Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: RBV; Drug: SOF/VEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02781558

GS-US-342-2097

2016-000417-73 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Willing and able to provide written informed consent
• Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
• Individuals with or without HIV-1 coinfection

Key Exclusion Criteria:

• History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
• Co-infection with active hepatitis B virus
• Laboratory results outside the acceptable ranges at screening
• Pregnant or nursing female
• Chronic liver disease not caused by HCV

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

SOF/VEL

Experimental group

Description:

SOF/VEL FDC for 12 weeks

Treatment:

Drug: SOF/VEL

SOF/VEL + RBV

Experimental group

Description:

SOF/VEL FDC + RBV for 12 weeks

Treatment:

Drug: RBV

Drug: SOF/VEL