Overview

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.