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
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: SOF; RBV; Peg-IFN
Intervention description: 400 mg tablet administered orally once daily; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); 180 µg administered via subcutaneous injection once weekly
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 7977; GS-7977; PSI-7977; Sofosbuvir (SOF); Pegylated Interferon (Peg-IFN); Ribavirin (RBV)

Summary:

      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.
    

Eligibility criteria:

        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.