Phase 3
Completed N=31
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Source: ClinicalTrials.gov NCT03118843 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 100.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment |
51.6; 96.8; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
— | — |
| SECONDARY Change From Baseline in HCV RNA |
-5.16; -5.34; -5.34; -5.34 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03118843). 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.