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A correction has been published: N Engl J Med 2009;361(15):1516.
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Background Current therapy for chronic hepatitis C virus (HCV) infection is effective in less than 50% of patients infected with HCV genotype 1. Telaprevir, a protease inhibitor specific to the HCV nonstructural 3/4A serine protease, rapidly reduced HCV RNA levels in early studies.
Methods We randomly assigned patients infected with HCV genotype 1 to one of three telaprevir groups or to the control group. The control group (called the PR48 group) received peginterferon alfa-2a (180 µg per week) and ribavirin (1000 or 1200 mg per day, according to body weight) for 48 weeks, plus telaprevir-matched placebo for the first 12 weeks (75 patients). The telaprevir groups received telaprevir (1250 mg on day 1 and 750 mg every 8 hours thereafter) for 12 weeks, as well as peginterferon alfa-2a and ribavirin (at the same doses as in the PR48 group) for the same 12 weeks (the T12PR12 group, 17 patients) or for a total of 24 weeks (the T12PR24 group, 79 patients) or 48 weeks (the T12PR48 group, 79 patients). The primary outcome was a sustained virologic response (an undetectable HCV RNA level 24 weeks after the end of therapy).
Results The rate of sustained virologic response was 41% (31 of 75 patients) in the PR48 group, as compared with 61% (48 of 79 patients) in the T12PR24 group (P=0.02), 67% (53 of 79 patients) in the T12PR48 group (P=0.002), and 35% (6 of 17 patients) in the T12PR12 group (this group was exploratory and not compared with the control group). Viral breakthrough occurred in 7% of patients receiving telaprevir. The rate of discontinuation because of adverse events was higher in the three telaprevir-based groups (21%, vs. 11% in the PR48 group), with rash the most common reason for discontinuation.
Conclusions Treatment with a telaprevir-based regimen significantly improved sustained virologic response rates in patients with genotype 1 HCV, albeit with higher rates of discontinuation because of adverse events. (ClinicalTrials.gov number, NCT00336479
[ClinicalTrials.gov]
.)
Source Information
From the Duke Clinical Research Institute and Duke University, Durham, NC (J.G.M., A.J.M.); the Division of Gastroenterology and Hepatology, University of Colorado Health Science Center, Denver (G.T.E.); Division of Hepatology, Henry Ford Hospital, Detroit (S.C.G.); Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York (I.M.J.); Johns Hopkins University, Baltimore (M.S.); and Vertex Pharmaceuticals, Cambridge, MA (R.K., L.M., J.A.).
This article (10.1056/NEJMoa0806104) was updated on October 7, 2009, at NEJM.org.
Address reprint requests to Dr. McHutchison at the Duke Clinical Research Institute, Duke University Medical Center, P.O. Box 17969, Durham, NC 27715, or at mchut001{at}mc.duke.edu.
Related Letters:
Telaprevir for Chronic HCV Infection
van der Meer A. J.P., de Knegt R. J., Kao J.-H., McHutchison J., Pawlotsky J.-M., Zeuzem S., the PROVE1 and PROVE2 Study Teams
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N Engl J Med 2009;
361:533-535, Jul 30, 2009.
Correspondence
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