替诺福韦酯富马酸酯或富马酸恩替卡韦治疗慢性乙型肝炎病

StephenW

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
Pietro Lampertico  1 , Thomas Berg  2 , Maria Buti  3 , Anita Pathil  4   5 , Joerg Petersen  6 , Stephen D Ryder  7 , Fabien Zoulim  8 , Irina Botros  9 , John F Flaherty  9 , Belinda Jump  9 , Marjoleine L Op den Brouw  9 , Anna van Troostenburg  9 , Heribert Ramroth  9 , ReCoRd (Retrospective, Cohort, Renal, Viread) Investigators' Group
Collaborators, Affiliations

    PMID: 32583915 DOI: 10.1111/apt.15901

Abstract

Background: Limited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus-infected (CHB) patients with renal impairment (RI).

Aims: To compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI.

Methods: Retrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation ('before' subgroup [baseline = treatment initiation]) or after TDF/ETV initiation ('after' subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting.

Results: 'Before' subgroup included 107 TDF- and 91 ETV-treated patients; 'after' subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV ('before': 18.7% vs 8.8%; 'after': 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% 'before'; 1.9% 'after') as well as renal adverse events leading to treatment discontinuation (8.4% 'before'; 7.1% 'after'). Effectiveness was similar between treatments.

Conclusions: Overall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

© 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

StephenW

替诺福韦酯富马酸酯或富马酸恩替卡韦治疗慢性乙型肝炎病毒感染的肾功能不全患者：一项为期7年的多中心回顾性队列研究的结果
Pietro Lampertico 1，Thomas Berg 2，Maria Buti 3，Anita Pathil 4 5，Joerg Petersen 6，Stephen D Ryder 7，Fabien Zoulim 8，Irina Botros 9，John F Flaherty 9，Belinda Jump 9，Marjoleine L Op den Brouw 9， Anna van Troostenburg 9，Heribert Ramroth 9，ReCoRd（回顾性，队列，肾脏，Viread）研究人员小组
合作者，隶属关系

    PMID：32583915 DOI：10.1111 / apt.15901

抽象

背景：关于替诺福韦富马酸替诺福韦（TDF）在慢性乙型肝炎病毒感染（CHB）肾功能不全（RI）患者中的安全性和有效性的数据有限。

目的：比较中度至重度RI的CHB患者的TDF与恩替卡韦（ETV）的肾脏安全性和有效性的真实数据。

方法：回顾性，非干预性队列研究，分析TDF / ETV治疗的CHB患者的病历（欧洲54个中心）。纳入的患者在TDF / ETV开始之前（“亚组[基线=治疗开始]之前）或TDF / ETV开始之后经历了中度至重度RI（肌酐清除率20-60 mL / min [Cockcroft-Gault]）。之后”子组[基线=第一个RI发生]。主要目标是TDF安全性，特别是与肾脏有关的特殊不良事件（AESI）。比较了TDF和ETV的安全性和有效性，并使用逆概率治疗权重进行了多元分析。

结果：“之前”亚组包括107名接受TDF治疗和91名接受ETV治疗的患者； “之后”亚组包括212名接受TDF治疗的患者和77名接受ETV治疗的患者。 TDF治疗组和ETV治疗组（两个亚组）的平均肌酐基线清除率均较高。中位随访时间为3。1年（两种治疗）。 TDF与ETV相比，AESI的发生频率更高（“之前”：18.7％对8.8％；“之后”：9.9％对3.9％）；但是，通过多变量分析，差异并不显着。只有经TDF治疗的患者经历了肾小管功能障碍（6.5％“之前”； 1.9％“之后”）以及导致治疗终止的肾脏不良事件（8.4％“之前”； 7.1％“之后”）。治疗之间的有效性相似。

结论：TDF与ETV（两个亚组）的总体安全性相似。考虑到TDF而非ETV发生了肾小管功能障碍，因此TDF对CHB RI患者的肾脏安全性担忧可能更大。

©2020作者。约翰·威利父子有限公司（John Wiley＆Sons Ltd.）出版的《消化药理学与治疗学》。

StephenW

https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/apt.15901