替諾福韋酯富馬酸替諾福韋在減少中國慢性乙型肝炎的乙型

StephenW

Tenofovir Disoproxil Fumarate Is Superior to Entecavir in Reducing Hepatitis B Surface Antigen for Chronic Hepatitis B in China: 2-Year Comprehensive Comparative Result of a Matched Comparative Study
Sisi Yang  1 , Xueqing Ma  1 , Chengwei Cai  2 , Huanqiu Wang  1 , Fenqiang Xiao  3 , Chengbo Yu  1
Affiliations
Affiliations

    1
    State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
    2
    Department of Neurosurgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
    3
    Department of Emergency Surgery, Tongji Medical College, Union Hospital, Huazhong University of Science and Technology, Wuhan, China.

    PMID: 33791326 PMCID: PMC8005520 DOI: 10.3389/fmed.2021.637126

Abstract

Aim: Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are equally recommended as the first-line antiviral treatments for chronic hepatitis B (CHB) at present. We aimed to compare the long-term efficacy and safety between ETV and TDF therapy in CHB patients who had not received nucleoside analog treatment. Method: In this single-center retrospective study, 414 patients who received ETV (290 patients) or TDF (124 patients) therapy at our center from January 2017 to May 2019 were included. To reduce the imbalance of baseline variables, propensity score matching (PSM) was employed to yield 124 pairs of patients at a ratio of 1:1 based on the treatment regimen. Result: After PSM, the cumulative rate of patients who achieved complete virological response (CVR) was not different by drug therapy at each inspection time (1, 3, 6, 12, 18, and 24 months). Subgroup analysis on HBeAg status and level of HBV DNA demonstrated that evolution of proportion of achieving CVR was not significantly different between groups. Despite the insignificant incidence of HBsAg seroclearance in either group, patients in TDF group achieved higher on-treatment HBsAg decline at each inspection time (1, 3, 6, 9, 12, 18, and 24 months), 0.39, 0.51, 0.61, 0.64, 0.68, 0.76, and 0.91 log IU/mL, respectively; while the corresponding reduction were 0.27, 0.37, 0.40, 0.45, 0.48, 0.55, and 0.66 log IU/mL in ETV group (p < 0.05). In subgroup analysis, we found that the significant difference still existed in patients with high baseline HBsAg level (>3 log IU/mL). Additionally, the proportion of patients who achieved on-treatment HBsAg decline >1 log IU/mL in TDF and ETV group was 33.3 and 17.1% (p < 0.01) at the 12th month, 44.4 and 29.5% (p = 0.03) at the 24th month, respectively. Mean increase in serum creatinine from baseline was 0.10 and 0.08 mg/dL in TDF and ETV group (p = 0.11), with no patient experienced acute kidney injury. Conclusions: TDF has higher potency in reducing HBsAg than ETV in this study. Considering the effect still existed in patients with high HBsAg level (>3 log IU/mL), TDF might be a superior therapeutic regimen combining with its relatively safety.

Keywords: chronic hepatitis B; creatinine; entecavir; hepatitis B surface antigen; hepatocellular carcinoma; tenofovir disoproxil fumarate.

Copyright © 2021 Yang, Ma, Cai, Wang, Xiao and Yu.

StephenW

替诺福韦酯富马酸替诺福韦在减少中国慢性乙型肝炎的乙型肝炎表面抗原方面优于恩替卡韦：2年匹配比较研究的综合比较结果
杨思思1，马学清1，蔡成伟2，王焕秋1，肖奋强3，于成波1
隶属关系
隶属关系

    1个
    浙江大学医学院附属第一医院传染病诊治国家重点实验室，国家传染病临床研究中心，传染病诊治合作创新中心
    2个
    浙江大学医学院附属第二医院神经外科，杭州
    3
    华中科技大学联合医院同济医学院急诊外科，武汉

    PMID：33791326 PMCID：PMC8005520 DOI：10.3389 / fmed.2021.637126

抽象的

目的：目前均建议将替诺福韦富马酸替诺福韦（TDF）和恩替卡韦（ETV）作为慢性乙型肝炎（CHB）的一线抗病毒治疗药物。我们的目的是比较ETV和TDF治疗对未接受核苷类似物治疗的CHB患者的长期疗效和安全性。方法：这项单中心回顾性研究纳入了2017年1月至2019年5月在我们中心接受ETV（290例）或TDF（124例）治疗的414例患者。为了减少基线变量的不平衡，根据治疗方案，采用倾向得分匹配（PSM）以1：1的比例产生124对患者。结果：PSM后，在每个检查时间（1、3、6、12、18和24个月），通过药物治疗达到完全病毒学应答（CVR）的患者的累积率没有差异。对HBeAg状态和HBV DNA水平进行亚组分析表明，两组之间达到CVR的比例的演变没有显着差异。尽管两组中HBsAg血清清除率的发生率均无关紧要，但TDF组的患者在每个检查时间（1、3、6、9、12、18和24个月），0.39、0.51、0.61，分别为0.64、0.68、0.76和0.91 log IU / mL; ETV组相应的降低分别为0.27、0.37、0.40、0.45、0.48、0.55和0.66 log IU / mL（p <0.05）。在亚组分析中，我们发现基线HBsAg水平高（> 3 log IU / mL）的患者仍然存在显着差异。此外，在TDF和ETV组中，治疗中HBsAg下降> 1 log IU / mL的患者比例在第12个月分别为33.3和17.1％（p <0.01），在第12个月分别为44.4和29.5％（p = 0.03）。分别是24个月。在TDF和ETV组中，血清肌酐相对于基线的平均增加量分别为0.10和0.08 mg / dL（p = 0.11），没有患者遭受急性肾损伤。结论：在本研究中，TDF比ETV具有更高的降低HBsAg的能力。考虑到高HBsAg水平（> 3 log IU / mL）的患者仍然存在该效应，因此TDF结合其相对安全性可能是一种更好的治疗方案。

关键字：慢性乙型肝炎；肌酐恩替卡韦乙型肝炎表面抗原；肝细胞癌；替诺福韦酯富马酸酯。

版权所有©2021 Yang，Ma，Cai，Wang，Xiao and Yu。

StephenW

https://www.frontiersin.org/articles/10.3389/fmed.2021.637126/pdf

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TDF和ETV12个月降表面抗原1个log的比例为33.3和17.1%？