Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

IND numbers: 79,599; 101,943

Inclusion Criteria:

- Men and women, ages ≥18 years of age

- Subjects who are naive to HCV treatment, defined as no previous exposure to an
Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or
experimental therapy or subjects who are null responders to previous pegylated
Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment

- Subjects should have chronic hepatitis C (CHC) as documented by:

1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at
least 6 months prior to screening, and positive for HCV RNA and Anti-HCV
antibody at the time of screening, or

2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver
biopsy consistent with chronic HCV infection (or a liver biopsy performed prior
to enrollment with evidence of CHC disease, such as the presence of fibrosis)

- HCV genotype 1a, 1b or 4 only

- HCV RNA viral load of ≥10,000 IU/mL at screening

- Have one of the following:

1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to
platelet ratio index (APRI) ≤2; OR

2. Documented liver biopsy within 36 months preceding Day 1 showing absence of
cirrhosis OR

3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening
showing absence of cirrhosis

- Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive

- Subjects with compensated Child-Pugh A cirrhosis as documented by history of
cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved)
within 12 months prior to screening

Exclusion Criteria:

- Evidence of a medical condition associated with chronic liver disease other than HCV
(such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver
disease, alcoholic liver disease, toxin exposures)

- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management
with diuretics or paracentesis

- Current or known history of cancer (except in situ carcinoma of the cervix or
adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
to enrollment

- Documented or suspected hepatocellular carcinoma (HCC)

- Positive for hepatitis B surface antigen (HBsAg)

- Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency
Virus-2 (HIV-2) antibodies

- Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN)

- Total Bilirubin ≥2 mg/dL