Hepatitis Weekly (10.13.03) - Wednesday, October 22, 2003
In hopes of refining treatment practices for hepatitis C,
researchers at Duke University Medical Center and the Johns
Hopkins University School of Medicine will lead the first ever
direct comparison of two leading treatments for the infection.
Hepatitis C infects nearly 3.9 million Americans, according to
CDC. Approximately 70 percent of patients have chronic
hepatitis C, which can cause cirrhosis and liver cancer and is
the leading indication for liver transplantation in the United
States.
A combination of interferon and ribavirin is the most common
hepatitis C treatment. A recent advance has been pegylated
interferon, which improves pharmacokinetic characteristics
compared to standard interferon, allowing more convenient
weekly dosing instead of three times a week.
The study - led by John McHutchinson, MD, director of
gastroenterology and hepatology research at the Duke Clinical
Research Institute, and Mark Sulkowski, MD, assistant
professor of medicine at Johns Hopkins - will compare three
treatment regimens in 2,880 hepatitis C patients. The trial,
IDEAL (Individualized Dosing Efficacy vs. flat dosing to
Assess optimaL pegylated interferon therapy) is sponsored by
the Schering-Plough Research Institute. Patients will be given
one of two available pegylated interferon treatments -
pegylated interferon alfa-2b (PEG-INTRON, by Schering-Plough
Corp.) and pegylated interferon alfa-2a (PEGASYS, by Hoffman-
LaRoche Inc.) - combined with ribavirin.
"The beginning of this trial is truly a milestone in research
for treatments of hepatitis C virus," said McHutchinson. "This
is the first time we have directly compared these two
treatments in a head-to-head manner. We hope to learn
important information that will directly impact the treatment
of our hepatitis C patients."
The trial will enroll patients from 100 different sites
nationwide. Dosing is one of the primary differences between
the two treatments, scientists said. Alfa-2a is given in the
same dosage to all patients, while Alfa-2b is given based on
the individual patient's weight. The trial's goal is to
determine which treatment results in a sustained viral
response (an undetectable level of virus in the patient's
blood 24 weeks after the end of therapy) in the largest
proportion of patients.
"By eradicating the virus during and after therapy, we are
able to forestall, and in many cases, prevent further damage
to the liver. This has a huge impact on patient health and
quality of life and translates into prolonged survival, a
lower incidence of liver cancer and may prevent the need for
liver transplantation," said McHutchinson, who has served as a
paid consultant to Schering and has received research support
and lectured on behalf of both Schering-Plough and Hoffman-
LaRoche.