Peginterferon Alfa-2a plus Ribavirin for Chronic Hepatitis C Virus Infection
Michael W. Fried, M.D., Mitchell L. Shiffman, M.D., K. Rajender Reddy, M.D., Coleman Smith, M.D., George Marinos, M.D., Fernando L. Gonçales, Jr., M.D., Dieter Häussinger, M.D., Moises Diago, M.D., Giampiero Carosi, M.D., Daniel Dhumeaux, M.D., Antonio Craxi, M.D., Amy Lin, M.S., Joseph Hoffman, M.D., and Jian Yu, M.D., Ph.D.
Background Treatment with peginterferon alfa-2a alone producessignificantly higher sustained virologic responses than treatmentwith interferon alfa-2a alone in patients with chronic hepatitisC virus (HCV) infection. We compared the efficacy and safetyof peginterferon alfa-2a plus ribavirin, interferon alfa-2bplus ribavirin, and peginterferon alfa-2a alone in the initialtreatment of chronic hepatitis C.
Methods A total of 1121 patients were randomly assigned to treatmentand received at least one dose of study medication, consistingof 180 µg of peginterferon alfa-2a once weekly plus dailyribavirin (1000 or 1200 mg, depending on body weight), weeklypeginterferon alfa-2a plus daily placebo, or 3 million unitsof interferon alfa-2b thrice weekly plus daily ribavirin for48 weeks.
Results A significantly higher proportion of patients who receivedpeginterferon alfa-2a plus ribavirin had a sustained virologicresponse (defined as the absence of detectable HCV RNA 24 weeksafter cessation of therapy) than of patients who received interferonalfa-2b plus ribavirin (56 percent vs. 44 percent, P<0.001)or peginterferon alfa-2a alone (56 percent vs. 29 percent, P<0.001).The proportions of patients with HCV genotype 1 who had sustainedvirologic responses were 46 percent, 36 percent, and 21 percent,respectively, for the three regimens. Among patients with HCVgenotype 1 and high base-line levels of HCV RNA, the proportionsof those with sustained virologic responses were 41 percent,33 percent, and 13 percent, respectively. The overall safety profiles of the three treatment regimens were similar;the incidenceof influenza-like symptoms and depression was lower in the groupsreceiving peginterferon alfa-2a than in the group receivinginterferon alfa-2b plus ribavirin.
From the University of North Carolina, Chapel Hill (M.W.F.); the Medical College of Virginia, Richmond (M.L.S.); the University of Miami, Miami (K.R.R.); Minnesota Clinical Research Center, St. Paul (C.S.); Prince of Wales Hospital, Randwick, N.S.W., Australia (G.M.); Cidade Universitária Zeferino Vaz, Campinas, Brazil (F.L.G.); Heinrich-Heine-Universität, Düsseldorf, Germany (D.H.); General Universitario, Valencia, Spain (M.D.); Università degli Studi Brescia, Brescia, Italy (G.C.); Hôpital Henri Mondor, Creteil, France (D.D.); University of Palermo, Palermo, Italy (A.C.); and Hoffmann–LaRoche, Nutley, N.J. (J.H., A.L., J.Y.).
Address reprint requests to Dr. Fried at the University of North Carolina, CB# 7080, Rm. 708, Burnett Womack Bldg., Chapel Hill, NC 27599.
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