A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Lead Sponsor

Vertex Pharmaceuticals Incorporated

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•Males and females of non-childbearing potential
•Genotype 1 chronic hepatitis C
•Laboratory evidence of HCV infection for 6 months
•Histologic evidence of chronic hepatitis C
•Subjects who have a body mass index (BMI) of ≤35 kg/m² (BMI = weight in kg / height² in meters)
•Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus
•Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus

•Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
•Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin
•Subjects with 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 (NASH), or primary biliary cirrhosis
•Histologic evidence of hepatic cirrhosis

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