替诺福韦、富马酸替诺福韦二氧吡酯和恩替卡韦治疗乙型肝炎病毒相关急性慢性肝衰竭的长期疗效和安全性:一项144周的数据分析

Q2 Medicine
Yeqiong Zhang , Wenxiong Xu , Zhexuan Deng , Lu Wang , Xingrong Zheng , Xiang Zhu , Xuejun Li , Jianguo Li , Xin Shu , Jing Lai , Liang Peng , Chan Xie
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引用次数: 0

摘要

背景和目的抗病毒治疗对乙型肝炎病毒相关的急性慢性肝衰竭(HBV-ACLF)至关重要。在全球范围内,没有关于替诺福韦(TAF)、富马酸替诺福韦(TDF)或恩替卡韦(ETV)治疗HBV-ACLF的长期预后或安全性的数据。本研究旨在探讨三种核苷类似物治疗HBV-ACLF的长期疗效和安全性。方法在这项前瞻性、现实世界队列研究中,HBV-ACLF患者被分配到TAF、TDF和ETV组。共有199名患者完成了144周的随访。倾向评分匹配(PSM)后,每组剩余44例患者进一步分析生存状况、肝细胞癌(HCC)发生率、病毒学反应和肝肾功能指标。结果在初始队列中,每组均有1例患者发生HCC。未观察到严重的药物相关不良事件。在PSM队列中,TAF、TDF和ETV组144周生存率分别为56.82%、75.00%和59.09% (P = 0.118)。基线分无肝硬化亚组和肝硬化亚组时,ETV组在无肝硬化患者中的生存率略低于TAF和TDF组(P = 0.338), TAF组在肝硬化患者中的生存率略低于TDF和ETV组(P = 0.052),但差异无统计学意义。TAF组、TDF组和ETV组的长期总生存率具有可比性。144周后,除了TDF组的天冬氨酸转氨酶水平显著高于ETV组(P = 0.001)外,三组间病毒学应答率及肝肾功能指标均无显著差异(P = 0.001)。结论使用这三种核苷类似物治疗HBV-ACLF在生存率、HCC发生率、疗效和安全性方面无显著差异。临床试验注册:clinicaltrials .gov NCT03920618。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Long-term efficacy and safety of tenofovir alafenamide, tenofovir disoproxil fumarate, and entecavir in treating hepatitis B virus-related acute-on-chronic liver failure: A 144-week data analysis

Long-term efficacy and safety of tenofovir alafenamide, tenofovir disoproxil fumarate, and entecavir in treating hepatitis B virus-related acute-on-chronic liver failure: A 144-week data analysis

Background and aims

Antiviral therapy is essential for hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF). No data are available on the long-term prognosis or safety of tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), or entecavir (ETV) in treating HBV-ACLF globally. This study was conducted to investigate the long-term efficacy and safety of the three nucleos(t)ide analogs in the treatment of HBV-ACLF.

Methods

In this prospective, real-world cohort study, patients with HBV-ACLF were assigned to the TAF, TDF, and ETV groups. A total of 199 patients completed the 144-week follow-up. After propensity score matching (PSM), 44 patients remained in each group for further analysis of survival status, incidence of hepatocellular carcinoma (HCC), virological response, and liver and renal function indicators.

Results

In the original cohort, HCC developed in one patient in each group. No serious drug-related adverse events were observed. In the PSM cohort, the 144-week survival rates were 56.82%, 75.00%, and 59.09% in the TAF, TDF, and ETV groups, respectively (P = 0.118). When stratified into noncirrhosis and cirrhosis subgroups at baseline, the survival rate of the ETV group was slightly lower than that of the TAF and TDF group in noncirrhosis patients (P = 0.338), and the survival rate of the TAF group was slightly lower than that of the TDF and ETV group in cirrhosis patients (P = 0.052), but the differences were not statistically significant. The long-term overall survival rates in the TAF, TDF, and ETV groups were comparable. After 144 weeks, no significant difference in the virological response rate or liver or renal function indicators was found among the three groups, except for the level of aspartate aminotransferase, which was significantly higher in the TDF group than in the ETV group at week 144 (P = 0.001).

Conclusions

There were no significant differences in the survival rate, incidence of HCC, efficacy or safety associated with the use of these three nucleos(t)ide analogs in treating HBV-ACLF.

Trial registration

ClinicalTrials.gov NCT03920618.
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来源期刊
Liver Research
Liver Research Medicine-Gastroenterology
CiteScore
5.90
自引率
0.00%
发文量
27
审稿时长
13 weeks
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