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On December 3, 2002 Copegus" (ribavirin; Roche) was approved by the FDA as part of combination therapy with newly approved Pegasys® for chronic hepatitis C (HCV) infection for patients with compensated liver disease who have not previously been treated with interferon alpha.

Nearly 2.7 million Americans are chronically infected with hepatitis C virus.

Two pivotal phase III studies have been cited as demonstrating the efficacy of Pegasys® and Copegus" combination therapy for the effective treatment of patients with chronic hepatitis C.

The first study enrolled 1284 persons with HCV infection and showed that patients with a strain of HCV known as genotype non-1 (predominately 2 and 3) achieved the same desired sustained viroligical response (SVR) in a 24 week regimen consisting of 180 mg Pegasys® subcutaneously weekly and 800 mg Copegus" by mouth daily when compared to 48 weeks of treatment. The shorter duration of treatment also produced fewer side effects in patients.1

The second study demonstrated that once weekly injectable Pegasys® 180 mcg and daily oral Copegus" 1000 to 1200 mg (depending on body weight) was more effective than standard HCV therapy that including thrice-weekly injections and daily oral ribavirin. SVR was achieved in 53% of patients on the Pegasys® and Copegus" therapy as compared to 44% in the standard treatment arm.2

The most common side effects of Pegasys® and Copegus" therapy include fatigue/asthenia, headache, pyrexia, myalgia and anxiety among others. As with all ribavirin therapy Pegasys® and Copegus" therapy in contraindicated in pregnant women and men whose female partners who are pregnant.

For more information on Pegasys® and Copegus" please call



Refs

1. Hadziyannis, S et al. Abstracts of the 37th meeting of the European Association for the Study of the Liver (EASL) 2002. Madrid, April 18 2002. Abstract 536.

2 Freid M et al. N Engl J Med 2002; 347: