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 is an interventional treatment trial for Hepatitis C focused on measuring 7977, GS-7977, PSI-7977, Sofosbuvir (SOF), Pegylated Interferon (Peg-IFN), Ribavirin (RBV) Read More

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.