Yang Young-Mo, Choi Eun Joo
Department of Pharmacy, College of Pharmacy, Chosun University, Gwangju, South Korea.
Ther Clin Risk Manag. 2017 Sep 26;13:1273-1285. doi: 10.2147/TCRM.S143286. eCollection 2017.
Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are recommended as the first-line therapy for chronic hepatitis B (CHB) due to their genetic barrier to resistance and effectiveness of virological suppression. TDF and ETV may cause renal toxicity through various mechanisms such as renal tubular injury, apoptosis, and mitochondrial toxicity. The aims of the current review were to assess the potential renal toxicity associated with the use of TDF and ETV in patients infected with chronic hepatitis B virus (HBV) and to provide clinical perspectives on these two agents in the treatment of CHB.
A literature search of clinical studies published in PubMed and posted on ClinicalTrials.gov website was implemented to find studies evaluating the potential renal toxicity of TDF and ETV.
Twenty-one studies were examined in this review. The TDF dose used in the studies was 245 or 300 mg/day and that of ETV was 0.5 or 1 mg/day. Based on the markers of renal function, patients treated with TDF were not more likely to show changes in renal function than those treated with ETV; however, the estimated glomerular filtration rates (eGFRs) of patients receiving TDF tended to be more clearly reduced than those of patients receiving ETV. The eGFRs of patients treated with TDF decreased in a time-dependent manner, whereas those of patients treated with ETV increased or decreased across various time points.
The data shown in this study suggest that use of TDF and ETV could be at least associated with reductions in renal function in patients with chronic HBV infection. However, various risk factors, such as pre-existing renal failure and comorbidities, are also associated with decreased renal function during the treatment of TDF and ETV. Thus, studies of management strategies for HBV-infected patients with these risk factors are necessary in the near future.
富马酸替诺福韦二吡呋酯（TDF）和恩替卡韦（ETV）因其对耐药的基因屏障以及病毒学抑制效果，被推荐作为慢性乙型肝炎（CHB）的一线治疗药物。TDF和ETV可通过多种机制导致肾毒性，如肾小管损伤、细胞凋亡和线粒体毒性。本综述的目的是评估慢性乙型肝炎病毒（HBV）感染患者使用TDF和ETV相关的潜在肾毒性，并提供这两种药物治疗CHB的临床观点。
在PubMed上发表的临床研究以及ClinicalTrials.gov网站上发布的研究进行文献检索，以寻找评估TDF和ETV潜在肾毒性的研究。
本综述共审查了21项研究。研究中使用的TDF剂量为245或300毫克/天，ETV剂量为0.5或1毫克/天。基于肾功能指标，接受TDF治疗的患者肾功能变化的可能性并不高于接受ETV治疗的患者；然而，接受TDF治疗的患者的估计肾小球滤过率（eGFR）往往比接受ETV治疗的患者更明显地降低。接受TDF治疗的患者的eGFR呈时间依赖性下降，而接受ETV治疗的患者的eGFR在不同时间点有所增加或下降。
本研究显示的数据表明，使用TDF和ETV至少可能与慢性HBV感染患者的肾功能下降有关。然而，各种风险因素，如既往存在的肾衰竭和合并症，也与TDF和ETV治疗期间的肾功能下降有关。因此，近期有必要对有这些风险因素的HBV感染患者的管理策略进行研究。
