Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

Inclusion Criteria:

- Age ≥ 18, with chronic genotype 1 HCV infection

- HCV treatment-naive

- HCV RNA > 10,000 IU/mL at screening

- Cirrhosis determination; a liver biopsy may be required

- Screening laboratory values within defined thresholds

- Use of two effective contraception methods if female of childbearing potential or
sexually active male

Exclusion Criteria:

- Pregnant or nursing female or male with pregnant female partner

- Co-infection with HIV or hepatitis B virus (HBV)

- Current or prior history of clinical hepatic decompensation

- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
skin cancers)

- Chronic use of systemic immunosuppressive agents

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