尽管对约9％的高病毒载量母亲所生儿童进行了免疫预防，但乙肝病毒围产期传播仍有发生。现已建议使用抗病毒治疗，但直接选择药物治疗的证据有限。第64届美国肝病研究学会（AASLD）年会公布了一项研究，旨在评估抗病毒治疗预防围产期传播的有效性和安全性。
研究设计
研究者进行了一项多中心，前瞻性现实生活观察性研究，研究对象是高病毒载量（ > 7 log IU/ml）孕妇。研究者比较了TDF组、
研究结果
130名女性参与研究，其中58人采用TDF治疗，52人采用拉米夫定治疗（包括4名因TDF不耐受而转为拉米夫定治疗的患者），20人没有选择任何抗病毒治疗。平均基线病毒载量是7.8 log IU/mL（ + / - 0.72 ） ，平均基线ALT 是25 U/L（18.75-33）。96%的患者HBeAg阳性。TDF组抗病毒治疗时间为58天（ + / - 19），拉米夫定组为53天（ + / - 14）。TDF组孕产妇病毒载量平均下降3.55 log IU/mL（ + / - 0.87 ）（比先前报道的拉米夫定组（ 2.79 log IU/mL（ + / - 1.37） ）下降值高近1 log IU/mL）。TDF组孕产妇有3%发生病毒学失败。全部131婴儿存活。各队列婴儿先天性畸形率和体重，身长，头围中位数类似。TDF或拉米夫定队列未见围产期传播，但未治疗组有2例围产期传播。
结论
TDF和拉米夫定在此研究中有效和安全。TDF的胃肠道不耐受比预期更常见。与未治疗组相比，治疗组未见对孕产妇或婴儿参数的不利影响。抗病毒药物治疗可预防围产期传播。
原文摘要
Background and Aims:
Perinatal transmission of Hepatitis B Virus still occurs despite immune prophylaxis in approximately 9% of children from mothers with high viral load. Antiviral therapy use in this setting has been suggested but there is limited evidence to direct choice of agent.
Methods:
We conducted a multi-centre, prospective real life observational study of pregnant women with high viral load (>7 log IU/ml). We used antepartum lamivudine (2008 to 2010) and subsequently tenofovir disproxil fumarate (TDF) (from late 2010). The maternal and fetal efficacy and safety outcomes of the TDF cohort were compared to the lamivudine treated and untreated cohorts.
Results:
One hundred and thirty women participated, of whom 58 were treated with TDF, 52 lamivudine (including four who switched due to TDF intolerance) and 20 chose not to have any antiviral therapy. Mean baseline viral load was 7.8 log IU/mL (+/- 0.72); median baseline ALT was 25 U/L (18.75-33). Ninety six percent were HBeAg positive. Mean duration of antiviral therapy prior to birth viral load was 58 days (+/- 19) for TDF and 53 (+/- 14) for lamivudine. Viral load declined by mean 3.55 log IU/mL (+/- 0.87) in the TDF treated women. ( ~ 1 log greater decline than previously reported with lamivudine (2.79 log IU/mL (+/- 1.37)). Virological failure occurred in 3% of TDF pregnancies. All 131 babies born alive. Congenital abnormality rate and median weight, length and head circumference centiles at birth were similar in all cohorts. Perinatal transmission was not seen in either TDF or lamivudine treated cohorts compared with 2/10 transmission in untreated group.
Conclusions:
TDF and lamivudine were effective and safe in this setting. Gastrointestinal intolerance to TDF occurred more often than expected. No adverse impact on pregnancy or infant parameters was observed in treated compared to untreated cohorts. Perinatal transmission was prevented by either antiviral therapy.
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