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


METHODS
We 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 50 mg/GZR 100 mg, with or without ribavirin, for 8-18 weeks. Patients with CKD 3 (eGFR <60 to ≥30 mL/min/1.73 m2) at baseline plus ≥1 eGFR assessment postbaseline were included. In all studies, the primary endpoint was sustained virologic response 12 weeks after completion of therapy.


RESULTS
Thirty-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 56 mL/min/1.73 m2(range, 45-59) at baseline, 58 mL/min/1.73 m2(range, 41-78) at the end of treatment and 59 mL/min/1.73 m2(range, 38-78) 12 weeks after completing treatment.


CONCLUSIONS
Elbasvir/grazoprevir is a safe and effective treatment option for patients with compromised renal function, irrespective of baseline eGFR.
Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
K Rajender
KR
Reddy
Division of Nephrology and Hypertension, University of Miami Miller School of Medicine, Miami, Florida, USA.
David
D
Roth
Department of Renal Medicine, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
Annette
A
Bruchfeld
Merck & Co., Inc., Kenilworth, New Jersey, USA.
Peggy
P
Hwang
Merck & Co., Inc., Kenilworth, New Jersey, USA.
Barbara
B
Haber
Merck & Co., Inc., Kenilworth, New Jersey, USA.
Michael N
MN
Robertson
Merck & Co., Inc., Kenilworth, New Jersey, USA.
Eliav
E
Barr
Merck & Co., Inc., Kenilworth, New Jersey, USA.
Wayne
W
Greaves
chronic kidney disease; hepatitis C; retrospective; therapy