Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
- Registration Number
- NCT02996682
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF/VEL + RBV RBV SOF/VEL + RBV for 12 weeks SOF/VEL + RBV SOF/VEL SOF/VEL + RBV for 12 weeks SOF/VEL SOF/VEL SOF/VEL for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) 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 Up to 12 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in HCV RNA Baseline and up to 12 weeks Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score Baseline to Posttreatment Week 24 MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) Posttreatment Week 4 SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
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 Virologic failure was defined as:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement).Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) Posttreatment Week 24 SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class Baseline to Posttreatment Week 24 CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard.