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

1. ALT > 10 x the upper limit of normal (ULN)

2. AST > 10 x ULN

3. Direct bilirubin > 1.5 x ULN

4. Platelets < 150,000/μL

5. HbA1c > 7.5%

6. Creatinine clearance (CLcr) < 60 mL /min, as calculated by the Cockcroft-Gault
equation

7. Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.

8. Albumin < 3.1 g/dL

9. 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

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

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

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