[Study on the efficacy and safety profile of tenofovir alafenamide fumarate in the treatment of patients with decompensated hepatitis B cirrhosis].

Q3 Medicine
F Guo, X Wu, J Dou, Z H Ning, X B Wang, Q Xu, F P Ji, Y H Yue, Z G Wang, S S Dang, H F Wang, Q Fu, S T Zeng, W Z Zuo, X Z Wang
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Abstract

Objective: To explore the efficacy and safety profile of tenofovir alafenamide fumarate (TAF) in the treatment of patients with decompensated hepatitis B cirrhosis. Methods: A two-way cohort study method was used to enroll patients with decompensated hepatitis B cirrhosis who visited four medical centers, including Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, from April 2021 to April 2024 and were treated with TAF and followed up for 48 weeks. The primary efficacy indicator was hepatitis B virus (HBV) DNA seronegative conversion rate at 48-weeks, and the secondary efficacy indicator was alanine aminotransferase (ALT) return to normal rate at 48-weeks. Relevant safety indicators, adverse drug reactions (ADRs), and clinical adverse outcomes were collected. Results: A total of 74 cases were included. Of these, 52 were males with an average age of (53.14 ± 9.15) years. Twenty-five and thirty-three cases completed 24 and 48 weeks of follow-up, respectively. The HBV DNA negative conversion rate was 96.97% (32/33), which was higher than the baseline of 58.1% (43/74) following 48 weeks of TAF treatment. The ALT return to normal rate was 72.73% (24/33), which was higher than the baseline of 47.30% (35/74); however, the renal function and blood lipid levels did not change significantly compared with the baseline level after completing 48 weeks of treatment (P>0.05). During the follow-up period, one case developed hepatocellular carcinoma, and no other adverse clinical outcomes, such as liver transplantation or death, were reported. Conclusion: TAF has a good efficacy and safety profile in the treatment of patients with decompensated hepatitis B cirrhosis.

[富马酸替诺福韦阿拉那胺治疗失代偿期乙型肝炎肝硬化患者的疗效和安全性研究]。
目的:探讨富马酸替诺福韦(TAF)治疗失代偿期乙型肝炎肝硬化的疗效和安全性。方法:采用双向队列研究方法,纳入2021年4月至2024年4月在新疆维吾尔自治区中医医院等4个医疗中心就诊的失代偿期乙型肝炎肝硬化患者,给予TAF治疗,随访48周。主要疗效指标为48周时乙型肝炎病毒(HBV) DNA血清阴性转换率,次要疗效指标为48周时丙氨酸转氨酶(ALT)恢复正常率。收集相关安全指标、药物不良反应(adr)及临床不良结局。结果:共纳入74例。其中男性52例,平均年龄(53.14±9.15)岁。25例和33例分别完成了24周和48周的随访。TAF治疗48周后,HBV DNA阴性转阴率为96.97%(32/33),高于基线58.1%(43/74)。ALT恢复正常率为72.73%(24/33),高于基线的47.30% (35/74);治疗48周后,肾功能和血脂水平与基线水平比较无明显变化(P < 0.05)。随访期间,1例发生肝细胞癌,无其他不良临床结果,如肝移植或死亡报告。结论:TAF治疗失代偿期乙型肝炎肝硬化具有良好的疗效和安全性。
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来源期刊
中华肝脏病杂志
中华肝脏病杂志 Medicine-Medicine (all)
CiteScore
1.20
自引率
0.00%
发文量
7574
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