Telbivudine for renal transplant recipients with chronic hepatitis B infection: a randomized controlled trial with early termination
Journal
Clinical and experimental nephrology
Journal Volume
24
Journal Issue
5
Pages
474
Date Issued
2020-05
Abstract
Background: The aim of this study was to analyze changes in renal function in HBsAg-positive renal transplant recipients receiving lamivudine who did or did not switch to telbivudine.
Methods: In this prospective randomized clinical trial (RCT), HBsAg-positive renal transplant recipients who had received lamivudine prophylaxis for at least 6 months were 1:2 randomized to receive either lamivudine or telbivudine for another 24 months. Renal function was evaluated by creatinine level and estimated glomerular filtration rate (eGFR) at the time of randomization (baseline), 6, 12, 18, and 24 months respectively.
Results: This RCT was prematurely terminated after recruiting only 17 patients due to a high incidence (61.5%; 8/13) of clinical myalgia in the telbivudine group. Cox's proportional hazards model revealed that there was no independent predictor of myalgia. Based on intention-to-treat and per protocol analyses using generalized estimating equations, the patients in the randomized telbivudine group had a significantly increased eGFR and the patients in the lamivudine group had a significantly decreased eGFR at the end of follow-up compared to the values at study enrollment. However, there was no significant difference between the lamivudine and telbivudine groups.
Conclusions: The renal protective effect of telbivudine for HBsAg positive renal transplant recipients was uncertain for high incidence of myalgia and only patients who were on telbivudine for 24 months had renal function maintenance.
Subjects
Hepatitis B virus (HBV)
Renal transplantation
Telbivudine
SDGs
Other Subjects
creatinine; hepatitis B surface antigen; lamivudine; telbivudine; antivirus agent; creatinine; hepatitis B surface antigen; lamivudine; telbivudine; adult; aged; antiviral therapy; Article; chronic hepatitis B; clinical article; controlled study; creatinine blood level; drug substitution; estimated glomerular filtration rate; female; graft recipient; human; intention to treat analysis; kidney function; kidney transplantation; male; myalgia; prospective study; randomized controlled trial; treatment duration; blood; chronic hepatitis B; chronic kidney failure; comparative study; complication; drug effect; early termination of clinical trial; glomerulus filtration rate; kidney; kidney transplantation; middle aged; myalgia; pathophysiology; time factor; Adult; Aged; Antiviral Agents; Creatinine; Early Termination of Clinical Trials; Female; Glomerular Filtration Rate; Hepatitis B Surface Antigens; Hepatitis B, Chronic; Humans; Kidney; Kidney Failure, Chronic; Kidney Transplantation; Lamivudine; Male; Middle Aged; Myalgia; Prospective Studies; Telbivudine; Time Factors
Publisher
SPRINGER
Type
journal article