Phase 3
Completed N=119
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
Source: ClinicalTrials.gov NCT02722837 ↗Enrolled (actual)
119
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) — 99.2 percentage of participants
◆ Published Evidence
Emerging
15citations · ~2 / year
Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden.
Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
Linked Publications
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Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
99.2 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) |
99.2 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 |
21.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 |
64.7 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 |
96.6 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 |
100.0 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 1 |
-4.17 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 2 |
-4.70 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 4 |
-4.90 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-4.93 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 12 |
-4.93 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0.8 | — |
Eligibility Criteria
Key Inclusion Criteria
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Key Exclusion Criteria
- Any other chronic liver disease
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Clinical hepatic decompensation
- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02722837) 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.