Feb 5, 2013 (CIDRAP News) – Three large, multi-center studies now in the enrollment stage will assess whether such approaches as a combination of antiviral drugs or the use of borrowed antibodies can improve on existing treatments for influenza, the National Institutes of Health (NIH) announced today.
The three trials are enrolling volunteers at the NIH's Clinical Center in Bethesda, Md., and at dozens of other sites in the United States and abroad, the NIH said in a press release.
In announcing the studies, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), observed that this year's flu season began early and has been unusually hard on elderly people.
"We need better ways to treat people with influenza, which kills thousands of people in the United States each year, and clinical research supported by NIAID helps to address that need," he said.
Officials said the studies are sponsored by the NIAID Influenza Research Collaboration, a clinical research network funded by the NIAID Division of Clinical Research (DCR). Researchers at 36 sites in the United States and sites in Argentina, Australia, Mexico, and Thailand participate. Coordinators of the project are Richard Davey, MD, deputy clinical director of the NIAID DCR, and John Beigel, MD, medical affairs scientist on contract with the NIAID.
One study will assess whether treatment with oseltamivir (Tamiflu) shortens the time that people infected with flu produce virus in the upper airway, the NIH said. No studies have shown conclusively whether the drug, approved in the United States since 1999, significantly reduces the amount of virus shed by an infected person, the agency said. The trial aims to enroll a total of about 560 non-elderly adults with confirmed flu infections at 31 locations in the United States, Argentina, and Thailand.
Another study will examine whether a combination of three licensed antivirals—oseltamivir, amantadine, and ribavirin—works better than oseltamivir alone in patients who have flu along with one or more chronic conditions that increase their risk for flu complications. Plans call for enrolling up to 720 adults at sites in the United States, Argentina, Australia, Mexico, and Thailand.
The NIH said the third trial will look at whether using oseltamivir plus flu antibodies derived from other patients works better than oseltamivir alone in patients hospitalized with severe flu. The aim is to include about 100 children and adults, including pregnant women, at around 20 sites in the United States. The antibodies to be used in the study are derived from blood given by volunteers who were recently vaccinated against flu or recovered from the illness.
"Anecdotal evidence suggests that the addition of plasma with high levels of antibody against the virus may confer additional benefit over drug treatment alone," Davey said in the press release. "This trial will be one of the first to examine that possibility in a scientifically rigorous fashion."
Feb 5 NIH press release
Details of combination antiviral trial
Details of study on oseltamivir and viral shedding
Details of study on using flu antibodies to treat hospitalized flu patients
Information about the NIAID Influenza Research Collaboration