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News From the Food and Drug Administration
December 4, 2002

New Treatment for Hepatitis C

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JAMA. 2002;288(21):2678. doi:10.1001/jama.288.21.2678-JFD20012-2-1

The FDA has approved peg-interferon alfa-2a (Pegasys; Hoffmann-La Roche Ltd, Nutley, NJ) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alfa. The product was approved on the basis of the results of three randomized, open-label, active-controlled clinical studies with approximately 1500 adult patients whose condition is described in the indication. All patients received therapy by subcutaneous injection for 48 weeks and were followed up for an additional 24 weeks. One of the studies was designed to enroll only patients with cirrhosis or transition to cirrhosis, and such patients were included also in the other two trials.