在接受恩替卡韦治疗的慢性乙型肝炎患者中改用艾拉酚胺替

StephenW

在接受恩替卡韦治疗的慢性乙型肝炎患者中改用艾拉酚胺替诺福韦与继续治疗：一项前瞻性、多中心、随机对照研究
佐藤康介 1 , 井上润 1 , 赤羽武博 2 , 小林智雄 3 , 佐藤修一 4 , 木更纪弘 5 , 二宫雅志 1 , 岩田智明 1 , 佐野明志 1 , 鹤冈澪 1 , 大贯正纯 1 , 政宗敦志 1
隶属关系
隶属关系

    1
    日本宫城县仙台市东北大学医学研究生院胃肠病学系。
    2
    日本宫城县石卷市日本红十字石卷医院消化内科。
    3
    日本宫城县仙台市东北罗西医院肝病科。
    4
    日本宫城县栗原市栗原中央医院内科。
    5
    日本社区卫生保健组织仙台南医院消化内科，日本宫城县仙台市。

    PMID：36181074 DOI：10.1097/MD.0000000000030630

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抽象的

背景：恩替卡韦 (ETV) 和富马酸替诺福韦艾拉酚胺 (TAF) 已广泛用于治疗慢性乙型肝炎病毒 (HBV) 感染患者，但如何最好地使用这些药物仍不清楚。尽管一些研究比较了从 ETV 转换为 TAF 的治疗效果，但还没有随机研究。

方法：我们进行了一项前瞻性多中心随机对照研究，受试者于 2018 年 4 月至 2019 年 6 月入组，观察 2 年至 2021 年 3 月，以阐明从 ETV 转换为 TAF 的有效性和安全性。

结果：共纳入33例患者，随机分为2组，共评估30例；一个 TAF 切换组 (n = 16) 和一个 ETV 持续组 (n = 14)。 30 名患者的平均年龄为 61 岁，其中 18 名患者（60%）为男性。所有患者的血清HBV DNA均低于检测限。 2 年后乙型肝炎表面抗原 (HBsAg) 水平的平均变化在 TAF 和 ETV 组之间没有显着差异（-0.08 vs -0.20 log IU/mL，P = .07）。在总体分析中比较 HBsAg 下降组（≤ -0.1 log IU/mL）和没有 HBsAg 下降的组，HBsAg 下降组的先前 ETV 持续时间显着缩短（49 个月 vs 92 个月，P = . 03)。尽管与 ETV 相比，TAF 组的 eGFR 水平趋于降低（-6.15 vs -2.26 mL/min/1.73 m2，P = .09），但在基线 eGFR < 60 的患者中未观察到显着差异（-2.49 vs 0.40毫升/分钟/1.73 平方米，P = .25）。

结论：TAF转换组和ETV继续组的疗效和安全性相当。由于本研究是在有限的患者中进行的，因此需要进行更大规模的研究。

版权所有 © 2022 作者。由 Wolters Kluwer Health, Inc. 出版
利益冲突声明

作者没有利益冲突要披露。

StephenW

Switching to tenofovir alafenamide versus continued therapy in chronic hepatitis B patients who were treated with entecavir: A prospective, multicenter, randomized controlled study
Kosuke Sato  1 , Jun Inoue  1 , Takehiro Akahane  2 , Tomoo Kobayashi  3 , Shuichi Sato  4 , Norihiro Kisara  5 , Masashi Ninomiya  1 , Tomoaki Iwata  1 , Akitoshi Sano  1 , Mio Tsuruoka  1 , Masazumi Onuki  1 , Atsushi Masamune  1
Affiliations
Affiliations

    1
    Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
    2
    Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Miyagi, Japan.
    3
    Department of Hepatology, Tohoku Rosai Hospital, Sendai, Miyagi, Japan.
    4
    Department of Internal medicine, Kurihara Central Hospital, Kurihara, Miyagai, Japan.
    5
    Department of Gastroenterology, Japan Community Health Care Organization Sendai Minami Hospital, Sendai, Miyagi, Japan.

    PMID: 36181074 DOI: 10.1097/MD.0000000000030630

Free article
Abstract

Backgrounds: Entecavir (ETV) and tenofovir alafenamide fumarate (TAF) have been used widely to treat patients with chronic hepatitis B virus (HBV) infection, but it is still unclear how best to use these drugs. Although some studies compared the efficacies of treatment switch from ETV to TAF, there has been no randomized study.

Methods: We performed a prospective multicenter randomized controlled study in which subjects were enrolled from April 2018 to June 2019 and observed for 2 years until March 2021 to clarify the efficacy and safety of switching from ETV to TAF.

Results: Thirty-three patients were enrolled and randomized into 2 groups, and a total of 30 patients were evaluated; a TAF-switching group (n = 16) and an ETV-continuing group (n = 14). The mean age of the 30 patients was 61 years old and 18 patients (60%) were male. The serum HBV DNA in all patients were below detection limit. The mean change in hepatitis B surface antigen (HBsAg) levels after 2 years was not significantly different between the TAF and ETV groups (-0.08 vs -0.20 log IU/mL, P = .07). Comparing the group with a HBsAg decline (≤ -0.1 log IU/mL) and a group without a HBsAg decline in an overall analysis, the prior ETV duration was significantly shorter in the HBsAg-declined group (49 vs 92 months, P = .03). Although the eGFR levels tended to decrease in the TAF group compared to ETV (-6.15 vs -2.26 mL/min/1.73 m2, P = .09), no significant differences were observed in patients with baseline eGFR < 60 (-2.49 vs 0.40 mL/min/1.73 m2, P = .25).

Conclusion: The efficacy and safety were comparable in the TAF-switching group and the ETV-continuing group. Because the present study was conducted in limited patients, a larger study will be required.

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.
Conflict of interest statement

The authors have no conflicts of interest to disclose.

StephenW

https://doi.org/10.1097/md.0000000000030630