Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

Key Inclusion Criteria:

- HCV RNA > 15 IU/mL at screening

- HCV genotype 1 or 4

- Chronic HCV infection (≥ 6 months)

- Prior virologic failure after treatment with SOF in combination with simeprevir (SMV)
± RBV or with RBV ± pegylated interferon (PEG)

- Cirrhotic and non-cirrhotic as determined by standard methods

- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

- Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors

- Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF

- Pregnant or nursing female or male with pregnant female partner

- Coinfection with HIV or hepatitis B virus

- Current or prior history of clinical hepatic decompensation

- 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 individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.