慢性乙型肝炎患者的脊柱骨密度增加,转换为特诺福维尔阿拉芬胺:一项前性,跨国研究
Eiichi Ogawa1, Dae Won Jun2,3, Hidenori Toyoda4
1Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
Alimentary pharmacology & therapeutics
|October 26, 2023
概括
在慢性乙型肝炎患者中,切换为天诺福维尔阿拉芬胺 (TAF) 显著改善了病毒抑制和骨密度. 切换后,功能保持稳定,表明TAF.
科学领域:
- 肝病学和病毒学.
- 药理学和药物安全问题
背景情况:
- 有限的数据存在于切换到tenofovir alafenamide (TAF) 的患者从核胺类同类 (NUCs) 除了tenofovir disoproxil fumarate (TDF) 之外.
- 转换TAF后评估治疗和安全结果对于管理慢性乙型肝炎 (CHB) 至关重要.
研究的目的:
- 评估CHB患者从其他NUC切换到TAF的病毒抑制,生化反应和/骨安全性.
- 分析TAF转换后估计的膜过率 (eGFR) 和腰椎T分数的变化.
主要方法:
- 预计将在日本,韩国,台湾和美国的14个中心招收270名成年CHB患者.
- 患者从任何NUC转换为TAF,结果包括病毒抑制 (HBV DNA <20 IU/mL),生化反应,eGFR和L脊柱T分数在24个月后进行评估.
- 进行了多变量分析,以确定与骨密度和功能变化相关的因素.
主要成果:
- 转换后24个月,病毒抑制率从95.2%显著增加到98.8% (p=0.014).
- 平均腰椎T分数从-1.43显著改善到-1.17 (p<0.0001),而平均eGFR保持稳定 (p=0.13).
- 男性的性别与恶化脊柱T分数的风险较低有关,而年龄较大与恶化CKD阶段的风险更高相关.
结论:
- 在CHB患者中切换到TAF导致24个月后病毒抑制和骨矿物质密度的显著改善.
- 功能得到维持,这表明TAF是其他NUCs患者的安全替代品.
- 研究结果支持TAF作为一种有效的治疗选择,具有有利的骨和脏安全概况.
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