Impact of weight-based ribavirin with peginterferon alfa-2b in african americans with hepatitis C virus genotype 1§

Authors


  • Trial registration number NCT00299936, available at: http://clinicaltrials.gov

  • Potential conflict of interest: Ira M. Jacobson, Schering-Plough consultant, speaker bureau, research support; Merck consultant, GlobeImmune consultant, research support, Human Genome Sciences consultant, research support; Coley consultant, research support; Gilead consultant, speaker bureau, research support; Vertex consultant, research support; Intermune consultant, research support; Intarcia consultant; Valeant consultant, research support; GlaxoSmithKline consultant; Idenix consultant, speaker bureau, research support; Novartis consultant, speaker bureau, research support; Bristol-Myers Squibb consultant, speaker bureau; Boehringer Ingelheim consultant; XTL consultant. Robert S. Brown, Schering-Plough consultant, research support, honoraria; Jonathan McCone, Schering-Plough speaker bureau, grant support; Roche speaker bureau; Martin Black, Schering-Plough speaker bureau, Roche speaker bureau, Valeant speaker bureau, Bristol-Myers Squibb speaker bureau, Gilead speaker bureau, GlaxoSmithKline speaker bureau, Axcan speaker bureau; Clive Albert, Wyeth speaker bureau, AstraZeneca speaker bureau; Paul Y. Kwo, Schering-Plough research support; Greg W. Galler, Schering-Plough consultant, speakers bureau, advisor, grant support; Roche consultant, speakers bureau, advisor, grant support; Victor Araya, Schering-Plough speakers bureau, grant support, Roche speakers bureau, grant support, Gilead speakers bureau; Bradley Freilich, Schering-Plough speaker bureau, research support; Joann Harvey, Schering-Plough consultant; Louis H. Griffel, Schering-Plough employee; Clifford A. Brass, Schering-Plough employee.

  • §

    See Editorial on Page 953

Abstract

WIN-R (Weight-based dosing of pegINterferon alfa-2b and Ribavirin) was a multicenter, randomized, open-label, investigator-initiated trial involving 236 community and academic sites in the United States, comparing response to pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in treatment-naive patients with chronic hepatitis C and compensated liver disease. Patients were randomized to receive PEG-IFN alfa-2b at 1.5 μg/kg/week plus flat-dose (800 mg/day) or weight-based-dose RBV (800 mg/day for weight <65 kg, 1000 mg/day for 65-85 kg, 1200 mg/day for >85-105 kg, or 1400 mg/day for >105-<125 kg). Sustained virologic response (SVR; undetectable [<125 IU/mL] hepatitis C virus [HCV] RNA at end of follow-up) in patients ≥65 kg was the primary end point. Low SVR rates have been reported among African American individuals, in whom there is a preponderance of HCV genotype 1. This subanalysis of WIN-R was conducted to evaluate the efficacy of weight-based dosing among African American individuals with genotype 1 infection enrolled in the trial. Of 362 African American patients in the primary efficacy analysis, 188 received RBV flat dosing and 174 received weight-based dosing. SVR rates were higher (21% versus 10%; P = 0.0006) and relapse rates were lower (22% versus 30%) in the weight-based-dose group than in the flat-dose group. Safety and rates of drug discontinuation were similar between the 2 groups. Conclusion: Weight-based dosing of RBV is more effective than flat dosing in combination with PEG-IFN alfa-2b in African American individuals with HCV genotype 1. Even with weight-based dosing, response rates in African American individuals are lower than reported in other ethnic groups. (HEPATOLOGY 2007.)

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