KENILWORTH, N.J. -- 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 (peginterferon alfa- 2b/Schering Corporation) vs. 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 bloodborne 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, MD, FRACP, medical director of liver
research at Duke University Medical Center, and Mark S. Sulkowski, MD,
assistant professor of medicine in the Division of Infectious Diseases at 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: http://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
"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
The IDEAL study will compare the efficacy and safety of individualized
weight-based dosing with PEG-INTRON and REBETOL (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
"These two treatment regimens have never before been directly compared in
a study of this magnitude," said Robert J. Spiegel, MD, 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."
Source: Schering-Plough Corporation