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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: HCV Infection

Treatments: Drug: LDV/SOF; Drug: SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01958281

GS-US-334-0154

2013-002897-30 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

SOF 200 mg + RBV 200 mg (Cohort 1)

Experimental group

Description:

Participants with genotype 1 or 3 HCV infection will receive SOF 200 mg (2 × 100 mg tablets) plus RBV once daily for 24 weeks.

Treatment:

Drug: SOF

Drug: RBV

SOF 400 mg + RBV 200 mg (Cohort 2)

Experimental group

Description:

Participants with genotype 1 or 3 HCV infection will receive SOF 400 mg (4 × 100 mg tablets or 1 × 400 mg tablet) plus RBV once daily for 24 weeks.

Treatment:

Drug: SOF

Drug: RBV

LDV/SOF (Cohort 3)

Experimental group

Description:

Participants with genotype 1 or 4 HCV infection will receive LDV/SOF once daily for 12 weeks.

Treatment:

Drug: LDV/SOF