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
Overview
- Phase
- Phase 3
- Intervention
- SOF/VEL
- Conditions
- Hepatitis C Virus Infection
- 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
- Status
- Completed
- Last Updated
- 4 years ago
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.
Investigators
Eligibility Criteria
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
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
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)