A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

简要总结

主要结局

次要结局

• The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12(12 weeks after the last planned dose of treatment)
• Time to achieve <LLOQ undetectable HCV RNA(up to 16 weeks)
• The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)(up to 16 weeks)
• The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug(4 weeks after the last planned dose of the study drug)
• The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)(48 weeks either after the last planned dose of study drug or after time of failure)
• The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)(up to 16 weeks)
• The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)(up to 20 weeks)
• The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug(24 weeks after the last planned dose of the study drug)
• The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure(48 weeks either after the last planned dose of study drug or after time of failure)