Phase 3
Completed N=220
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
Source: ClinicalTrials.gov NCT02639338 ↗Enrolled (actual)
220
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) — 96.4; 96.3 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
239citations · ~27 / year
Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.
Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.
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) |
96.4; 96.3 | <0.001 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event |
0; 0.9 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
97.3; 97.2; 96.4; 96.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment |
17.3; 10.1; 56.4; 50.9; 87.3; 85.2 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.06; -4.09; -4.60; -4.73; -4.84; -5.00 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
1.8; 1.8 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic genotype 3 HCV infection (≥ 6 months)
- Presence of cirrhosis
- 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 (NCT02639338) 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.