Phase 3
Completed N=37
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Source: ClinicalTrials.gov NCT04112303 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12) — 100.0 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
15citations · ~4 / year
Sofosbuvir-velpatasvir in adults with hepatitis C virus infection and compensated cirrhosis in Japan.
Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
Linked Publications
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Sofosbuvir-velpatasvir in adults with hepatitis C virus infection and compensated cirrhosis in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12) |
100.0 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug |
— | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4) |
100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24) |
100.0 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
— | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic HCV-infected males and non-pregnant/non-lactating females
- Treatment-naïve or treatment-experienced individuals
- Compensated cirrhosis at Screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04112303) 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.