常规操作中从替诺福韦酯加富马酸替诺福韦酯替代芬太诺韦

StephenW

Treatment and renal outcomes up to 96 weeks after tenofovir alafenamide switch from tenofovir disoproxil fumarate in routine practice
Hidenori Toyoda  1 , Jennifer Leong  2 , Charles Landis  3 , Masanori Atsukawa  4 , Tsunamasa Watanabe  5 , Daniel Q Huang  6   7 , Joanne Liu  3   8 , Sabrina Xin Zi Quek  9 , Toru Ishikawa  10 , Taeang Arai  4 , Keisuke Yokohama  11 , Makoto Chuma  12 , Koichi Takaguchi  13 , Haruki Uojima  14 , Tomonori Senoo  13 , Hansen Dang  15 , Mayumi Maeda  15 , Joseph Hoang  15 , Richard H Le  15 , Satoshi Yasuda  1 , Khin N Thin  15 , Sally Tran  15 , Nicholas Chien  15 , Linda Henry  15 , Akira Asai  11 , Shinya Fukunishi  16 , Ramsey Cheung  15   17 , Seng Gee Lim  6   7 , Huy N Trinh  18 , Mindie H Nguyen  15
Affiliations
Affiliations

    1
    Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan.
    2
    Henry D. Janowitz Division of Gastroenterology, Mt. Sinai Health System, New York, NY, USA.
    3
    Division of Gastroenterology, University of Washington, Seattle, WA, USA.
    4
    Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.
    5
    Division of Gastroenterology and Hepatology, St. Marianna University School of Medicine, Kawasaki, Japan.
    6
    Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital, Singapore.
    7
    Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
    8
    University of Washington, Seattle, WA, USA.
    9
    Department of Medicine, National University Hospital, Singapore.
    10
    Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan.
    11
    2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
    12
    Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.
    13
    Department of Hepatology, Kagawa Prefectural Central Hospital, Kagawa, Japan.
    14
    Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
    15
    Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, CA, USA.
    16
    Premier Development Research of Medicine, Osaka Medical College, Osaka, Japan.
    17
    Division of Gastroenterology and Hepatology, The Palo Alto Veterans Affairs Health Care System, Palo Alto, CA, USA.
    18
    San Jose Gastroenterology, San Jose, CA, USA.

    PMID: 33706421 DOI: 10.1002/hep.31793

Abstract

Background: Real-world data for treatment effectiveness and renal outcomes in chronic hepatitis B (CHB) patients who were switched to the new and safer pro-drug, tenofovir alafenamide (TAF) from tenofovir disoproxil fumarate (TDF) are limited. Therefore, we aimed to evaluate treatment and renal outcomes of this population.

Approach & results: We analyzed 834 CHB patients previously treated with TDF for ≥12 months who were switched to TAF in routine practice at 13 U.S. and Asia centers for changes in viral (HBV DNA <20 IU/mL), biochemical (ALT <35/25 U/L for male/ female) and complete (viral+biochemical) response; as well as estimated glomerular filtration rate (eGFR, mL/min/1.73 m2 ) up to 96-weeks after switch. Viral suppression (P<0.001) and ALT normalization (P=0.003) rates increased significantly after switch, as well as trend for increasing complete response (Ptrend =0.004) while eGFR trend (Ptrend >0.44) or mean eGFR (P>0.83, adjusted for age, sex, baseline eGFR, and diabetes, hypertension or cirrhosis by generalized linear modeling) remained stable. However, among those with baseline eGFR <90 (CKD stage ≥2), mean eGFR decreased significantly while on TDF (P=0.029) but not after TAF switch (P=0.90). By week 96, 21% (55/267) of patients with CKD stage 2 at switch improved to stage 1, 35% (30/85) of CKD stage 3-5 patients improved to stage 2 and 1.2% (1/85) to stage 1.

Conclusion: Overall, we observed continued improvement in virologic response, ALT normalization, and no significant changes in eGFR following switch to TAF from TDF.

Keywords: ALT normalization; Effectiveness; chronic hepatitis B; chronic kidney disease; renal function.

