Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02226549

GS-US-337-1512

Details and patient eligibility

About

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years, with chronic HCV genotype 1 infection
• Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
• Presence of compensated cirrhosis
• Screening laboratory values within defined thresholds
• Must use specific contraceptive methods if female of childbearing potential or sexually active male
• Not pregnant or a nursing female

Exclusion criteria

• Co-infection with HIV or hepatitis B virus (HBV)
• Current or prior history of clinical hepatic decompensation
• Chronic use of systemic immunosuppressive agents
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

LDV/SOF+VDV

Experimental group

Description:

Participants will receive LDV/SOF+VDV for 8 weeks.

Treatment:

Drug: VDV

Drug: LDV/SOF

LDV/SOF+VDV+RBV

Experimental group

Description:

Participants will receive LDV/SOF+VDV+RBV for 8 weeks.

Treatment:

Drug: VDV

Drug: RBV

Drug: LDV/SOF