Elbasvir/grazoprevir does not worsen renal function in patients with hepatitis C virus infection and pre-existing renal disease

AimTreatment options have been limited for patients with hepatitis C virus (HCV) infection and chronic kidney disease stage 4/5 (CKD 4/5). The aim of this analysis was to evaluate the impact of elbasvir/grazoprevir (EBR/GZR) on estimated glomerular filtration rate (eGFR) in patients with CKD stage 3 enrolled in phase II/III clinical trials. MethodsWe undertook a retrospective integrated analysis of patients with CKD 3 enrolled in the EBR/GZR phase II/III clinical trials. All patients were required to have chronic HCV infection and have received EBR 50mg/GZR 100mg, with or without ribavirin, for 8-18weeks. Patients with CKD 3 (eGFR <60 to 30mL/min/1.73m(2)) at baseline plus 1 eGFR assessment postbaseline were included. In all studies, the primary endpoint was sustained virologic response 12weeks after completion of therapy. ResultsThirty-two patients with CKD 3 were identified from a pooled dataset of 1689 patients enrolled in the EBR/GZR clinical trial program. Thirty-one (97%) patients achieved SVR12 and one patient relapsed. In these 32 patients, there was no decline in median eGFR at the end of treatment or at follow-up week 12 compared with baseline. Median eGFR values were 56mL/min/1.73m(2) (range, 45-59) at baseline, 58mL/min/1.73m(2) (range, 41-78) at the end of treatment and 59mL/min/1.73m(2) (range, 38-78) 12weeks after completing treatment. DiscussionElbasvir/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.