Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: RBV; Drug: SOF/VEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02822794

GS-US-342-3921

Details and patient eligibility

About

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

Enrollment: 117 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Genotype 1 or 2 HCV infection
• Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
• Previously treated with a DAA-containing regimen of at least 4 week duration

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

117 participants in 2 patient groups

SOF/VEL FDC + RBV 12 weeks

Experimental group

Description:

SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection

Treatment:

Drug: SOF/VEL

Drug: RBV

SOF/VEL FDC + RBV 24 weeks

Experimental group

Description:

SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection

Treatment:

Drug: SOF/VEL

Drug: RBV