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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
Planning for ventilator-dependent patients during natural disasters

SAN ANTONIO – For patients with neuromuscular disorders, the stress and danger from natural disasters such Hurricane Harvey are best avoided by leaving the area as soon as possible, according to Venessa A. Holland, MD, FCCP, of Houston Methodist Hospital.
While none of Dr. Holland’s patients died during this catastrophic hurricane, there were considerable challenges, particularly for those trapped by the many trillion gallons of water fell on Texas and Louisiana in August 2017. Houston was flooded, and hospitals and other medical facilities were hit hard. The vulnerability of ventilator-dependent and incapacitated patients was of particular concern.
In one case, a ventilator-dependent patient trapped by flood waters at home became diaphoretic and hypotensive. The patient was treated with electrolyte-replacement sports drink administered via percutaneous endoscopic gastrostomy (PEG) tube, Dr. Holland told attendees at the annual meeting of the American College of Chest Physicians.
Dr. Holland spoke in a video interview about how neuromuscular disorder patients fared during Hurricane Harvey and her recommendations for the next natural disaster.
Dr. Holland disclosed that she previously served as a consultant to Hill-Rom.

SAN ANTONIO – For patients with neuromuscular disorders, the stress and danger from natural disasters such Hurricane Harvey are best avoided by leaving the area as soon as possible, according to Venessa A. Holland, MD, FCCP, of Houston Methodist Hospital.
While none of Dr. Holland’s patients died during this catastrophic hurricane, there were considerable challenges, particularly for those trapped by the many trillion gallons of water fell on Texas and Louisiana in August 2017. Houston was flooded, and hospitals and other medical facilities were hit hard. The vulnerability of ventilator-dependent and incapacitated patients was of particular concern.
In one case, a ventilator-dependent patient trapped by flood waters at home became diaphoretic and hypotensive. The patient was treated with electrolyte-replacement sports drink administered via percutaneous endoscopic gastrostomy (PEG) tube, Dr. Holland told attendees at the annual meeting of the American College of Chest Physicians.
Dr. Holland spoke in a video interview about how neuromuscular disorder patients fared during Hurricane Harvey and her recommendations for the next natural disaster.
Dr. Holland disclosed that she previously served as a consultant to Hill-Rom.

SAN ANTONIO – For patients with neuromuscular disorders, the stress and danger from natural disasters such Hurricane Harvey are best avoided by leaving the area as soon as possible, according to Venessa A. Holland, MD, FCCP, of Houston Methodist Hospital.
While none of Dr. Holland’s patients died during this catastrophic hurricane, there were considerable challenges, particularly for those trapped by the many trillion gallons of water fell on Texas and Louisiana in August 2017. Houston was flooded, and hospitals and other medical facilities were hit hard. The vulnerability of ventilator-dependent and incapacitated patients was of particular concern.
In one case, a ventilator-dependent patient trapped by flood waters at home became diaphoretic and hypotensive. The patient was treated with electrolyte-replacement sports drink administered via percutaneous endoscopic gastrostomy (PEG) tube, Dr. Holland told attendees at the annual meeting of the American College of Chest Physicians.
Dr. Holland spoke in a video interview about how neuromuscular disorder patients fared during Hurricane Harvey and her recommendations for the next natural disaster.
Dr. Holland disclosed that she previously served as a consultant to Hill-Rom.
REPORTING FROM CHEST 2018
Latest clinical trials advance COPD management

SAN ANTONIO – Recent studies have shown that the use of a long-acting beta2-agonist/long-acting muscarinic antagonist (LABA/LAMA) combination is superior to LAMA alone in endpoints including exacerbation, Nicola A. Hanania, MD, FCCP, said in a panel discussion session at the annual meeting of the American College of Chest Physicians.
Other recent evidence has shown that the use of LABA/LAMA has cardiovascular benefits in hyperinflated patients with COPD, according to Dr. Hanania, director of the Airways Clinical Research Center at Baylor College of Medicine, Houston.
Meanwhile, emerging data in patients with advanced COPD have demonstrated the benefits of single-inhaler triple therapy with inhaled corticosteroid (ICS)/LABA/LAMA versus LABA/LAMA or ICS/LABA combinations, Dr. Hanania said in an interview.
The past year also has brought news that ICS de-escalation is possible in patients with moderate COPD with no exacerbation risk, though it may not be possible in patients with high baseline blood eosinophils, he added.
Recent developments have not all been about drug therapy. The Zephyr endobronchial valve improved outcomes in patients with little to no collateral ventilation in target lobes, Dr. Hanania said. However, the therapy comes with a potential risk of pneumothorax, so patients need to be monitored in the hospital.
Dr. Hanania provided disclosures related to Roche (Genentech), AstraZeneca, Boehringer Ingelheim, Novartis, GlaxoSmithKline, and Sanofi/Regeneron, as well as institutional research grant support from the National Heart, Lung, and Blood Institute and the American Lung Association.

