Telaprevir + Peginterferon + Ribavirin for GT1 PROVE1 Study

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Presentation transcript:

Telaprevir + Peginterferon + Ribavirin for GT1 PROVE1 Study Phase 2b Treatment Naïve Telaprevir + Peginterferon + Ribavirin for GT1 PROVE1 Study McHutchison JG, et. al. N Engl J Med. 2009;360:1827-38.

Telaprevir for Treatment-Naïve HCV Genotype 1 PROVE1: Study Feature PROVE1: Study Features N = 236 randomized Randomized, double-blind, placebo-controlled Phase 2b trial Chronic HCV and treatment naïve All with Genotype 1 Age = 18-65; HIV negative; HBsAg negative Setting: 37 centers in United States Randomized to one of four treatment groups Drug Dosing Telaprevir = 1250 mg on day 1, then 750 mg every 8 hours Peginterferon alfa-2a = 180 µg weekly Ribavirin = 1000 mg/day for wt < 75 kg; 1200 mg/day for wt > 75 kg Source: McHutchison JG, et. al. N Engl J Med. 2009;360:1827-38.

Telaprevir for Treatment-Naïve HCV Genotype 1 PROVE1 Study: Treatment Regimens Week 12 24 48 N=17 T12 PR12 Telaprevir PEG + RBV N=79 T12 PR24 Telaprevir PEG + RBV N=79 T12 PR48 Telaprevir PEG + RBV N=75 PR48 Placebo PEG + RBV Source: McHutchison JG, et. al. N Engl J Med. 2009;360:1827-38.

Telaprevir for Treatment-Naïve HCV Genotype 1 PROVE1 Study: Results PROVE1: SVR24 by Regimen SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin Source: McHutchison JG, et. al. N Engl J Med. 2009;360:1827-38.

Telaprevir for Treatment-Naïve HCV Genotype 1 PROVE1 Study: Results PROVE1: Percentage of Patients with Relapse by Regimen T = Telaprevir; PR = Peginterferon + Ribavirin Source: McHutchison JG, et. al. N Engl J Med. 2009;360:1827-38.

Telaprevir for Treatment-Naïve HCV Genotype 1 PROVE1 Study: Results PROVE1: Patients with SVR24 and Relapse by Regimen SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin Source: McHutchison JG, et. al. N Engl J Med. 2009;360:1827-38.

Telaprevir for Treatment-Naïve HCV Genotype 1 PROVE1 Study: Conclusions 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.” Source:McHutchison JG, et. al. N Engl J Med. 2009;360:1827-38.