VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

• The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
• The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug [ Time Frame: 24 weeks after the last planned dose of the study drug ] [ Designated as safety issue: No ]
• The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug [ Time Frame: 4 weeks after the last planned dose of the study drug ] [ Designated as safety issue: No ]
• The proportion of subjects who relapse (i.e., who had <LLOQ HCV RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT) [ Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]
• 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) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
• Time to achieve <LLOQ undetectable HCV RNA [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
• 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) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
• The association of the IL-28B genotype (CC versus CT versus TT) with SVR12 [ Time Frame: 12 weeks after the last planned dose of treatment ] [ Designated as safety issue: No ]
• The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure [ Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.

• Drug: VX-222
  400 mg tablets twice daily for oral administration
• Drug: telaprevir
  1125 mg tablets twice daily for oral administration
  Other Name: VX-950, INCIVEK, INCIVO, TELAVIC
• Drug: ribavirin
  1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
  Other Name: Copegus

• Experimental: 12 week treatment
  Interventions:

  • Drug: VX-222
  • Drug: telaprevir
  • Drug: ribavirin
• Experimental: 16 week treatment
  Interventions:

  • Drug: VX-222
  • Drug: telaprevir
  • Drug: ribavirin

Inclusion Criteria:

• Subjects must have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
• Subjects will be treatment naïve
• Subjects must have documentation of the presence or absence of cirrhosis

Exclusion Criteria:

• History or other clinical evidence of significant or unstable cardiac disease
• Evidence of hepatic decompensation
• Diagnosed or suspected hepatocellular carcinoma
• Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
• History of organ transplant, with the exception of corneal transplants and skin grafts