Phase 3
Completed N=333
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Source: ClinicalTrials.gov NCT02639247 ↗Enrolled (actual)
333
Serious AEs
2.4%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 97.8; 90.1 percentage of participants
◆ Published Evidence
Highly cited
565citations · ~63 / year
Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
Summary
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.
Linked Publications
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Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
97.8; 90.1 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event |
0; 0.7 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
98.4; 91.4; 97.8; 90.1 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment |
15.9; 17.2; 62.6; 56.3; 88.5; 90.7 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.29; -4.17; -4.93; -4.78; -5.13; -5.06 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0.5; 9.9 | — |
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)
- Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV
- 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 results outside of acceptable ranges 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 (NCT02639247) 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.