Phase 3
Completed N=375
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Source: ClinicalTrials.gov NCT02671500 ↗Enrolled (actual)
375
Serious AEs
0.8%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 96.5; 96.2; 97.3 Percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
120citations · ~17 / year
Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial.
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) 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 treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
96.5; 96.2; 97.3 | <0.001 sig |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
97.1 | — |
| SECONDARY Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
96.5 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ On Treatment |
27.7; 73.8; 95.5; 99.7; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA |
-4.38; -4.89; -5.02; -5.03; -5.03; -5.03 | — |
| SECONDARY Percentage of Participants With Overall Virologic Failure |
3.2 | — |
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) documented by prior medical history or liver biopsy
- Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
- HCV treatment-naive or treatment-experienced
- Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
Key Exclusion Criteria
- Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non HCV etiology
- 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 (NCT02671500) 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.