A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Overview
- Phase
- Phase 3
- Intervention
- SOF/VEL
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 117
- Primary Endpoint
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Genotype 1 or 2 HCV infection
- •Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
- •Previously treated with a DAA-containing regimen of at least 4 week duration
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
- Not provided
Arms & Interventions
SOF/VEL FDC + RBV 12 weeks
SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
Intervention: SOF/VEL
SOF/VEL FDC + RBV 12 weeks
SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
Intervention: RBV
SOF/VEL FDC + RBV 24 weeks
SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
Intervention: SOF/VEL
SOF/VEL FDC + RBV 24 weeks
SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
Intervention: RBV
Outcomes
Primary Outcomes
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 24 weeks
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.
Secondary Outcomes
- Percentage of Participants With HCV RNA < LLOQ at Week 12(Week 12)
- Percentage of Participants With HCV RNA < LLOQ at Week 16(Week 16)
- Percentage of Participants With HCV RNA < LLOQ at Week 8(Week 8)
- Percentage of Participants With HCV RNA < LLOQ at Week 10(Week 10)
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 3(Week 3)
- Percentage of Participants With HCV RNA < LLOQ at Week 4(Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 5(Week 5)
- Percentage of Participants With HCV RNA < LLOQ at Week 6(Week 6)
- Percentage of Participants With HCV RNA < LLOQ at Week 1(Week 1)
- Percentage of Participants With HCV RNA < LLOQ at Week 2(Week 2)
- Percentage of Participants With HCV RNA < LLOQ at Week 20(Week 20)
- Percentage of Participants With HCV RNA < LLOQ at Week 24(Week 24)
- Change From Baseline in HCV RNA at Week 1(Baseline; Week 1)
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Change From Baseline in HCV RNA at Week 3(Baseline; Week 3)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Change From Baseline in HCV RNA at Week 5(Baseline; Week 5)
- Change From Baseline in HCV RNA at Week 6(Baseline; Week 6)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Change From Baseline in HCV RNA at Week 10(Baseline; Week 10)
- Change From Baseline in HCV RNA at Week 12(Baseline; Week 12)
- Change From Baseline in HCV RNA at Week 16(Baseline; Week 16)
- Change From Baseline in HCV RNA at Week 20(Baseline; Week 20)
- Change From Baseline in HCV RNA at Week 24(Baseline; Week 24)
- Percentage of Participants With Overall Virologic Failure(Up to Posttreatment Week 24)