Phase 3
Completed N=87
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Source: ClinicalTrials.gov NCT04211909 ↗Enrolled (actual)
87
Serious AEs
4.6%
Results posted
Oct 2021
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment — 98.1; 100 percentage of participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
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 Study Treatment |
98.1; 100 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event |
1.9; 0 | — |
| SECONDARY Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment |
98.1; 100 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
1.9; 0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
90.6; 69.7; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA |
5.95; 6.48; -4.78; -5.19; -4.81; -5.33 | — |
| SECONDARY Number of Participants With Alanine Aminotransferase (ALT) Normalization |
21; 16; 21; 13; 21; 13 | — |
Eligibility Criteria
Key Inclusion Criteria
- Chronic HCV infected males and non-pregnant/non-lactating females
- Treatment-naive or treatment-experienced individuals
- Non-cirrhosis or compensated cirrhosis at screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04211909). 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.