A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection
Overview
- Phase
- Phase 3
- Intervention
- SOF/VEL/VOX
- Conditions
- Hepatitis C
- Sponsor
- Gilead Sciences
- Enrollment
- 943
- 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 compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to provide written informed consent
- •HCV RNA ≥ 10\^4 IU/mL at screening
- •Chronic HCV infection (≥ 6 months)
- •HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
- •Use of protocol specified methods of contraception
Exclusion Criteria
- •Current or prior history of clinically significant illness that may interfere with participation in the study
- •Screening ECG with clinically significant abnormalities
- •Laboratory parameters outside the acceptable range at screening
- •Pregnant or nursing female
- •Chronic liver disease not caused by HCV
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
SOF/VEL/VOX
SOF/VEL/VOX tablet for 8 weeks
Intervention: SOF/VEL/VOX
SOF/VEL 12 weeks
SOF/VEL tablet for 12 weeks
Intervention: SOF/VEL
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) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
Time Frame: Up to 12 weeks
Secondary Outcomes
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ On Treatment(Weeks 1, 2, 4, 8, and 12)
- Change From Baseline in HCV RNA(Baseline; Weeks 1, 2, 4, 8, and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)