A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 87
- Locations
- 22
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
Study Overview
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic HCV infected males and non-pregnant/non-lactating females
- •Treatment-naive or treatment-experienced individuals
- •Non-cirrhosis or compensated cirrhosis at screening
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
- Not provided
Arms & Interventions
SOF/VEL
Participants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks.
Intervention: SOF/VEL (Drug)
SOF/VEL/VOX
Participants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks.
Intervention: SOF/VEL/VOX (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Time Frame: First dose date up to 12 weeks plus 30 days
Secondary Outcomes
- Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment(Posttreatment Week 4)
- Change From Baseline in HCV RNA(Baseline, Week 2, Week 4, Week 8, Week 12)
- Percentage of Participants With Virologic Failure(Baseline up to Posttreatment Week 12)
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Week 2, Week 4, Week 8, Week 12)
- Number of Participants With Alanine Aminotransferase (ALT) Normalization(Baseline, Week 2, Week 4, Week 8, Week 12)