Entecavir treatment of hepatitis B virus‐infected patients with severe renal impairment and those on hemodialysis

Abstract

Aim Entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are first‐line nucleos(t)ide analogues for hepatitis B virus (HBV)‐infected patients. However, consecutive TDF treatment causes renal dysfunction, and the safety and efficacy of TAF have not been established in severe renal dysfunction patients, including hemodialysis patients. The efficacy and safety of ETV in these populations has not been clarified. The study aimed to clarify this. Methods In this retrospective multicenter study, between 2006 and 2018, a total of 567 HBV‐infected patients treated with ETV monotherapy were screened. Patients were included if >20 years old, treated with ETV monotherapy for >1 year, and had proper clinical information. The efficacy of ETV and changes in renal function were evaluated according to renal function. Results A total of 273 patients were included: 9.2% (25/273), 1.8% (5/273), and 3.7% (10/273) had chronic kidney disease (CKD) stage G3, CKD stage G4/5, and were on hemodialysis, respectively. Overall, 84.2%, 94.0%, and 96.2% of patients experienced serum HBV‐DNA disappearance at 1, 2, and 3 years, respectively, after treatment initiation. In patients with CKD stage G3–5, estimated glomerular filtration rate tended to restore with time, which was in contrast to patients without renal dysfunction. The rate of disappearance in serum HBV‐DNA, alanine transaminase normalization, and virological breakthrough was similar between patients with or without renal dysfunction. ETV showed high efficacy for all 10 hemodialysis patients without virological breakthrough. Conclusions Entecavir for HBV‐infected patients with severe renal dysfunction, including hemodialysis patients, is highly effective and does not affect renal function.

Early changes in tubular dysfunction markers and phosphorus metabolism regulators as a result of switching from entecavir to tenofovir alafenamide fumarate nucleoside analog therapy for chronic hepatitis B patients

“…that were recently published in Hepatology Research and Journal of Medical Virology . These authors concluded that entecavir (ETV) treatment and switching from ETV to tenofovir alafenamide (TAF) for hepatitis B virus‐infected patients do not affect renal function . This seems to contradict our study, which showed switching from ETV to TAF possibly brings about the early recovery of renal tubular damage.…”

Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus‐infected patients with renal impairment: results from a 7‐year, multicentre retrospective cohort study

“…Despite renal safety findings being similar for TDF and ETV in several retrospective studies, 29,30,32,33 ETV has been associated with a lower risk of proximal tubular toxicity than TDF, independent of pre‐existing renal impairment 34,35 . A retrospective study evaluated ETV in HBV‐infected patients, including 40 with renal dysfunction (estimated glomerular filtration rate ≤59 mL/min or receiving haemodialysis) 36 . While outcomes were similar between groups, estimated glomerular filtration rates declined over 5 years in patients without renal dysfunction at baseline (who had Grade 1‐2 chronic kidney disease), but this was not observed in those with baseline renal dysfunction 36 .…”

“…A retrospective study evaluated ETV in HBV‐infected patients, including 40 with renal dysfunction (estimated glomerular filtration rate ≤59 mL/min or receiving haemodialysis) 36 . While outcomes were similar between groups, estimated glomerular filtration rates declined over 5 years in patients without renal dysfunction at baseline (who had Grade 1‐2 chronic kidney disease), but this was not observed in those with baseline renal dysfunction 36 . Nonetheless, guidelines recommend renal monitoring for all patients at risk of renal disease, regardless of the nucleoside analogue received 10 …”

Hepatitis B surface antigen reduction as a result of switching from long‐term entecavir administration to tenofovir

“…Recently, nucleotide/nucleoside analog (NA) therapy has been widely used, which enables viral suppression and HCC suppression . However, considering the low rate of HBsAg elimination during NA therapy, administration must be continued for a long period of time . Therefore, new therapeutic strategies are required which target HBsAg clearance in patients undergoing long‐term NA administration.…”