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Clinical and Experimental Nephrology
Erschienen in:

26.03.2020 | Original article

Telbivudine for renal transplant recipients with chronic hepatitis B infection: a randomized controlled trial with early termination

verfasst von: Ya-Wen Yang, Meng-Kun Tsai, Ching-Yao Yang, Chih-Yuan Lee, Bor-Luen Chiang, Hong-Shiee Lai

Erschienen in: Clinical and Experimental Nephrology | Ausgabe 5/2020

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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.
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Metadaten
Titel
Telbivudine for renal transplant recipients with chronic hepatitis B infection: a randomized controlled trial with early termination
verfasst von
Ya-Wen Yang
Meng-Kun Tsai
Ching-Yao Yang
Chih-Yuan Lee
Bor-Luen Chiang
Hong-Shiee Lai
Publikationsdatum
26.03.2020
Verlag
Springer Singapore
Erschienen in
Clinical and Experimental Nephrology / Ausgabe 5/2020
Print ISSN: 1342-1751
Elektronische ISSN: 1437-7799
DOI
https://doi.org/10.1007/s10157-020-01850-7

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