Gastroenterology, Liverpool Hospital, Sydney, Australia.
University of New South Wales, Sydney, Australia.
J Hepatol. 2014 Sep;61(3):502-7. doi: 10.1016/j.jhep.2014.04.038. Epub 2014 May 5.
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.
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.
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.
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.
尽管乙型肝炎病毒（HBV）免疫预防在高病毒载量（>7 log IU/ml）的母亲所生儿童中约有 9%仍会发生围生期传播，但在这种情况下，已经有研究提出了抗病毒治疗，但指导药物选择的证据有限。
我们开展了一项多中心、前瞻性、自愿参与的观察性研究，纳入了高病毒载量（>7 log IU/ml）孕妇的抗病毒安全性和疗效；2007 年至 2010 年使用拉米夫定，2010 年末开始使用替诺福韦酯（TDF）。比较了治疗组和未治疗组的结局。
130 例妊娠中有 120 例（58 例）使用了 TDF，52 例（包括 4 例因 TDF 不耐受而改用 TDF 的患者）使用了拉米夫定，20 例未治疗。96%为 HBeAg 阳性，基线病毒载量平均值为 7.8 log IU/ml（±0.72），丙氨酸氨基转移酶（ALT）中位数为 25 U/L（18.75-33）。TDF 组和拉米夫定组在分娩前抗病毒治疗的平均时间分别为 58 天（±19）和 53 天（±14）。TDF 组病毒载量下降了 3.64 log IU/ml（±0.9），拉米夫定组下降了 2.81 log IU/ml（±1.33）。病毒学失败（出生时病毒载量>7 IU/ml）发生率分别为 3%和 18%。各组的先天畸形率和新生儿生长百分位数相似。与未治疗组的 20%相比，TDF 组和拉米夫定组的围生期传播率分别显著降低至 2%和 0%。
TDF 在这种情况下是安全、有效且比拉米夫定更有效。抗病毒治疗并未对产科或婴儿参数产生不利影响。TDF 不耐受的发生率高于预期。抗病毒治疗组的围生期传播明显减少。
