Sandra Atlas Bass Center for Liver Diseases, Zucker School of Medicine at Hofstra/Northwell, 400 Community Drive, Manhasset, NY, 11030, USA.
San Jose Gastroenterology, 2331 Montpelier Dr., Suite B, San Jose, CA, 95116, USA.
Dig Dis Sci. 2022 Jun;67(6):2637-2645. doi: 10.1007/s10620-021-07033-y. Epub 2021 May 31.
Nucleos(t)ide analogues, with a proven record of safety and efficacy, have been the therapy of choice for over a decade for the treatment of chronic hepatitis B. The approval of tenofovir alafenamide (TAF) in 2016 provided an additional treatment option.
The aim of this study was to evaluate the characteristics and clinical outcomes of patients treated with TAF in usual clinical practice.
Retrospective data from electronic health records was obtained from those enrolled in TARGET-HBV, a longitudinal observational cohort study of patients with chronic hepatitis B managed according to local practice standards at community and academic medical centers throughout the U.S.
Of 500 patients enrolled, most were male (66%) and of Asian race (66%) with median age of 55 years. Cirrhosis was evident in 15%. Most patients (82%) had switched to TAF after treatment with other antivirals. The perceived safety profile of TAF was cited as the primary reason for changing therapy (32%). TAF was well tolerated and only 4 patients discontinued therapy due to adverse event during a median duration of TAF dosing of 74 weeks. Among those with paired laboratory data 12-18 months after switching to TAF, biochemical response and HBV DNA suppression was maintained. Most patients had normal renal function which was essentially unchanged throughout follow-up.
TAF is frequently utilized in routine clinical practice due to the perception of its improved safety profile. The current study supports the growing body of evidence regarding the safety and effectiveness of TAF. Trial Registration ClinicalTrials.gov identifier: NCT03692897, https://clinicaltrials.gov/ct2/show/NCT03692897 .
核苷（酸）类似物具有安全有效的良好记录，十多年来一直是治疗慢性乙型肝炎的首选治疗方法。2016 年替诺福韦艾拉酚胺（TAF）的批准提供了另一种治疗选择。
本研究旨在评估在常规临床实践中使用 TAF 治疗的患者的特征和临床结局。
从 TARGET-HBV 中获取电子健康记录的回顾性数据，这是一项在美国社区和学术医疗中心按照当地实践标准管理的慢性乙型肝炎患者的纵向观察队列研究。
在 500 名入组患者中，大多数为男性（66%）和亚洲裔（66%），中位年龄为 55 岁。15%的患者存在肝硬化。大多数患者（82%）在使用其他抗病毒药物治疗后改用 TAF。改用 TAF 的主要原因是认为 TAF 的安全性更好（32%）。TAF 耐受性良好，仅有 4 名患者因不良反应而在中位 TAF 治疗时间 74 周内停药。在改用 TAF 后 12-18 个月具有配对实验室数据的患者中，生化应答和 HBV DNA 抑制得以维持。大多数患者的肾功能正常，整个随访过程中基本没有变化。
由于认为 TAF 的安全性更好，TAF 在常规临床实践中经常被使用。目前的研究支持了越来越多关于 TAF 的安全性和有效性的证据。
ClinicalTrials.gov 标识符：NCT03692897，https://clinicaltrials.gov/ct2/show/NCT03692897。
