drugset / Trial / NCT03250910
Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are compare between the two groups. The characteristics potentially related to sustained virologic response 12 weeks off therapy (SVR12) are analyzed.
Timeline
- Start
- 2016-08-01
- Primary completion
- 2017-07-15
- Completion
- 2017-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | 1000 mg | — |
| Subject | Ribavirin | Small molecule | 1200 mg | — |
| Subject | Sofosbuvir | Small molecule | 400 mg | — |
| Subject | velpatasvir | Other / unclassified | 100 mg | — |