Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1

Starting on Day 1 and for up to 12 weeks, you will receive Telaprevir (TVR) and Sofosbuvir (SOF).

You will take one (1) 400 mg tablet of SOF and 3 tablets (1125 mg each) of TVR. You should take these together by mouth every morning. You will take another 3 tablets (1125 mg each) of TVR by mouth 12 hours after you take your morning dose.

Inclusion criteria

• Willing and able to provide informed consent
• BMI (Body Mass Index) ≥ 18 kg/m2
• HCV RNA quantifiable at screening and >1,000 IU/ml
• HCV treatment Naïve
• HCV genotype 1
• 7. Confirmation of chronic HCV infection documented by either: A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection

Exclusion criteria

• Current or prior history of any of the following:

Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant abnormalities

• ALT > 10 x the upper limit of normal (ULN)
• AST > 10 x ULN
• Direct bilirubin > 1.5 x ULN
• Platelets < 150,000/μL
• HbA1c > 7.5%
• Creatinine clearance (CLcr) < 60 mL /min, as calculated by the Cockcroft-Gault equation
• Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.
• Albumin < 3.1 g/dL
• INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 4. Prior exposure to any approved or experimental HCV-specific direct-acting

• Pregnant or nursing female or male with pregnant female partner.

• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).