Phase 2
Completed N=9
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
Source: ClinicalTrials.gov NCT02728206 ↗Enrolled (actual)
9
Serious AEs
55.6%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 77.8 Percentage of participants
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) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
77.8 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
11.1 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
88.9 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment |
0; 0; 0; 33.3; 85.7; 85.7 | — |
| SECONDARY Percentage of Participants With Overall Virologic Failure |
— | — |
Eligibility Criteria
Key Inclusion Criteria
- HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver transplantation
Key Exclusion Criteria
- Receiving an HCV-infected liver
- HIV or hepatitis B virus (HBV) co-infected
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02728206). 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. Informational only — not medical advice.