Phase 2
Completed N=205
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Source: ClinicalTrials.gov NCT02378935 ↗Enrolled (actual)
205
Serious AEs
1.0%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 70.6; 100.0; 93.9; 80.6 percentage of participants
Summary
This 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) ± ribavirin (RBV) in adults with chronic 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) |
70.6; 100.0; 93.9; 80.6; 100; 100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 0; 0; 6.5; 0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
88.2; 100.0; 93.9; 87.1; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
23.5; 38.9; 33.3; 16.1; 22.6; 28.1 | — |
| SECONDARY HCV RNA Change From Baseline |
-4.64; -4.60; -4.15; -4.31; -4.40; -4.19 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
29.4; 0; 6.1; 19.4; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Individuals with chronic HCV infection
- HCV RNA ≥10^4 IU/mL at screening
- HCV genotype 1
- 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 (NCT02378935). 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.