This article is protected by copyright. All rights reserved.

StephenW

常规操作中从替诺福韦酯加富马酸替诺福韦酯替代芬太诺韦阿拉芬酰胺后长达96周的治疗和肾脏结局
丰田秀典1，梁静茹2，查理斯·兰迪斯3，安川正德4，渡边刚正5，丹尼尔·Q 6 7，刘安妮3 8，萨布丽娜·辛兹·奎克9，石川彻10，泰安新井4，横滨圭佑11，诚Chuma 12，Koichi Takaguchi 13，Haruki Uojima 14，Tomonori Senoo 13，Hansen Dang 15，Mayumi Maeda 15，Joseph Hoang 15，Richard H Le 15，Satoshi Yasuda 1，Khin N Thin 15，Sally Tran 15，Nicholas Chien 15，Linda亨利15，浅井晃11，新福喜16，拉姆齐张15 17，盛吉林6 7，惠南崔18，敏迪阮15
隶属关系
隶属关系

    1个
    日本大垣市大垣市立医院胃肠内科。
    2个
    亨利·D·詹诺维兹（Henry D.美国纽约州西奈卫生系统。
    3
    美国华盛顿大学华盛顿大学胃肠病学系。
    4
    日本东京日本医学院消化内科和肝病科。
    5
    日本川崎市圣玛丽安娜大学医学院胃肠病学和肝病学系。
    6
    新加坡国立大学医院医学部消化内科和肝病科。
    7
    新加坡国立大学Yong Loo Lin医学院医学系。
    8
    华盛顿大学，美国华盛顿州西雅图市。
    9
    新加坡国立大学医院医学系。
    10
    日本新泻市赛成会新泻医院消化内科。
    11
    日本大阪医学院第二内科。
    12
    日本横滨市立大学医学中心胃肠病学中心。
    13
    日本香川县中央医院肝病科。
    14
    日本相模原市北里大学医学院内科消化内科。
    15
    美国加利福尼亚州帕洛阿尔托，斯坦福大学医学中心消化内科和肝病科。
    16
    日本大阪医学院，医学高级发展研究。
    17
    美国加利福尼亚州帕洛阿尔托市帕洛阿尔托退伍军人事务卫生保健系统胃肠病学和肝病学部门。
    18岁
    美国加利福尼亚州圣何塞，圣何塞胃肠病学。

    PMID：33706421 DOI：10.1002 / hep.31793

抽象的

背景：从慢性乙型肝炎（CHB）患者改用新的和更安全的前药富马酸替诺福韦酯（TDF）替代替诺福韦阿拉芬酰胺（TAF）的实际数据有限。因此，我们旨在评估该人群的治疗和肾脏预后。

方法与结果：我们分析了834例先前接受TDF治疗≥12个月的CHB患者，这些患者在美国和亚洲13个中心的常规实践中转用TAF进行了病毒变化（HBV DNA <20 IU / mL），生化变化（ALT <35 / 25 U / L（男性/女性）和完整的（病毒+生化）响应；以及转换后长达96周的估计肾小球滤过率（eGFR，mL / min / 1.73 m2）。切换后病毒抑制（P <0.001）和ALT正常化（P = 0.003）率以及完全缓解趋势（Ptrend = 0.004）增加，而eGFR趋势（Ptrend> 0.44）或平均eGFR（P> 0.83，根据年龄，性别，基线eGFR以及糖尿病，高血压或肝硬化进行了调整（通过广义线性模型进行调整）保持稳定。但是，在基线eGFR <90（CKD≥2）的患者中，平均eGFR在TDF上显着下降（P = 0.029），而在TAF切换后却没有下降（P = 0.90）。到第96周，21％（55/267）的CKD 2期患者转为1期，35％（30/85）的CKD 3至5期患者改善为2期，1.2％（1/85）进入第一阶段

结论：总的来说，我们观察到病毒学应答，ALT正常化水平持续改善，并且从TDF转换为TAF后eGFR没有明显变化。

关键字：ALT正常化；效力;慢性乙型肝炎慢性肾病;肾功能。

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