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替诺福韦阿米布芬酰胺和替诺福韦艾拉酚胺用于初治乙型肝炎相关失代偿期肝硬化的疗效与安全性

Efficacy and Safety of Tenofovir Amibufenamide and Tenofovir Alafenamide for First-Time HBV-Related Decompensated Cirrhosis.

作者信息

Rong Xinxin, Yang Guangde, Xu Yuanyuan, Chen He, Wang Xia, Fu Juanjuan, Li Li, Pan Xiucheng

机构信息

Department of Infectious Diseases, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.

出版信息

J Viral Hepat. 2025 Apr;32(4):e14029. doi: 10.1111/jvh.14029. Epub 2024 Oct 29.

Abstract

Clinical studies of tenofovir amibufenamide (TMF) and tenofovir alafenamide (TAF) treatment in patients with HBV-related decompensated cirrhosis (HBV-DC) are limited. This study evaluated the efficacy and safety of TMF versus TAF in naive-treated patients with first-time HBV-DC. Based on the antiviral drug used, patients were categorised into the TMF group and the TAF group. Virological and serological responses, hepatic and renal functions and blood lipid changes in both groups were evaluated during 48 weeks of treatment. A total of 98 patients were enrolled, 45 in the TMF group and 53 in the TAF group. At 48 weeks of treatment, the proportions of patients who achieved complete virological response (CVR) were 85.7% and 90.7%, respectively (p = 0.791). Improvement of at least 2 points in Child-Turcotte-Pugh scores was observed in 64.3% versus 79.1% (p = 0.169) of the patients. There were no significant changes in serum creatinine, estimated glomerular filtration rate or total cholesterol from baseline to week 48 between the two groups. Cystatin C remained stable in the TMF group but increased over time in the TAF group (p < 0.001). Low-density lipoprotein cholesterol remained stable in the TMF group but increased significantly in the TAF group at week 48 (p = 0.015). These results suggest that both TMF and TAF can rapidly suppress HBV replication, improve hepatic function and have no negative effects on renal function among patients with HBV-DC. Regarding lipid metabolism, both showed a better safety, while regular monitoring of blood lipid levels is recommended.

摘要

替诺福韦阿米布芬酰胺(TMF)和替诺福韦艾拉酚胺(TAF)治疗乙型肝炎病毒相关失代偿性肝硬化(HBV-DC)患者的临床研究有限。本研究评估了TMF与TAF在初治的首次发生HBV-DC患者中的疗效和安全性。根据使用的抗病毒药物,将患者分为TMF组和TAF组。在治疗的48周内评估两组的病毒学和血清学反应、肝肾功能及血脂变化。共纳入98例患者,TMF组45例,TAF组53例。治疗48周时,实现完全病毒学应答(CVR)的患者比例分别为85.7%和90.7%(p = 0.791)。Child-Turcotte-Pugh评分至少提高2分的患者比例分别为64.3%和79.1%(p = 0.169)。两组从基线到第48周血清肌酐、估计肾小球滤过率或总胆固醇均无显著变化。TMF组胱抑素C保持稳定,而TAF组随时间增加(p < 0.001)。TMF组低密度脂蛋白胆固醇保持稳定,而TAF组在第48周时显著升高(p = 0.015)。这些结果表明,TMF和TAF均可迅速抑制HBV-DC患者的HBV复制、改善肝功能且对肾功能无负面影响。关于脂质代谢,两者均显示出较好的安全性,同时建议定期监测血脂水平。

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