Peginterferon Alfa-2a in Patients with Chronic Hepatitis C

作者：Stefan Zeuzem, Saya V. Feinman, Jens W. F. Rasenack, Elizabeth Jenny Heathcote, Ming–Yang Lai, Edward John Gane, John O’Grady, Jürg Reichen, M. Diago, Amy Lin, Joseph H. Hoffman, Michael J. Brunda · 发表于：New England Journal of Medicine · 年份：2000 · DOI：10.1056/nejm200012073432301 · 被引用次数：1228 · 研究领域：Hepatitis C virus research、Rheumatoid Arthritis Research and Therapies、Liver Diseases and Immunity

BACKGROUND: Covalent attachment of a 40-kd branched-chain polyethylene glycol moiety to interferon alfa-2a results in a compound (peginterferon alfa-2a) that has sustained absorption, a slower rate of clearance, and a longer half-life than unmodified interferon alfa-2a. We compared the clinical effects of a regimen of peginterferon alfa-2a with those of a regimen of interferon alfa-2a in the initial treatment of patients with chronic hepatitis C. METHODS: We randomly assigned 531 patients with chronic hepatitis C to receive either 180 microg of peginterferon alfa-2a subcutaneously once per week for 48 weeks (267 patients) or 6 million units of interferon alfa-2a subcutaneously three times per week for 12 weeks, followed by 3 million units three times per week for 36 weeks (264 patients). All the patients were assessed at week 72 for a sustained virologic response, defined as an undetectable level of hepatitis C virus RNA (<100 copies per milliliter). RESULTS: In the peginterferon group, 223 of the 267 patients completed treatment and 206 completed follow-up. In the interferon group, 161 of the 264 patients completed treatment and 154 completed follow-up. In an intention-to-treat analysis in which patients who missed the examination at the end of treatment or follow-up were considered not to have had a response at that point, peginterferon alfa-2a was associated with a higher rate of virologic response than was interferon alfa-2a at week 48 (69 percent vs. 28 percent, P=0.001)...