Articulo De Hepatitis

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n e w e ng l a n d j o u r na l

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m e dic i n e

original article

Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection
John G. McHutchison, M.D., Eric J. Lawitz, M.D., Mitchell L. Shiffman, M.D., Andrew J. Muir, M.D., Greg W. Galler, M.D., Jonathan McCone, M.D., Lisa M. Nyberg, M.D., William M. Lee, M.D., Reem H. Ghalib, M.D., Eugene R.Schiff, M.D., Joseph S. Galati, M.D., Bruce R. Bacon, M.D., Mitchell N. Davis, M.D., Pabak Mukhopadhyay, Ph.D., Kenneth Koury, Ph.D., Stephanie Noviello, M.D., Lisa D. Pedicone, Ph.D., Clifford A. Brass, M.D., Janice K. Albrecht, Ph.D., and Mark S. Sulkowski, M.D., for the IDEAL Study Team*

A BS T R AC T
Background
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.); ScheringPlough Research Institute, Kenilworth, NJ (P.M., K.K., S.N., L.D.P., C.A.B., J.K.A.), and Johns HopkinsUniversity School of Medicine, Baltimore (M.S.S.). 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@mc.duke.edu. *Additional members of the Individualized Dosing Efficacy vs. Flat Dosing to Assess Optimal Pegylated Interferon Therapy (IDEAL) study team are listed in the Appendix. This article(10.1056/NEJMoa0808010) was published on July 22, 2009, at NEJM.org. N Engl J Med 2009;361:580-93.
Copyright © 2009 Massachusetts Medical Society.

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 118sites, 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 μgper 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 alfa2b regimen and the peginterferon alfa-2a regimen.
Results

Among 3070 patients, rates of sustained virologic response were similar among theregimens: 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 standarddose 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-dosepeginterferon 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 lowdose peginterferon alfa-2b, and 31.5% (95% CI, 27.9 to 35.2) for peginterferon alfa2a. The safety profile was similar among the three groups; serious...