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
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
The purpose of this study is to estimate the rate of sustained virologic response (SVR)
 SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks
 post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1)
 infected patients who are prior null responders to pegIFN/ribavirin
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