Peginterferon Alfa-2a plus Ribavirin for Chronic Hepatitis C Virus Infection

Michael Fried(University of North Carolina at Chapel Hill), Mitchell L. Shiffman(Virginia Commonwealth University Medical Center), K. Rajender Reddy(University of Miami), Coleman I. Smith, George Marinos(Prince of Wales Hospital), Fernando Lopes Gonçales(Universidade Estadual de Campinas (UNICAMP)), Dieter Häussinger(Heinrich Heine University Düsseldorf), M. Diago(Hospital General Universitario De Valencia), Giampiero Carosi(University of Brescia), Daniel Dhumeaux, Antonio Craxı̀(University of Palermo), Amy Lin, Joseph H. Hoffman, Jian Yu
New England Journal of Medicine
September 25, 2002
Cited by 6,396

Abstract

BACKGROUND\nTreatment with peginterferon alfa-2a alone produces significantly higher sustained virologic responses than treatment with interferon alfa-2a alone in patients with chronic hepatitis C virus (HCV) infection. We compared the efficacy and safety of peginterferon alfa-2a plus ribavirin, interferon alfa-2b plus ribavirin, and peginterferon alfa-2a alone in the initial treatment of chronic hepatitis C. METHODS\nA total of 1121 patients were randomly assigned to treatment and received at least one dose of study medication, consisting of 180 μg of peginterferon alfa-2a once weekly plus daily ribavirin (1000 or 1200 mg, depending on body weight), weekly peginterferon alfa-2a plus daily placebo, or 3 million units of interferon alfa-2b thrice weekly plus daily ribavirin for 48 weeks. RESULTS\nA significantly higher proportion of patients who received peginterferon alfa-2a plus ribavirin had a sustained virologic response (defined as the absence of detectable HCV RNA 24 weeks after cessation of therapy) than of patients who received interferon alfa-2b plus ribavirin (56 percent vs. 44 percent, P CONCLUSIONS\nIn patients with chronic hepatitis C, once-weekly peginterferon alfa-2a plus ribavirin was tolerated as well as interferon alfa-2b plus ribavirin and produced significant improvements in the rate of sustained virologic response, as compared with interferon alfa-2b plus ribavirin or peginterferon alfa-2a alone.


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