Premium
Safety and efficacy of sofosbuvir‐containing regimens in hepatitis C‐infected patients with impaired renal function
Author(s) -
Saxena Varun,
Koraishy Farrukh M.,
Sise Meghan E.,
Lim Joseph K.,
Schmidt Monica,
Chung Raymond T.,
Liapakis Annmarie,
Nelson David R.,
Fried Michael W.,
Terrault Norah A.
Publication year - 2016
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.13102
Subject(s) - medicine , renal function , sofosbuvir , decompensation , gastroenterology , ribavirin , hepatitis c , dialysis , dosing , cohort , hepatitis c virus , immunology , virus
Background & Aims Renal clearance is the major elimination pathway for sofosbuvir ( SOF ). We assessed the safety and efficacy of SOF ‐containing regimens in patients with varying baseline estimated glomerular filtration rate ( eGFR ). Methods HCV ‐ TARGET database is a multicentre, longitudinal ‘real‐world’ treatment cohort. Results A total of 1789 patients [genotypes 1 (72%), 2 (17%) 3 (9%), 4–6 (2%)] had baseline eGFR determination: 73 with eGFR ≤45 (18 with eGFR ≤30, 5 on dialysis) were compared to 1716 with eGFR >45 ml/min/1.73 m 2 . Patients with baseline eGFR ≤45 vs. >45 differed in being female (55% vs. 36%), age ≥65 years (24% vs. 16%), Black race (22% vs. 12%), having cirrhosis with decompensation (73% vs. 24%) and being post‐transplant (49% vs. 10%), all P < 0.05. All patients with eGFR ≤45 were treated with SOF 400 mg/day (including those on haemodialysis) and had median starting ribavirin ( RBV ) dose of 800 mg ( IQR : 400–1200). Sustained virologic response ( SVR ) frequencies were similar across eGFR groups, ranging from 82–83%. Patients with eGFR ≤45 more frequently experienced anaemia, worsening renal function and serious AE s (all P < 0.05), and these associations persisted when limiting analysis to RBV ‐free regimens. Patients with baseline eGFR ≤30 and eGFR 31–45 had similar frequencies of efficacy and safety outcomes. Conclusions Sustained viral clearance was achieved in 83% of patients with renal impairment ( eGFR ≤45 ml/min/1.73 m 2 ) treated with SOF ‐containing regimens. However, these patients had higher rates of anaemia, worsening renal dysfunction and serious adverse events regardless of use of RBV . Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF ‐containing regimens.