Phase 2
Completed N=128
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Source: ClinicalTrials.gov NCT02378961 ↗Enrolled (actual)
128
Serious AEs
0.8%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 87.9; 93.3; 100.0; 96.6 percentage of participants
Summary
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
87.9; 93.3; 100.0; 96.6 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 6.7; 0; 3.4 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
90.9; 96.7; 100.0; 100.0; 87.9; 93.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
33.3; 20.0; 33.3; 10.; 81.8; 73.3 | — |
| SECONDARY HCV RNA Change From Baseline |
-4.51; -4.28; -4.51; -4.24; -4.91; -4.84 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
12.1; 6.7; 0; 3.4 | — |
Eligibility Criteria
Key Inclusion Criteria
- Individuals with chronic HCV infection
- HCV RNA ≥10^4 IU/mL at screening
- HCV genotypes 2, 3, 4, 5, or 6
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria
- Pregnant or nursing female
- Current or prior history of hepatic decompensation
- Hepatocellular carcinoma (HCC) or other clinically significant malignancy
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02378961). 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.