Phase 1
Completed N=101
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Source: ClinicalTrials.gov NCT02185794 ↗Enrolled (actual)
101
Serious AEs
1.1%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants Experiencing Treatment Emergent Adverse Events — 25.0; 14.3; 16.7; 13.3 percentage of participants
Summary
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment Emergent Adverse Events |
25.0; 14.3; 16.7; 13.3; 33.3; 12.5 | — |
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities |
37.5; 28.6; 26.7; 20.0; 50.0; 62.5 | — |
| PRIMARY Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA |
-0.12; -3.81; -3.97; -3.33; -0.24; -1.47 | — |
| SECONDARY Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48 |
6.73; 6.30; 6.35; 6.05; 6.11; 5.61 | — |
| SECONDARY Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND) |
0; 0; 1; 1; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic genotype 1-4 HCV infection
- For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria
- Pregnant or nursing female or male with pregnant female partner
- Presence of cirrhosis
- Prior exposure to approved or experimental HCV Protease Inhibitors
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02185794). 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.