An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 31
- Locations
- 27
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Study Overview
Brief Summary
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
- Not provided
Arms & Interventions
SOF/VEL/VOX
SOF/VEL/VOX for 12 weeks
Intervention: SOF/VEL/VOX (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to Week 12
Secondary Outcomes
- Percentage of Participants With HCV RNA < LLOQ On Treatment(Weeks 2, 4, 8, and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Change From Baseline in HCV RNA(Baseline; Weeks 2, 4, 8, and 12)