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

• Status: Completed
• Trial end date: 2017-10-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ribavirin; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

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.