妊娠替诺的安全及疗效-防止乙肝病毒的母婴传播

StephenW

Journal of Hepatology

Volume 61, Issue 3, September 2014, Pages 502–507
Cover image
Research Article
Efficacy and safety of tenofovir disoproxil fumarate in pregnancy to prevent perinatal transmission of hepatitis B virus

    Astrid-Jane Greenup1,
    Pok Kern Tan1,
    Vi Nguyen1,
    Anne Glass1,
    Scott Davison1,
    Ushmi Chatterjee2,
    Susan Holdaway3,
    Dev Samarasinghe3,
    Kathy Jackson4,
    Stephen A. Locarnini4,
    Miriam T. Levy1, 2, ,


        DOI: 10.1016/j.jhep.2014.04.038

Background & Aims

Perinatal transmission of hepatitis B virus still occurs despite immunoprophylaxis in approximately 9% of children from highly viraemic mothers. Antiviral therapy in this setting has been suggested, however with limited evidence to direct agent choice.
Methods

We conducted a multi-centre, prospective, opt-in observational study of antiviral safety and efficacy in pregnant women with high viral load (>7 log IU/ml); lamivudine was used from 2007 to 2010 and tenofovir disoproxil fumarate (TDF) from late 2010. Outcomes of treated and untreated cohorts were compared.
Results

120 women with 130 pregnancies used TDF (58), lamivudine (52 including four who switched due to TDF intolerance) and no therapy (20). 96% were HBeAg positive, with baseline viral load mean 7.8 log IU/ml (±0.72) and ALT median 25 U/L (18.75–33). Duration of antiviral theraphy before birth was mean 58 days (±19) TDF and 53 (±14) lamivudine. Viral load declined by 3.64 log IU/ml (±0.9) TDF and 2.81 log IU/ml (±1.33) lamivudine. Virologic failure (birth viral load >7 IU/ml) occurred in 3% and 18% respectively. Congenital abnormality rate and neonatal growth centiles were similar across cohorts. Perinatal transmission reduced significantly to 2% and 0% in TDF and lamivudine cohorts, compared with 20% in untreated.
Conclusions

TDF in this setting is safe, effective and more potent than lamivudine. Antiviral therapy did not adversely impact obstetric or infant parameters. More TDF intolerance occurred than expected. Perinatal transmission was significantly reduced in antiviral therapy cohorts.


    Corresponding author. Address: Department of Gastroenterology and Hepatology (Locked Mail Bag 7103), Liverpool Hospital, Elizabeth St, Liverpool, New South Wales 2170, Australia. Tel.: +61 287384085; fax: +61 287383094.

Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier Ireland Ltd. All rights reserved.

StephenW

中华肝脏病杂志

61卷，第3期，2014年9月，页502-507
封面图片
研究论文
疗效及妊娠富马酸替诺福韦酯的安全，防止乙肝病毒的母婴传播

    阿斯特丽德简Greenup1，
    学克恩TAN1，
    六Nguyen1，
    安妮Glass1，
    斯科特Davison1，
    Ushmi Chatterjee2，
    苏珊Holdaway3，
    开发Samarasinghe3，
    凯西Jackson4，
    斯蒂芬·Locarnini4，
    仪吨Levy1，2，，


        DOI：10.1016/ j.jhep.2014.04.038

背景与目的

乙肝病毒的母婴传播仍然出现，尽管从高病毒血症患儿的母亲约9％免疫预防。抗病毒治疗在此设置有建议，但有限的证据直接代理的选择。
方法

我们进行了一项多中心，前瞻性，选择在孕妇高病毒载量的抗病毒药安全性和疗效的观察性研究（>7登录国际单位/毫升）;拉米夫定用于2007年至2010年，并从处理和未处理的同伙2010年底成果富马酸替诺福韦酯（TDF）进行了比较。
结果

120妇女怀孕130使用TDF（58），拉米夫定（52，包括4谁交换由于TDF不耐受），不治疗（20）。 96％的HBeAg阳性，与基线病毒载量平均7.8登录国际单位/毫升（±0.72）和ALT值25 U / L（18.75-33）。出生前的抗病毒联合治疗的时间为平均58天数（±19）TDF和53（±14）拉米夫定。病毒载量由3.64下降登录国际单位/毫升（±0.9），TDF和2.81日志IU/毫升（±1.33），拉米夫定。病毒学失败（出生病毒载量>7 IU /毫升）分别发生在3％和18％。先天性畸形率和新生儿的生长百分位数分别为跨世代相似。母婴传播显著至2％，在TDF和拉米夫定队列0％减少，与在未经处理的20％进行比较。
结论

TDF在此设置是安全，有效，比拉米夫定更有效。抗病毒治疗没有产科或婴儿参数产生不利影响。发生多TDF不耐受超过预期。母婴传播是在抗病毒治疗的同伙显著减少。


    通讯作者。地址：胃肠病学和肝病学系（锁定邮袋7103），利物浦医院，伊丽莎白街，利物浦，新南威尔士州2170，澳大利亚。电话：+61287384085;传真：+61287383094。

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