Phase 2
Completed N=79
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
Source: ClinicalTrials.gov NCT02781571 ↗Enrolled (actual)
79
Serious AEs
3.8%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) — 96.2 percentage of participants
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) |
96.2 | — |
| PRIMARY Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event |
1.3 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4) |
97.5 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 2 |
40.5 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 4 |
85.9 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 8 |
98.7 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 12 |
100.0 | — |
| SECONDARY HCV RNA at Week 2 |
1.59 | — |
| SECONDARY HCV RNA at Week 4 |
1.23 | — |
| SECONDARY HCV RNA at Week 8 |
1.15 | — |
| SECONDARY HCV RNA at Week 12 |
1.15 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 2 |
-4.75 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 4 |
-5.13 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-5.20 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 12 |
-5.22 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
2.5 | — |
Eligibility Criteria
Key Inclusion Criteria
- History of chronic HCV infection (≥ 6 months)
- HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
- Liver transplant ≥ 3 months prior to screening
- Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis
Key Exclusion Criteria
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
- Co-infection with HIV or hepatitis B virus
- Known hypersensitivity to study medication,
- Use of any prohibited concomitant medications as within with window before the Day 1 visit.
- De novo or recurrent hepatocellular carcinoma posttransplant
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02781571). 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.