Photo Credit CDC
# 6911
As everyone is probably already aware, we are in the middle of what may turn out to be the worst influenza season in a decade. Even with vaccination, the flu remains a serious health threat - particularly to those in high risk groups – making better treatment options a priority.
Antivirals are currently the only real treatment available (aside from supportive therapies) for influenza, and while recommended by the CDC, questions remain about the extent of their beneficial effects (see The CDC On The Value Of Antivirals).
How well antivirals work in preventing the shedding of influenza viruses, and whether combinations of antivirals might prove more useful for high risk patients, are questions that researchers have yet to fully answer.
So the NIAID plans two trials to evaluate these questions:
- Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults (NCT01314911)
- Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications (NCT01227967)
A third trial planned by NIAID will look at the safety and efficacy of an experimental treatment we’ve seen tried in China (with limited success) for bird flu cases; what is commonly called convalescent plasma (see Shanghai: Serum Treatment For H1N1).
Two years ago, in CID Journal: Convalescent Plasma Therapy For Severe H1N1, I described the process:
Blood is collected from people that have been infected and have recovered, and through a process called plasmapheresis, the blood cells are removed leaving only blood plasma.
This is done by passing the blood through a special filter, or by using a centrifuge. The remaining blood plasma will contain antibodies that could then be injected into severely ill patients.
Convalescent plasma could, theoretically, be used as either a treatment for someone already infected, or as a temporary prophylactic, to prevent infection.
There is more to it, of course.
The donor must be checked for a variety of blood borne diseases (i.e. hepatitis B, hepatitis C, Syphilis, and HIV), and then the plasma is usually heated to inactivate other possible pathogens.
Details on these new clinical trials are provided by the following NIH press release.
National Institute of Allergy and
Infectious Diseases (NIAID)
FOR IMMEDIATE RELEASE
Tuesday, Feb. 5, 2013
Three NIH-Sponsored Clinical Trials Test Influenza Treatments
Three clinical trials that seek to find more effective treatments for influenza are enrolling volunteers with influenza at the National Institutes of Health’s Clinical Center in Bethesda, Md., and at several dozen other domestic and international sites.
One study examines whether treatment with a licensed influenza drug, oseltamivir, reduces the time that infected people continue to produce virus in the upper airway.
A second tests whether a combination of three licensed flu antiviral drugs works better than oseltamivir alone in people with influenza who have chronic health conditions, such as heart or lung disease, that put them at greater risk of severe illness.
The third tests whether treatment with plasma enriched with anti-influenza antibodies improves the condition of hospitalized influenza patients compared to standard antiviral treatment alone.
<SNIP>
Although oseltamivir has been approved for use in the United States since 1999, no studies have shown conclusively whether the drug significantly reduces the amount of virus produced (shed) by an infected person. Reduced shedding would likely lessen the chances of an infected person passing the virus to others. The oseltamivir trial will enroll a total of approximately 560 people at 31 locations in the United States, Argentina and Thailand. Enrollees must be between the ages of 18 and 65 years and have confirmed influenza virus infection but not be hospitalized or suffering from any other health conditions that would put them at risk of developing influenza complications.
The trial comparing oral oseltamivir alone to treatment with oseltamivir plus two other licensed antiviral drugs is enrolling a total of up to 720 adults at sites in the United States, Argentina, Australia, Mexico and Thailand. In addition to having laboratory-confirmed influenza, enrollees must have at least one other characteristic that places them at higher risk of developing serious complications. Asthma and other lung disorders, heart disease, obesity, weakened immune function and being over age 65 are some of the conditions that place people at higher risk for serious disease.
The third trial is enrolling children as well as adults, including pregnant women, hospitalized with severe influenza. This trial aims to enroll a total of approximately 100 people at approximately 20 sites in the United States. All participants will receive standard drug treatment for influenza, and half will also receive two infusions of plasma enriched with antibodies against the virus. Antibodies are infection-fighting proteins produced by the immune system. The antibodies used in the trial are derived from blood donated by volunteers who were recently vaccinated against flu or are recovered from a recent bout of flu.
“Anecdotal evidence suggests that the addition of plasma with high levels of antibody against the virus may confer additional benefit over drug treatment alone. This trial will be one of the first to examine that possibility in a scientifically rigorous fashion,” said Dr. Davey. “The outcome of this trial may provide valuable data on how best to treat patients hospitalized with severe influenza.”
Information about the NIAID Influenza Research Collaboration, including a listing of all participating clinical sites worldwide, is available at FluResearch.org. Detailed information about each of the trials now enrolling volunteers is also available at ClinicalTrials.gov and through the following direct links:
- Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults (NCT01314911)
- Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications (NCT01227967)
- Safety and Efficacy of Investigational Immune Plasma in Treating Influenza A (NCT01052480)
For more about research on all aspects of influenza, visit the NIAID Flu portal. Also visit www.Flu.gov for one-stop access to U.S. government information on seasonal and pandemic flu.
