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
Overview
- Phase
- Phase 3
- Intervention
- SOF/VEL/VOX
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 31
- Locations
- 27
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
- Status
- Completed
- Last Updated
- 7 years ago
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.
Investigators
Eligibility Criteria
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
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)