产妇富马酸替诺福韦酯打断母亲向婴儿传播乙肝病毒的疗效

StephenW

Viral Hepatitis
Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus

    Huey-Ling Chen1,2,3, Chien-Nan Lee4, Chin-Hao Chang5, Yen-Hsuan Ni1, Ming-Kwang Shyu3, Shih-Ming Chen7, Jen-Jan Hu8, Hans Hsienhong Lin9, Lu-Lu Zhao10, Shu-Chi Mu11, Ming-Wei Lai12, Chyi-Long Lee13, Hsien-Ming Lin14, Ming-Song Tsai15, Jenn-Jeih Hsu16, Ding-Shinn Chen3,6,17, K. Arnold Chan5, Mei-Hwei Chang1,3,* andthe Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study)

DOI: 10.1002/hep.27837

© 2015 by the American Association for the Study of Liver Diseases

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Hepatology

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    1    Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
    2    Primary Care Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
    3    Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
    4    Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
    5    Medical Research, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
    6    Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
    7    Department of Obstetrics and Gynecology, Taiwan Adventist Hospital, Taipei, Taiwan
    8    Department of Pediatrics, Taiwan Adventist Hospital, Taipei, Taiwan
    9    Departments of Internal Medicine, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan
    10    Department of Pediatrics, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan
    11    Department of Pediatrics, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
    12    Department of Pediatrics, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan
    13    Department of Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan
    14    Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, New Taipei City, Taiwan
    15    Department of Obstetrics and Gynecology, Cathay General Hospital, Taipei, Taiwan
    16    Department of Obstetrics and Gynecology, Taipei Chang Gung Memorial Hospital, Taipei, Taiwan
    17    Genomics Research Center, Academia Sinica, Nankang, Taiwan

*Correspondence author: Professor Mei-Hwei Chang, MD, Department of Pediatrics, National Taiwan University College of Medicine and Children's Hospital, Taipei 100, Taiwan, 17F, No. 8, Chung-Shan South Road, Tel: +886-2-2312-3456 ext. 71701, Fax: +886-2- 23114592, E-mail: [email protected]

Keywords:

    Maternal antiviral therapy;nucleotide analog;HBV immunization;children;pregnancy

Abstract

The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother-to-infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multi-center trial, enrolled 118 hepatitis B surface and e antigen (HBsAg, HBeAg)-positive pregnant women with HBV DNA ≥7.5 log10 IU/mL. The mothers received no medication (control group, N=56, HBV DNA 8.22±0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, N=62, HBV DNA 8.18±0.47 log10 IU/mL) from 30-32 weeks of gestation until one month postpartum. Primary outcome was infant HBsAg at 6-month-old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29±0.93 vs 8.10±0.56 log10 IU/mL, p<0.0001). Of the 121/123 newborns, TDF group had a lower rate of HBV DNA positivity at birth (6.15% vs 31.48%, P=0.0003), and HBsAg positivity at 6-month-old (1.54% vs 10.71%, P=0.0481). Multivariate analysis revealed TDF group with lower risk (odds ratio 0.10; P=0.0434), amniocentesis with higher risk (odds ratio 6.82; P=0.0220) of infant HBsAg positivity. TDF group had less incidence of maternal ALT levels above 2X upper limit of normal (ULN) for ≥ 3 months (3.23% vs 14.29%, P=0.0455); a less extent of postpartum elevations of ALT (P=0.007) and a lower rates of ALT > 5X ULN (1.64% vs 14.29%, P=0.0135) at 2 months postpartum. Maternal creatinine and creatinine kinase levels, rates of congenital anomaly, premature birth and growth parameters in infants were comparable in both groups. At 12 months, one TDF-group child newly developed HBsAg positivity, presumably due to postnatal infection and inefficient humoral responses to vaccines. Conclusions: TDF treatment for highly viremic mothers decreased infant HBV DNA at birth, infant HBsAg positivity at 6 months, and ameliorated maternal ALT elevations. This article is protected by copyright. All rights reserved.

