Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

Inclusion Criteria: * Age equal to or greater than 18 years, with chronic genotype 1 HCV infection * HCV RNA ≥ 10,000 IU/mL at screening * Prior virological failure after treatment with pegylated interferon (PEG-IFN), RBV and a protease inhibitor following documented prior virology failure after treatment with a PEG-IFN + RBV regimen * Evidence of cirrhosis * 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 * Current or prior history of clinical hepatic decompensation * Prior exposure to approved or experimental HCV specific direct-acting antivirals other than a nonstructural protein (NS)3/4A protease inhibitor * History of solid organ transplantation, including liver transplant * Hepatocellular carcinoma 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