Phase 3
Completed N=943
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
Source: ClinicalTrials.gov NCT02607800 ↗Enrolled (actual)
943
Serious AEs
2.3%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 95.2; 98.2 percentage of participants
◆ Published Evidence
Highly cited
238citations · ~26 / year
Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.
Linked Publications
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Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
95.2; 98.2 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event |
0; 0.5 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
96.4; 98.9; 95.0; 98.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment |
24.8; 22.7; 65.9; 61.3; 92.4; 92.0 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.23; -4.24; -4.75; -4.77; -4.95; -4.99 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
4.2; 0.7 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months)
- HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
- Use of protocol specified methods of contraception
Key Exclusion Criteria
- Current or prior history of clinically significant illness that may interfere with participation in the study
- Screening ECG with clinically significant abnormalities
- Laboratory parameters outside the acceptable range at screening
- Pregnant or nursing female
- Chronic liver disease not caused by HCV
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02607800) and the linked publication. 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.