SAN ANTONIO – Recent studies have shown that the use of a long-acting beta2-agonist/long-acting muscarinic antagonist (LABA/LAMA) combination is superior to LAMA alone in endpoints including exacerbation, Nicola A. Hanania, MD, FCCP, said in a panel discussion session at the annual meeting of the American College of Chest Physicians.
Other recent evidence has shown that the use of LABA/LAMA has cardiovascular benefits in hyperinflated patients with COPD, according to Dr. Hanania, director of the Airways Clinical Research Center at Baylor College of Medicine, Houston.
Meanwhile, emerging data in patients with advanced COPD have demonstrated the benefits of single-inhaler triple therapy with inhaled corticosteroid (ICS)/LABA/LAMA versus LABA/LAMA or ICS/LABA combinations, Dr. Hanania said in an interview.
The past year also has brought news that ICS de-escalation is possible in patients with moderate COPD with no exacerbation risk, though it may not be possible in patients with high baseline blood eosinophils, he added.
Recent developments have not all been about drug therapy. The Zephyr endobronchial valve improved outcomes in patients with little to no collateral ventilation in target lobes, Dr. Hanania said. However, the therapy comes with a potential risk of pneumothorax, so patients need to be monitored in the hospital.
Dr. Hanania provided disclosures related to Roche (Genentech), AstraZeneca, Boehringer Ingelheim, Novartis, GlaxoSmithKline, and Sanofi/Regeneron, as well as institutional research grant support from the National Heart, Lung, and Blood Institute and the American Lung Association.

