Phase 2
Completed N=323
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
Source: ClinicalTrials.gov NCT01909804 ↗Enrolled (actual)
323
Serious AEs
2.5%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 84.6; 96.4; 100.0; 100.0 percentage of participants
Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
84.6; 96.4; 100.0; 100.0; 57.7; 84.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 1.2; 0; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
88.5; 96.4; 100.0; 100.0; 61.5; 84.0 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
15.4; 3.6; 0; 0; 42.3; 12.0 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) ≥ 18 kg/m^2
- HCV RNA ≥ 10000 IU/mL at screening
- Prior treatment failure to a regimen including interferon with or without RBV
- HCV genotype 1 or 3
- Chronic HCV infection
- Cirrhosis determination
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
- Current or prior history of clinically significant illness other than HCV
- Screening ECG with clinically significant abnormalities
- Prior exposure to HCV specific direct acting antiviral agent
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of non-HCV etiology
- Hepatitis B
- Active drug abuse
- Use of any prohibited concomitant medications
Data sourced from ClinicalTrials.gov (NCT01909804). 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.