Roche announced that the U.S. Food and Drug Administration (FDA) has approved combination therapy with Pegasys (peginterferon alfa-2a), a pegylated interferon, and Copegus (ribavirin) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha.Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).

Pegasys and Copegus combination therapy was granted priority review designation by the FDA.Pegasys was approved as monotherapy for the treatment of adults with chronic hepatitis C on October 16, 2002.Currently, 2.7 million Americans are chronically infected with hepatitis C.

"Roche has taken a leadership role in advancing hepatitis C therapy by researching approaches to reduce the duration of treatment with Pegasys and Copegus and the dose of Copegus therapy for certain patients," said George B. Abercrombie, President & Chief Executive Officer -- Hoffmann-La Roche Inc. "Today, Roche can proudly offer Americans with hepatitis C a new treatment choice-Pegasys and Copegus combination therapy."

"Different genotypes of the hepatitis C virus need to be approached differently.Certain genotypes of the hepatitis C virus are easier to treat while others are stubborn and more difficult to treat," said Pegasys investigator, David Bernstein, Director of Hepatology at North Shore University Hospital, Manhasset, NY."With Pegasys combination therapy, we can now tailor the dose and duration of a patient's therapy to the genotype of the virus."