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."
The IDEAL study will compare the efficacy and safety of individualized weight-based dosing with PEG-INTRON and REBETOL(R) (ribavirin, USP) to PEGASYS, which is administered as a flat dose to all patients regardless of individual body weight, and COPEGUS (ribavirin, USP) dosed either at 1,000 mg or 1,200 mg daily, in U.S. patients chronically infected with hepatitis C, genotype 1. Genotype 1 is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infection among Americans. PEG-INTRON is a form of interferon alfa-2b that has been chemically "pegylated" so it is retained in the body longer than standard interferon, thereby providing for once weekly administration. PEGASYS is a pegylated form of interferon alfa-2a.
IDEAL is sponsored by Schering-Plough Research Institute (SPRI) and is being conducted to respond to questions raised by the hepatitis C medical and patient communities.
"These two treatment regimens have never before been directly compared in a study of this magnitude," said Robert J. Spiegel, M.D., senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute. "We are confident that the results of this large head-to- head study between PEG-INTRON and PEGASYS will help doctors and patients determine the therapy that offers them the best chance for achieving a sustained virologic response." http://www.schering-plough.com