Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency

• Status: Completed
• Trial end date: 2017-10-19
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

Criteria

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.