VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

This is an interventional treatment trial for Genotype 1 Chronic Hepatitis C focused on measuring Genotype 1 chronic hepatitis C, VX-950-C211, VX-950, IL28B, Telaprevir, Hepatitis C, BID, Q8h, SOC Read More

Inclusion Criteria:

• Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
• Patients should not have had any previous treatment for hepatitis C
• Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
• Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
• A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

• Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
• Patient has a pre-existing psychiatric condition
• Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
• Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
• Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).