Phase 3
Completed N=117
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Source: ClinicalTrials.gov NCT02822794 ↗Enrolled (actual)
117
Serious AEs
3.4%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 85.1; 70.0; 97.9; 91.7 percentage of participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
85.1; 70.0; 97.9; 91.7 | <0.001 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
1.8; 3.3 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
86.0; 98.3 | — |
| SECONDARY Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
82.5; 96.7 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 1 |
21.1; 25.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 2 |
64.3; 70.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 3 |
91.1; 90.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 4 |
98.2; 98.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 5 |
98.2; 98.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 6 |
100.0; 98.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 8 |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 10 |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 12 |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 16 |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 20 |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 24 |
100.0 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 1 |
-4.40; -4.36 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 2 |
-4.91; -4.89 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 3 |
-5.07; -5.02 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 4 |
-5.12; -5.04 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 5 |
-5.13; -5.05 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 6 |
-5.13; -5.05 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-5.13; -5.06 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 10 |
-5.13; -5.06 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 12 |
-5.13; -5.06 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 16 |
-5.06 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 20 |
-5.06 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 24 |
-5.06 | — |
| SECONDARY Percentage of Participants With Overall Virologic Failure |
15.8; 3.3 | — |
Eligibility Criteria
Key Inclusion Criteria
- Genotype 1 or 2 HCV infection
- Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
- Previously treated with a DAA-containing regimen of at least 4 week duration
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02822794). 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.