drugset / Trial / NCT03118843
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NaSingle-groupOpen-labelTreatment
Summary
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
Timeline
- Start
- 2017-04-25
- Primary completion
- 2018-03-19
- Completion
- 2018-03-19
Publications
- Results Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |
| Subject | Voxilaprevir | Small molecule | 100 mg | Oral |
| Subject | velpatasvir | Other / unclassified | 100 mg | Oral |