Phase 2
Completed N=204
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
Source: ClinicalTrials.gov NCT02781558 ↗Enrolled (actual)
204
Serious AEs
2.9%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) — 91.1; 96.1 percentage of participants
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) |
91.1; 96.1 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event |
1.0; 1.9 | — |
| SECONDARY Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4) |
93.1; 97.1 | — |
| SECONDARY Percentage of Participants Who Have HCV RNA < LLOQ at Week 2 |
51.0; 44.7 | — |
| SECONDARY Percentage of Participants Who Have HCV RNA < LLOQ at Week 4 |
85.0; 90.3 | — |
| SECONDARY Percentage of Participants Who Have HCV RNA < LLOQ at Week 8 |
99.0; 100.0 | — |
| SECONDARY Percentage of Participants Who Have HCV RNA < LLOQ at Week 12 |
99.0; 100.0 | — |
| SECONDARY HCV RNA at Week 2 |
1.52; 1.47 | — |
| SECONDARY HCV RNA at Week 4 |
1.22; 1.19 | — |
| SECONDARY HCV RNA at Week 8 |
1.15; 1.15 | — |
| SECONDARY HCV RNA at Week 12 |
1.15; 1.15 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 2 |
-4.67; -4.80 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 4 |
-4.96; -5.09 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-5.04; -5.13 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 12 |
-5.04; -5.13 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
5.9; 1.9 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
- Individuals with or without HIV-1 coinfection
Key Exclusion Criteria
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
- Co-infection with active hepatitis B virus
- Laboratory results outside the acceptable ranges at screening
- Pregnant or nursing female
- Chronic liver disease not caused by HCV
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02781558). 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.