Phase 3
Completed N=416
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
Source: ClinicalTrials.gov NCT02607735 ↗Enrolled (actual)
416
Serious AEs
3.2%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) — 96.2 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
557citations · ~62 / year
Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
Summary
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.
Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
Linked Publications (2)
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Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection.
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Deferred treatment with sofosbuvir-velpatasvir-voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study) |
96.2 | <0.001 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study) |
0.4; 2.0 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study) |
97.7; 0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study) |
15.6; 0; 56.7; 0; 92.7; 0 | — |
| SECONDARY Change From Baseline in HCV RNA (Primary Study) |
-4.20; 0.02; -4.81; 0.02; -5.07; -0.01 | — |
| SECONDARY Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study) |
96.2 | — |
| SECONDARY Percentage of Participants With Virologic Failure (Primary Study) |
2.7 | — |
| SECONDARY Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy) |
98.6; 97.3; 97.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy) |
14.3; 62.6; 93.2; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA (Deferred Treatment Substudy) |
-4.30; -4.93; -5.16; -5.20; -5.20 | — |
| SECONDARY Percentage of Participants With Virologic Failure (Deferred Treatment Substudy) |
2.7 | — |
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)
- Treatment experienced with a direct acting antiviral medication 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 (NCT02607735) 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.