Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.

Inclusion Criteria:

• Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
• Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
• HCV RNA > 10,000 IU/mL at Screening;
• Screening laboratory values within defined thresholds;
• Negative pregnancy test at baseline (females of childbearing potential only);
• Use of two effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

• Pregnant or nursing female;
• HIV infection or HBV infection (HBcAb and HBsAg positive);
• Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
• Active or recent history (≤ 1 year) of drug or alcohol abuse;
• Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).