A Virginia Commonwealth University researcher is part of a study that shows the drug peginterferon alfa-2a, also referred to as Pegasys, is superior to other forms of interferon in the treatment of patients with chronic hepatitis C virus infection.
Interferon, alone or in combination with an anti-viral drug, is the only
effective therapy for hepatitis C.
Published in the 7 December 2000 issue of the New England Journal of Medicine, the study involved 271 patients and 22 U.S., Canadian and Australian medical centers, including VCU's Medical College of Virginia Hospitals. Compared to many previous studies of patients with chronic hepatitis C., this study was unique in that only patients with advanced liver disease, those with advanced fibrosis and cirrhosis, were treated.
"Hepatitis C patients -- both in the early stages of the disease and those with cirrhosis -- are in dire need of more effective treatments," said
Mitchell L. Shiffman, M.D., medical director of VCU's Hepatology-Liver
Transplant Program and the study's lead U.S. investigator. "This study
clearly demonstrates that Pegasys is superior to standard forms of interferon
in the treatment of chronic hepatitis C."
Pegasys was developed by attaching a non-toxic compound called PEG to the interferon. This alters the interferon drug so that it lasts longer in the
body, has less side effects and at the same time is more effective against the
hepatitis C virus. Standard interferon is administered three times weekly.
Pegasys needs to be administered only once weekly.
In this study, 30 percent of patients with advanced liver disease treated with Pegasys lost all evidence of hepatitis C virus, compared to 6 percent of patients treated with standard interferon alfa-2a. Patients are considered to be virus-free or have a sustained viral clearance when the virus doesn't return after drug treatments stop. In this study, patients were treated for 48 weeks with Pegasys and followed for an additional 24 weeks after the
"The first priority is to eradicate the virus. However, the findings in
this study are also demonstrate that Pegasys is also beneficial to a large
number of patients in whom sustained viral clearance was not attained,"
Shiffman said. "What we've learned is that it may possible for patients to
show an improvement in the liver disease following treatment with Pegasys even
if this treatment did not get rid of the virus."
In this study, patients randomly received either Pegasys weekly or
interferon alfa-2a three times weekly. Researchers conducted liver biopsies
on participants both before and after the treatment. The results showed that
even when they were not virus-free, 54 percent of patients treated with
Pegasys showed improvement in underlying liver damage, compared to 31 percent
of patients treated with standard interferon.
Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis and liver cancer. It is also the primary reason for liver transplantation in the United States. An estimated 2.7 million Americans are chronically infected with the virus, with about 35,000 new infections reported each year.
The virus is transmitted through body fluids, primarily blood or blood
products, and by sharing needles. In many patients, the mode of transmission
is unknown. Unfortunately, most people infected with hepatitis C are unaware
of it because it may take years for symptoms to develop.
According to the Centers for Disease Control and Prevention estimates,
hepatitis C is responsible for up to 10,000 deaths per year in the United
States. The CDC projects that annual rate could increase to 38,000 by the
year 2010, surpassing the number of deaths attributed annually to HIV/AIDS.
The study was funded by a research grant from F. Hoffmann-La Roche, Ltd., of Basel, Switzerland, the manufacturer of Pegasys. An application for
Pegasys was filed with the Food and Drug Administration on May 22.