Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir
 (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and
 to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in
 participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic
 renal insufficiency (impaired kidney function).
Key Inclusion Criteria:

 -  Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection

 -  Cohort 3: chronic genotype 1 or 4 HCV infection

 -  HCV RNA ≥ 10^4 IU/mL at screening

 -  Screening labs within defined thresholds

 -  Cirrhosis determination at screening

 Key Exclusion Criteria:

 -  Females who are pregnant or nursing or males who have a pregnant partner

 -  Prior null response to pegylated interferon (Peg-IFN)+RBV therapy (Cohorts 1 and 2) or
 for individuals with cirrhosis, prior treatment failure with IFN-based therapy not
 resulting from treatment intolerance (Cohort 3)

 -  Current of prior history of hepatic decompensation

 -  Infection with hepatitis B virus (HBV) or HIV

 -  History of clinically significant illness (including psychiatric or cardiac) or any
 other medical disorder that may interfere with individual's treatment and/or adherence
 to the protocol

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