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

• Status: Completed
• Trial end date: 2016-07-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Interferons; Ribavirin; Sofosbuvir

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.