Largest study comparing leading hepatitis C treatments
- Largest study comparing leading hepatitis C treatments
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
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
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
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
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