Ya-Wen Yang1,2, Meng-Kun Tsai2, Ching-Yao Yang2, Chih-Yuan Lee2, Bor-Luen Chiang1, Hong-Shiee Lai3,4. 1. Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. 2. Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan. 3. Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan. hslai@ntu.edu.tw. 4. Center for Surgical Development, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. hslai@ntu.edu.tw.
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.
RCT Entities:
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.
Entities:
Keywords:
Hepatitis B virus (HBV); Renal transplantation; Telbivudine
Authors: Ching-Lung Lai; Edward Gane; Yun-Fan Liaw; Chao-Wei Hsu; Satawat Thongsawat; Yuming Wang; Yagang Chen; E Jenny Heathcote; Jens Rasenack; Natalie Bzowej; Nikolai V Naoumov; Adrian M Di Bisceglie; Stefan Zeuzem; Young Myoung Moon; Zachary Goodman; George Chao; Barbara Fielman Constance; Nathaniel A Brown Journal: N Engl J Med Date: 2007-12-20 Impact factor: 91.245