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Highest sustained virologic response in treatment of Hepatitis C ever reported in prospective study

A combination treatment of Pegasys (peginterferon alfa-2a 40kd) a pegylated interferon, with ribavirin, an orally active anti-viral medication, has shown some of the most effective treatment rates yet for individuals with hepatitis C. The combination treatment yielded a 61 percent sustained virologic response (SVR), the highest SVR ever reported in a prospective trial for a pegylated interferon using an intent-to-treat (ITT) analysis, according to Dr. Donald Jensen at Rush-Presbyterian-St. Luke's Medical Center.

SVR refers to a patient's continued undetectable serum hepatitis C (HCV) RNA levels six months after discontinuation of treatment. Results of a recently completed phase III study of the investigational hepatitis C therapy were presented today at the European Association for the Study of Liver (EASL) annual meeting in Madrid, Spain.

The study also revealed strong evidence that, to achieve optimal results, treatment regimens should be based on hepatitis C virus genotype, rather than on the traditional, weight-based methodology.

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.

"These results are unprecedented," explained Jensen, a U.S. investigator in the trial and director of Hepatology at Rush-Presbyterian St. Luke's Medical Center, Chicago. "Physicians can confidently expect that when Pegasys is available they can prescribe it for the most appropriate length and dose of combination treatment based on a patient's genotype and achieve optimal results." Rush-Presbyterian St. Luke's Medical Center was one of 29 U.S. trial locations.

The study also found a 51 percent SVR, the highest ever achieved, for patients with genotype 1, the most difficu
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Contact: John M. Pontarelli
jpontare@rsh.net
312-942-5949
Rush University Medical Center
18-Apr-2002


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