drugset / Trial / NCT03250910

Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients

NCT03250910

Phase 4 Completed 228 enrolled National Taiwan University Hospital
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

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 1000 mg
Subject Ribavirin Small molecule 1200 mg
Subject Sofosbuvir Small molecule 400 mg
Subject velpatasvir Other / unclassified 100 mg