Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
 of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in
 treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C
 virus (HCV) infection.
Key Inclusion Criteria:

 -  Willing and able to provide written informed consent

 -  HCV RNA ≥ 10^4 IU/mL at screening

 -  HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other
 approved or experimental HCV-specific direct-acting antiviral agent; OR HCV
 treatment-experienced with medical records that include sufficient detail of prior
 IFN-based treatment to allow for categorization of prior response as either
 intolerant, non-responder, or experienced viral breakthrough or relapse.

 -  Genotype 1 HCV at screening

 -  HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

 Key Exclusion Criteria:

 -  Pregnant or nursing female

 -  Chronic liver disease of a non-HCV etiology

 -  Current or prior history of any clinically-significant illness (other than HCV)

 -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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