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

• Status: Completed
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Ribavirin; Sofosbuvir; Velpatasvir

Criteria

Inclusion Criteria:

• Age > or = 20 years

• Chronic HCV infection, defined as detectable HCV antibody (anti-HCV; Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) and quantifiable serum HCV RNA (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, lower limit of quantification [LLOQ]: 25 IU/mL) for ≥ 6 months

Exclusion Criteria:

• Chronic kidney disease (CKD) stage ≥ 4,

• Organ transplantation

• Prior DAA exposure

• Refusal to provide written informed consent.