Telbivudine Prevents Vertical Transmission of Hepatitis B Virus From Women With High Viral Loads: A Prospective Long-Term Study
Telbivudine Prevents Vertical Transmission of Hepatitis B Virus From Women With High Viral Loads: A Prospective Long-Term Study
复制标题
替比夫定可预防高病毒载量女性乙型肝炎病毒的垂直传播：一项前瞻性长期研究
DOI：
10.1016/j.cgh.2014.08.043
复制
发表时间：
2015-06-01
影响因子：
12.6
通讯作者：
Wang, Yuming
中科院分区：
文献类型：
--
作者：
Wu, Quanxin;Huang, Hongfei;Wang, Yuming
背景与目的：B型肝炎病毒（HBV）感染是导致肝脏疾病的主要原因。我们在一项开放性研究中调查了替比夫定预防高病毒载量的B e抗原阳性孕妇将HBV传播给其婴儿的有效性和安全性。方法：我们对450例HBV DNA水平大于106 IU/mL的B e抗原阳性孕妇进行了前瞻性研究。279名妇女在妊娠第24 ~ 32周接受替比夫定（600 mg/d）治疗，171名不愿服用抗病毒药物的妇女作为对照。所有新生儿均按照标准免疫预防程序接种重组HBV疫苗和B型肝炎免疫球蛋白。通过检测出生后6个月婴儿的B型肝炎表面抗原和HBV DNA来确定HBV的母婴传播。结果：母亲给予替比夫定的婴儿在6个月时均未检测到B型肝炎表面抗原阳性，而对照组婴儿的阳性率为14.7%（P = 5.317 x 10（-8））。服用替比夫定的妇女HBV DNA水平也降低了; 172名服用替比夫定的妇女中有40名（23.2%）在分娩前HBV DNA水平检测不到，而对照组中没有一名妇女。替比夫定组脐带血中HBV DNA检测不到的比例（99.1%）显著高于对照组（61.5%; P = 1.195 x 10（-22））。没有严重的不良事件或并发症，观察妇女或婴儿。结论：替比夫定显着减少HBV从孕妇到婴儿的垂直传播，它是安全的，妇女和婴儿耐受良好。抗逆转录病毒药物妊娠登记系统卫生保健提供者编号：26592;政府编号：国家自然科学基金（NSFC）30830090，30972598;第三军医大学临床研究重点项目：2012 XLC 05）。
BACKGROUND & AIMS: Hepatitis B virus (HBV) infection is a leading cause of liver diseases. We investigated the efficacy and safety of telbivudine in preventing transmission of HBV from hepatitis B e antigenpositive pregnant women with high viral loads to their infants in an open-label study.METHODS: We performed a prospective study of 450 hepatitis B e antigen-positive pregnant women with HBV DNA levels greater than 106 IU/mL; 279 women received telbivudine (600 mg/d) during weeks 24 to 32 of gestation, and 171 women who were unwilling to take antiviral drugs participated as controls. All newborns were vaccinated with a recombinant HBV vaccine and hepatitis B immune globulin, according to a standard immunoprophylaxis procedure. Motherto-child transmission of HBV was determined by detection of hepatitis B surface antigen and HBV DNA in the infant 6 months after birth.RESULTS: None of the infants whose mothers were given telbivudine tested positive for of hepatitis B surface antigen at 6 months, compared with 14.7% of infants in the control group (P = 5.317 x 10(-8)). Levels of HBV DNA also decreased among women given telbivudine; 40 of 172 (23.2%) women given telbivudine had undetectable HBV DNA levels before delivery, compared with none of the controls. A significantly higher proportion of women given telbivudine had undetectable levels of HBV DNA in cord blood (99.1%) than controls (61.5%; P = 1.195 x 10(-22)). No severe adverse events or complications were observed in women or infants.CONCLUSIONS: Telbivudine significantly reduces vertical transmission of HBV from pregnant women to their infants; it is safe and well tolerated by women and infants. Antiretroviral Pregnancy Registry Health Care Providers ID: 26592; Government number: Natural Science Foundation of China (NSFC) 30830090, 30972598; and Third Military Medical University Key Project for Clinical Research: 2012XLC05).