Phase 3
N=102
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
Hepatitis C Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT02996682 ↗Enrolled (actual)
102
Serious AEs
10.8%
Results posted
Feb 2019
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 92.2; 92.2 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SOF/VEL (Drug); RBV (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
92.2; 92.2 | <0.001 sig |
| PRIMARY Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event |
0; 3.9; NA; 17.6 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
94.1; 96.1 | — |
| SECONDARY Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
92.2; 92.2 | — |
| SECONDARY Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment |
45.1; 51.0; 96.1; 90.2; 100.0; 96.1 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.14; -4.33; -4.55; -4.65; -4.56; -4.70 | — |
| SECONDARY Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score |
38.3; 21.7; 53.2; 54.3; 8.5; 23.9 | — |
| SECONDARY Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class |
36.2; 39.1; 4.3; 2.2 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
7.8; 3.9 | — |
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.
Eligibility Criteria
Key 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.
Data sourced from ClinicalTrials.gov (NCT02996682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.