Study Results Presented on New Hepatitis C Therapy - Data on
Peginterferon Alfa-2b Suggests New, Improved Therapy is on the
SAN DIEGO, May 22 /PRNewswire/ -- The results of a worldwide
multi-center clinical trial indicates that patients with hepatitis
C, a virus that causes potentially fatal liver disease, may soon
have access to a new treatment option. The study results were
presented yesterday at the Digestive Disease Week meeting in San
The study, led by Karen L. Lindsay, MD, Associate Professor of
Clinical Medicine, Gastrointestinal and Liver Diseases at the Keck
School of Medicine of the University of Southern California, found
that peginterferon alfa-2b administered once weekly is twice as
effective than standard interferon alfa-2b as monotherapy for
treating hepatitis C, and was just as well tolerated. The current
"gold standard" of treatment for hepatitis C is combination therapy
with interferon alfa-2b, administered three times weekly with daily
doses of oral ribavirin.
"The results of this study are very promising for hepatitis C
patients," said Dr. Lindsay. "Since peginterferon alfa-2b has been
shown to be effective alone, we anticipate that it may be even more
effective when used in combination with ribavirin. I expect this
combination therapy to become the optimal treatment for hepatitis C
in the future." Combination therapy with peginterferon alfa-2b and
ribavirin is currently in Phase III clinical trials.
Pegylation involves the attachment of polyethylene glycol to the
interferon molecule. Pegylation results in slower clearance of the
interferon molecule, allowing it to remain in the bloodstream
longer, therefore providing a more convenient once-weekly dosing
schedule for patients.
Hepatitis C, when left untreated, can lead to cirrhosis
(scarring of the liver), liver failure and death, as well as
primary liver cancer. It is the leading cause of liver
transplantation in the United States and patients often remain
without specific symptoms for as long as three decades. Hepatitis C
is the most common blood borne infection in the United States, and
is estimated to infect nearly 4 million Americans. Approximately
10,000 Americans die from chronic liver disease due to hepatitis C
annually, and that death rate is expected to triple in the next 10
to 20 years.
The aim of the multi-center clinical trial was to establish the
safety and effectiveness of peginterferon alfa-2b in comparison to
standard interferon alfa-2b. Participants had never been treated
for hepatitis C prior to this study.
Patients participating in the study were divided into four
groups, receiving either 0.5 ug/kg, 1.0 ug/kg, or 1.5 ug/kg of
peginterferon alfa-2b once weekly, or the standard dose of
interferon alfa-2b (three million international units three times
Results showed that patients treated with all doses of
peginterferon alfa-2b had significantly lower levels of detectable
virus during treatment, at the end of treatment, and after 24 weeks
of follow up, than the group who received the standard interferon.
Patients in the peginterferon alfa-2b groups achieved sustained
virologic responses (no detectable virus in the blood for 24 weeks
after discontinuing treatment) of 18%, 25% and 23% respectively,
compared to 12% for the standard interferon group. However,
combination therapy with standard interferon alfa-2b and ribavirin
remains the most effective treatment available, with sustained
virologic response rates of about 40%.
"Once approved for marketing, peginterferon alfa-2b will be
another important addition to the hepatitis C treatment arsenal,"
said Dr. John McHutchison, Medical Director of Liver
Transplantation at the Scripps Clinic and Research Foundation in La
Jolla, CA and a participating investigator in the study. "The once
weekly dosing schedule should make treatment more convenient for
patients with hepatitis C, and improve patient compliance."
Founded in 1885, the Keck School of Medicine of the University
of Southern California is a major center for basic and clinical
biomedical research, especially in the fields of cancer, gene
therapy, the neurosciences and transplantation biology. With more
than 960 full-time faculty, the Keck School serves more than one
million patients each year through 14 affiliated hospitals in
Southern California, including USC University Hospital, USC/Norris
Comprehensive Cancer Center, Doheny Eye Institute, Childrens
Hospital Los Angeles and Los Angeles County+USC Medical Center, one
of the largest teaching hospitals in the nation.
CONTACT: Maria De Trizio of Ruder Finn, 212-583-2766, for the
University of Southern California.
SOURCE University of Southern California
Home | What is HCV | Transmission |
| Lab |
Links | Transplant |