FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Published at www.nejm.org July 22, 2009 (10.1056/NEJMoa0808010)

	Full Text PDF Supplementary Material Purchase this article Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared.

Methods At 118 sites, patients who had HCV genotype 1 infection and who had not previously been treated were randomly assigned to undergo 48 weeks of treatment with one of three regimens: peginterferon alfa-2b at a standard dose of 1.5 µg per kilogram of body weight per week or a low dose of 1.0 µg per kilogram per week, plus ribavirin at a dose of 800 to 1400 mg per day, or peginterferon alfa-2a at a dose of 180 µg per week plus ribavirin at a dose of 1000 to 1200 mg per day. We compared the rate of sustained virologic response and the safety and adverse-event profiles between the peginterferon alfa-2b regimens and between the standard-dose peginterferon alfa-2b regimen and the peginterferon alfa-2a regimen.

Results Among 3070 patients, rates of sustained virologic response were similar among the regimens: 39.8% with standard-dose peginterferon alfa-2b, 38.0% with low-dose peginterferon alfa-2b, and 40.9% with peginterferon alfa-2a (P=0.20 for standard-dose vs. low-dose peginterferon alfa-2b; P=0.57 for standard-dose peginterferon alfa-2b vs. peginterferon alfa-2a). Estimated differences in response rates were 1.8% (95% confidence interval [CI], –2.3 to 6.0) between standard-dose and low-dose peginterferon alfa-2b and –1.1% (95% CI, –5.3 to 3.0) between standard-dose peginterferon alfa-2b and peginterferon alfa-2a. Relapse rates were 23.5% (95% CI, 19.9 to 27.2) for standard-dose peginterferon alfa-2b, 20.0% (95% CI, 16.4 to 23.6) for low-dose peginterferon alfa-2b, and 31.5% (95% CI, 27.9 to 35.2) for peginterferon alfa-2a. The safety profile was similar among the three groups; serious adverse events were observed in 8.6 to 11.7% of patients. Among the patients with undetectable HCV RNA levels at treatment weeks 4 and 12, a sustained virologic response was achieved in 86.2% and 78.7%, respectively.

Conclusions In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon–ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials.gov number, NCT00081770 [ClinicalTrials.gov] .)

Source Information

From the Duke Clinical Research Institute and Duke University Medical Center, Durham, NC (J.G.M., A.J.M.); Alamo Medical Research, San Antonio, TX (E.J.L.); Kelsey Research Foundation, Houston (G.W.G.); University of Texas Southwestern Medical Center, Dallas (W.M.L.); the Liver Institute at Methodist Dallas Medical Center, Dallas (R.H.G.); and Liver Specialists of Texas, Houston (J.S.G.); Virginia Commonwealth University, Richmond (M.L.S.); and Mount Vernon Endoscopy Center, Alexandria, VA (J.M.); Kaiser Permanente, San Diego Medical Center, San Diego, CA (L.M.N.); University of Miami Center for Liver Diseases, Miami (E.R.S.); and South Florida Center of Gastroenterology, Wellington (M.N.D.); Saint Louis University School of Medicine, St. Louis (B.R.B.); Schering-Plough Research Institute, Kenilworth, NJ (P.M., K.K., S.N., L.D.P., C.A.B., J.K.A.), and Johns Hopkins University School of Medicine, Baltimore (M.S.S.).

This article (10.1056/NEJMoa0808010) was published on July 22, 2009, at NEJM.org.

Address reprint requests to Dr. McHutchison at Duke Clinical Research Institute, Duke University Medical Center, P.O. Box 17969, Durham, NC 27715, or at mchut001{at}mc.duke.edu.

Full Text of this Article

This article has been cited by other articles:

• Hsu, C.-S., Kao, J.-H., Albrecht, J., McHutchison, J., Sulkowski, M. (2009). Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Hepatitis C. NEJM 361: 1808-1809 [Full Text]  
• (2009). Peginterferon Regimens for Treating HCV Infection: Alfa-2a vs. Alfa-2b. JWatch Infect. Diseases 2009: 2-2 [Full Text]