StephenW

病毒性肝炎
产妇富马酸替诺福韦酯打断母亲向婴儿传播乙肝病毒的疗效

    休伊灵Chen1,2,3，建南Lee4，秦昊Chang5，颜轩NI1，铭卓宏Shyu3，施明Chen7，仁扬Hu8，汉斯Hsienhong Lin9，路路Zhao10，Shu-智Mu11，明伟Lai12，齐豫龙Lee13，献明Lin14，明宋Tsai15，爵Jeih Hsu16，鼎希恩Chen3,6,17，K.阿诺德Chan5，美Hwei Chang1,3，* andthe台湾研究组预防HBV的母亲向婴儿传播（PreMIT研究）

DOI：10.1002 / hep.27837

©2015年肝病研究的美国协会

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肝病

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作者信息

    儿科系1，医学和医院，台北，台湾台大医学院
    2初级保健医学，医学和医院的国立台湾大学，台北，台湾
    3肝炎研究中心，医学和医院的国立台湾大学，台北，台湾
    4妇产科，医学和医院，台北，台湾台大医学院
    5医学研究，医学和医院，台北，台湾台大医学院
    6内科，医学和医院，台北，台湾台大医学院
    妇产科，台安医院，台北，台湾的7系
    儿科，台安医院，台北，台湾的8处
    内科，佛教慈济综合医院，台北，台湾的9个部门
    儿科，佛教慈济综合医院，台北，台湾10处
    儿科，新光吴火狮纪念医院，台北，台湾11处
    儿科，林口长庚医院，林口，台湾12处
    妇产科，林口长庚医院，林口，台湾13处
    妇产科系14妇科，远东纪念医院，新北市，台湾
    妇产科，国泰医院，台北，台湾15处
    妇产科，台北长庚医院，台北，台湾16处
    17基因组学研究中心，中央研究院，南康，台湾

*通讯作者：教授美Hwei畅，医学博士，儿科系，医学院国立台湾大学和儿童医院，台北100，台湾，17F，8号，中山南路，电话：+ 886-2- 2312-3456分机。 71701，传真：+ 886-2- 23114592，电子邮箱：[email protected]

关键词：

    产妇抗病毒治疗;核苷酸类似物; HBV免疫，儿童，孕妇

抽象

疗效和产妇富马酸替诺福韦酯（TDF）在减少母亲对婴儿的乙肝病毒（HBV）的传输安全性尚不清楚。我们进行了一项前瞻性，多中心试验，入选118乙肝表面和E抗原（HBsAg，HBeAg的）阳性孕妇与HBV DNA≥7.5日志10 IU / mL的。母亲没有接受药物治疗（对照组，N = 56，HBV DNA 8.22±0.39日志10 IU / mL）或TDF 300毫克，每天（TDF组，N = 62，HBV DNA 8.18±0.47日志10 IU / mL）的从30-32孕周，直到产后一个月。主要成果是婴幼儿乙肝表面抗原为6个月大。在交付时，TDF组降低产妇HBV DNA水平（4.29±0.93 VS 8.10±0.56日志10 IU / mL时，P <0.0001）。在一百二十三分之一百二十一新生儿，TDF组HBV DNA阳性的出生率较低（6.15％和31.48％，P = 0.0003），与HBsAg阳性，在6个月大（1.54％和10.71％，P = 0.0481 ）。多变量分析显示TDF集团风险较低（比值比0.10; P = 0.0434）;婴儿的HBsAg阳性，羊膜穿刺术具有较高的风险（P = 0.0220比值比6.82）。 TDF组母体ALT水平高于正常上限（ULN）2X上限为≥3个月较少发生率（3.23％和14.29％，P = 0.0455）; ALT的升高产后（P = 0.007）和ALT的低利率的较低程度> 5倍ULN（1.64％和14.29％，P = 0.0135），在产后2个月。产妇肌酐和肌酐激酶水平，先天性异常，早产和婴儿的生长参数分别为可比在这两个群体。在12个月，1 TDF组子新开发的HBsAg阳性，大概是由于产后感染和低效体液应答的疫苗。结论：TDF治疗高病毒血症的母亲在出生时，婴儿的乙肝表面抗原阳性，6个月下降的婴儿HBV DNA和改善产妇ALT升高。这篇文章是受版权保护的。版权所有。

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结论:对高病毒定量的孕妇使用替诺治疗，降低了初生婴儿的DNA水平，婴儿6个月时表面抗原阳性发生率也低，还改善了产妇的转氨酶水平。