SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir
 (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in
 treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus
 (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV
 infection.
Key Inclusion Criteria:

 -  Male or female, age greater than or equal to 18 years.

 -  Confirmed chronic HCV infection.

 -  Subjects will have cirrhosis status assessment; liver biopsy may be required.

 -  Genotype 2 subjects must have cirrhosis of the liver to be eligible.

 -  Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based
 regimen that was not discontinued prematurely due to an adverse event

 -  Infection with HCV genotype 2 or 3 as determined at Screening

 -  Body mass index (BMI) greater than or equal to 18 kg/m^2

 -  Screening laboratory values within predefined thresholds.

 -  Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in
 cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of
 intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.

 -  Subject must be of generally good health as determined by the Investigator.

 Key Exclusion Criteria:

 -  Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase

 -  Pregnant or nursing female or male with pregnant female partner

 -  History of any other clinically significant chronic liver disease.

 -  HIV or chronic hepatitis B virus (HBV) infection.

 -  Malignancy with the exception of certain resolved skin cancers.

 -  Chronic use of systemically administered immunosuppressive agents.

 -  Clinically-relevant drug or alcohol abuse.

 -  History of solid organ transplantation.

 -  Current or prior history of clinical hepatic decompensation.

 -  History of clinically-significant illness or any other major medical disorder that may
 interfere with subject treatment, assessment or compliance with the protocol.

 -  Known hypersensitivity to interferon, RBV, the study investigational medicinal
 product, the metabolites, or formulation excipients.

 Note: Other protocol defined Inclusion/Exclusion criteria may apply.