EBR/GZR for HCV-1b Patients Receiving Hemodialysis
Status:
Completed
Trial end date:
2020-02-03
Target enrollment:
Participant gender:
Summary
Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of
antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin
(RBV), probably because the sustained virologic response (SVR) rates are low and the risk of
treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting
antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent
safety profiles to treat patients with severe renal impairment. With regard to
elbasvir/grazoprevir (EBR/GZR) treatment, a phase 3 study (C-SURFER) study has shown 99% of
SVR in HCV-1 patients with chronic kidney disease (CKD) stage 4 or 5. Furthermore, most
patients tolerated the treatment well. Although the data confirmed the excellent safety and
efficacy in HCV-1 patients with severe renal impairment, data regarding the safety and
efficacy for Asian HCV-1b patients receiving hemodialysis is lacking. Therefore, we aim to
evaluated the safety and efficacy of EBR/GZR for 12 weeks in treatment-naive and
treatment-experienced HCV-1b patients receiving hemodialysis.