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Nation’s
Top Medical Centers Seek Participants for 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 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: 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 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.”
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