The two drugs achieved similar results for early clinical response, defined as at least a 20% reduction in lesion size 48-72 hours after the first dose. The mean reduction in baseline lesion area at day 3 was 53.4% in the omadacycline group and 53.0% in the linezolid group. At the end of the treatment period, those values were 93.9% and 93.7%, respectively, Dr. McGovern reported.
A total of 28.5% of patients receiving omadacycline reported drug-related treatment-emergent adverse events, compared with 16.1% of the linezolid group. The omadacycline group experienced higher frequency of nausea (21.9% vs. 8.7%) and vomiting (11.4% vs. 3.9%), he said.
The Oasis 1 and Oasis 2 studies were funded by Paratek. Dr. McGovern is an employee of Paratek.
SOURCE: McGovern P et al. IDWeek 2018, poster abstract 1347.
REPORTING FROM IDWEEK 2018
Key clinical point:
Major finding: The mean reduction in lesion area at the end of treatment was 93.9% for omadacycline and 93.7% for linezolid.
Study details: Meta-analysis of two trials with 691 patients receiving omadacycline and 689 patients receiving linezolid.
Disclosures: The Oasis-1 and Oasis-2 studies were funded by Paratek. Dr. McGovern is an employee of Paratek.
Source: McGovern P et al. IDWeek 2018, poster abstract 1347.
