PrOD for Non-Cirrhotic Patients With HCV-1b Receiving Hemodialysis
Status:
Completed
Trial end date:
2018-12-25
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
ombitasvir/paritaprevir/ritonavir plus dasabuvir (PrOD) treatment, a phase 2 study (RUBY-1)
study has shown 90% of SVR in treatment-naive HCV-1 patients with chronic kidney disease
(CKD) stage 4 or 5. Among the HCV-1b patients, who received PrOD for 12 weeks, all 7 patients
achieved SVR. Although the data confirmed the excellent safety and efficacy in HCV-1b
patients with severe renal impairment, the patient number was small and the data with regard
to treatment-experienced patients was lacking. Therefore, we aimed to evaluated the safety
and efficacy of ProD for 12 weeks in treatment-naive and treatment-experienced HCV-1b
patients receiving hemodialysis.