Medical centers, hospitals, clinics and other treatment sites across the country are actively enrolling Americans with the
hepatitis C virus (HCV) in a nationwide study that will for the first time determine which of the two FDA-approved pegylated interferon therapy regimens offers patients the best chance to eliminate the
virus. The regimens being compared are
PEG-INTRON(R) (peginterferon alfa- 2b/Schering Corporation) versus
PEGASYS (peginterferon alfa-2a/ Hoffmann-La Roche, Inc.), both used in combination with
ribavirin.
Hepatitis C, a potentially fatal virus that infects the liver, blood and other tissues, is the most common blood-borne infection in America, and is the leading cause of liver transplantation in the United States, according to the National Institutes of Health. Approximately 4 million Americans, or about one in every 50 adults, are now infected with HCV,(1) compared to 900,000 Americans with HIV.
A total of 2,880 patients at up to 100 U.S. sites will join the IDEAL study, which stands for Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy. The study is led by co-principal investigators John G. McHutchison, M.D., FRACP, Medical Director, Liver Research, Duke University Medical Center, and Mark S. Sulkowski, M.D., assistant professor of medicine in the Division of Infectious Diseases, Johns Hopkins University School of Medicine.
IDEAL study sites currently open to patient enrollment can be identified via zip code search on the study's Web site: www.idealstudy.com. Patients are encouraged to check the Web site on an ongoing basis as additional study sites will be opening enrollment in the coming weeks and will be added to the Web site at that time.
Unlike some clinical studies, where patients receive either active drug or placebo, all participates in the IDEAL study will receive active treatment at no cost.
"The IDEAL Study offers an excellent opportunity to collect more data on hepatitis C treatment," said Alan Brownstein, president and chief executive officer of the American Liver Foundation. "Treating HCV is a long and arduous process. To give people the best chance for success in the future, we need more information."