May 31, 2001

New Therapy for Hepatitis C Shows Promise

From Medscape News

New York—Combination therapy with pegylated interferon alfa-2a (Pegasys) and the oral antiviral medication ribavirin is being touted as an alternative to the standard treatment for hepatitis C in findings released Tuesday at Digestive Disease Week 2001 being held in Atlanta, Georgia.

Michael W. Fried, MD, from University of North Carolina, Chapel Hill, and colleagues, found a higher sustained viral response rate among hepatitis C patients treated with this combination of drugs than with the current standard therapy, interferon alfa-2b plus ribavirin (Rebetron).

Release of results from this latest study, however, once again pits pharmaceutical giant Schering-Plough, which manufactures interferon alfa-2b (Intron A) as well as its pegylated counterpart (Peg-Intron), against Hoffman-La Roche, producer of Pegasys.

This multicenter phase III clinical trial enrolled 1149 patients, of whom 453 were treated with pegylated interferon alfa-2a plus oral ribavirin for 48 weeks, 224 patients received pegylated interferon alfa-2a plus placebo, and 444 received (nonpegylated) interferon alfa-2b plus ribavirin. Patients who received the new combination therapy (pegylated interferon alfa-2a and ribavirin) achieved a 56% sustained viral response rate compared with 45% for those receiving standard interferon alfa-2b plus ribavirin, and 30% for those in the placebo group. Sustained viral response was defined as clearance of virus with normal serum aminotransferases 6 months after the end of treatment. Investigators note that of the 298 patients who received pegylated interferon alfa-2a plus oral ribavirin combination therapy, who were infected with hepatitis C genotype 1, 46% attained a sustained viral response rate compared with 37% of the 285 patients with this genotype treated with standard of care.

In a statement to media, Dr. Fried noted, "This is the most difficult-to-treat population and the most prevalent genotype in the United States. We are very pleased with this impressive response rate for genotype 1."

Dr. Fried and colleagues also reported that depression and flu-like symptoms, common adverse effects of treatment for hepatitis C, occurred less frequently in those treated with pegylated interferon alfa-2a plus ribavirin than in comparison groups.

In January 2000, Hoffman-La Roche filed lawsuits against Schering-Plough in the United States and France for infringement of pegylated interferon patents.

Schering-Plough also licenses exclusive rights to market ribavirin from ICN Pharmaceuticals. Until the introduction of Peg-Intron, Schering would only sell the drug bundled with interferon alfa-2b.

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