A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
Overview
- Phase
- Phase 2
- Intervention
- SOF/VEL/VOX
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
SOF/VEL/VOX
SOF/VEL/VOX for 12 weeks
Intervention: SOF/VEL/VOX
SOF/VEL/VOX + RBV
SOF/VEL/VOX + RBV for 12 weeks
Intervention: SOF/VEL/VOX
SOF/VEL/VOX + RBV
SOF/VEL/VOX + RBV for 12 weeks
Intervention: RBV
Outcomes
Primary Outcomes
Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
Time Frame: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)
Time Frame: Posttreatment Week 12
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Secondary Outcomes
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Weeks 1, 2, 4, 8 and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- HCV RNA Change From Baseline/Day 1 Through Week 12(Weeks 1, 2, 4, 8, and 12)