Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

• Status: Completed
• Trial end date: 2016-06-28
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Antiviral Agents; Ribavirin; Sofosbuvir; Velpatasvir

Criteria

Key Inclusion Criteria:

• Individuals with chronic HCV genotype 1 infection

• Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response

• Absence of cirrhosis or presence of compensated cirrhosis

• Screening laboratory values within defined thresholds

• Must use specific contraceptive methods if female of childbearing potential or sexually active male

Key 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 individual's treatment, assessment or compliance with the protocol

• Pregnant or a nursing female

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