SAN ANTONIO – Recent studies have shown that the use of a long-acting beta2-agonist/long-acting muscarinic antagonist (LABA/LAMA) combination is superior to LAMA alone in endpoints including exacerbation, Nicola A. Hanania, MD, FCCP, said in a panel discussion session at the annual meeting of the American College of Chest Physicians.
Other recent evidence has shown that the use of LABA/LAMA has cardiovascular benefits in hyperinflated patients with COPD, according to Dr. Hanania, director of the Airways Clinical Research Center at Baylor College of Medicine, Houston.
Meanwhile, emerging data in patients with advanced COPD have demonstrated the benefits of single-inhaler triple therapy with inhaled corticosteroid (ICS)/LABA/LAMA versus LABA/LAMA or ICS/LABA combinations, Dr. Hanania said in an interview.
The past year also has brought news that ICS de-escalation is possible in patients with moderate COPD with no exacerbation risk, though it may not be possible in patients with high baseline blood eosinophils, he added.
Recent developments have not all been about drug therapy. The Zephyr endobronchial valve improved outcomes in patients with little to no collateral ventilation in target lobes, Dr. Hanania said. However, the therapy comes with a potential risk of pneumothorax, so patients need to be monitored in the hospital.
Dr. Hanania provided disclosures related to Roche (Genentech), AstraZeneca, Boehringer Ingelheim, Novartis, GlaxoSmithKline, and Sanofi/Regeneron, as well as institutional research grant support from the National Heart, Lung, and Blood Institute and the American Lung Association.
REPORTING FROM CHEST 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
ADVENT-HF early results: High ASV compliance, no safety concerns
SAN ANTONIO – The in heart failure patients with sleep apnea, so far has better compliance than previous trials, with no safety concerns to date, according to investigator T. Douglas Bradley, MD.
On average, patients with obstructive sleep apnea were using the device 4.6 hours per night at 1 month and 4.1 hours at 12 months, while patients with central sleep apnea were using the device 5.2 hours per night both at 1 month and 12 months, Dr. Bradley said.
“This represents much better compliance than the other trials that have looked into this area, so we are quite happy about that,” Dr. Bradley said at the annual meeting of the American College of Chest Physicians.
The study has been reviewed five times by the data safety monitoring board since the announcement of SERVE-HF trial results, with no safety concerns in either obstructive sleep apnea or central sleep apnea patients, Dr. Bradley noted in a podium presentation.
The compliance results have been submitted for publication, though efficacy results of the study will have to wait. The estimated study completion date is June 2020, according to the latest study information on ClinicalTrials.gov.
More than 600 patients have been enrolled in ADVENT-HF to date, and the investigators hope to enroll more than 800: “We should be there by the end of next year,” Dr. Bradley said.
He provided disclosures related to Philips Respironics (funding and devices) and the Canadian Institutes of Health Research.
SAN ANTONIO – The in heart failure patients with sleep apnea, so far has better compliance than previous trials, with no safety concerns to date, according to investigator T. Douglas Bradley, MD.
On average, patients with obstructive sleep apnea were using the device 4.6 hours per night at 1 month and 4.1 hours at 12 months, while patients with central sleep apnea were using the device 5.2 hours per night both at 1 month and 12 months, Dr. Bradley said.
“This represents much better compliance than the other trials that have looked into this area, so we are quite happy about that,” Dr. Bradley said at the annual meeting of the American College of Chest Physicians.
The study has been reviewed five times by the data safety monitoring board since the announcement of SERVE-HF trial results, with no safety concerns in either obstructive sleep apnea or central sleep apnea patients, Dr. Bradley noted in a podium presentation.
The compliance results have been submitted for publication, though efficacy results of the study will have to wait. The estimated study completion date is June 2020, according to the latest study information on ClinicalTrials.gov.
More than 600 patients have been enrolled in ADVENT-HF to date, and the investigators hope to enroll more than 800: “We should be there by the end of next year,” Dr. Bradley said.
He provided disclosures related to Philips Respironics (funding and devices) and the Canadian Institutes of Health Research.
SAN ANTONIO – The in heart failure patients with sleep apnea, so far has better compliance than previous trials, with no safety concerns to date, according to investigator T. Douglas Bradley, MD.
On average, patients with obstructive sleep apnea were using the device 4.6 hours per night at 1 month and 4.1 hours at 12 months, while patients with central sleep apnea were using the device 5.2 hours per night both at 1 month and 12 months, Dr. Bradley said.
“This represents much better compliance than the other trials that have looked into this area, so we are quite happy about that,” Dr. Bradley said at the annual meeting of the American College of Chest Physicians.
The study has been reviewed five times by the data safety monitoring board since the announcement of SERVE-HF trial results, with no safety concerns in either obstructive sleep apnea or central sleep apnea patients, Dr. Bradley noted in a podium presentation.
The compliance results have been submitted for publication, though efficacy results of the study will have to wait. The estimated study completion date is June 2020, according to the latest study information on ClinicalTrials.gov.
More than 600 patients have been enrolled in ADVENT-HF to date, and the investigators hope to enroll more than 800: “We should be there by the end of next year,” Dr. Bradley said.
He provided disclosures related to Philips Respironics (funding and devices) and the Canadian Institutes of Health Research.
REPORTING FROM CHEST 2018
Dogs steal the show at CHEST 2018
SAN ANTONIO – Therapy Animals of San Antonio, a non-profit organization that trains and places therapy pets, delighted the attendees of CHEST 2018 with a number of therapy dogs. Christopher L. Carroll, MD, FCCP, and Kathy Jewett, CHEST Director, Membership and Brand Development, spoke about the many benefits pets can bring to patients, including stress reduction and emotional comfort. The therapy dogs also will be visiting the CHEST 2018 meeting on Tuesday and Wednesday, 11:30 a.m. to 1:30 p.m., in the Exhibit Hall.
SAN ANTONIO – Therapy Animals of San Antonio, a non-profit organization that trains and places therapy pets, delighted the attendees of CHEST 2018 with a number of therapy dogs. Christopher L. Carroll, MD, FCCP, and Kathy Jewett, CHEST Director, Membership and Brand Development, spoke about the many benefits pets can bring to patients, including stress reduction and emotional comfort. The therapy dogs also will be visiting the CHEST 2018 meeting on Tuesday and Wednesday, 11:30 a.m. to 1:30 p.m., in the Exhibit Hall.
SAN ANTONIO – Therapy Animals of San Antonio, a non-profit organization that trains and places therapy pets, delighted the attendees of CHEST 2018 with a number of therapy dogs. Christopher L. Carroll, MD, FCCP, and Kathy Jewett, CHEST Director, Membership and Brand Development, spoke about the many benefits pets can bring to patients, including stress reduction and emotional comfort. The therapy dogs also will be visiting the CHEST 2018 meeting on Tuesday and Wednesday, 11:30 a.m. to 1:30 p.m., in the Exhibit Hall.
REPORTING FROM CHEST 2018
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.