A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis
Overview
- Phase
- Phase 3
- Intervention
- SOF/VEL
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 102
- 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 evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic HCV-infected males and non-pregnant/non-lactating females
- •Treatment naive or treatment experienced individuals
- •Child-Pugh-Turcotte Score 7-12 at screening
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
- Not provided
Arms & Interventions
SOF/VEL
SOF/VEL for 12 weeks
Intervention: SOF/VEL
SOF/VEL + RBV
SOF/VEL + RBV for 12 weeks
Intervention: SOF/VEL
SOF/VEL + RBV
SOF/VEL + RBV for 12 weeks
Intervention: RBV
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 Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event
Time Frame: Up to 12 weeks
Secondary Outcomes
- Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score(Baseline to Posttreatment Week 24)
- Change From Baseline in HCV RNA(Baseline and up to 12 weeks)
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment(Up to 12 weeks)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
- Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class(Baseline to Posttreatment Week 24)