Department of Obstetrics and Gynecology, Beijing Ditan Hospital affiliated to Capital Medical University, Beijing, China.
J Viral Hepat. 2013 Apr;20 Suppl 1:65-70. doi: 10.1111/jvh.12066.
Orally administered nucleus(t)ide analogues (NA) have brought about a simple, safe and effective therapeutic approach for chronic hepatitis B (CHB). However, treatment duration is long and some female patients become pregnant during treatment. In recent years, there have been gradually increasing reports on the safety of telbivudine (LdT) treatment for chronic hepatitis B virus (HBV) infection in the third trimester of pregnancy to block mother-to-infant transmission (MTIT) of HBV; however, the safety of LdT treatment for chronic HBV infection for the entire pregnancy has not been reported. The aim of the present study was to evaluate the safety of LdT treatment for chronic HBV infection for the entire pregnancy and provide a reference for HBV-infected fertile women on how to block MTIT of HBV. Eighty-six pregnant women who received LdT treatment either before or in early pregnancy were enrolled in the study. Adverse events were prospectively observed for the entire pregnancy and perinatal period, and short-term and long-term follow-up of infants was conducted, monitoring the abnormalities of infants and blocking rate of MTIT with LdT treatment. Eighty-six pregnant women treated with LdT had a total of 89 pregnancies: 6 (6.7%) had early embryonic death or spontaneous abortion, 1 (1.1%) had ectopic pregnancy and three had a second pregnancy after initial abortion. Fifty-one mothers completed pregnancy: one had induction of labour at 24 weeks of pregnancy for cleft lip and palate of the foetus and 50 delivered 52 full-term live infants. One infant had right ear accessories, and the total occurrence of congenital abnormality was 3.8%. Thirty-nine infants were followed up for more than 6 months and completed all examinations for MTIT. None of the infants were HBsAg positive, resulting in a 100% success rate of blocking MTIT. All mothers maintained good liver function during the third trimester of pregnancy; 86% maintained complete virological response (HBV DNA <500 copies/mL) prior to delivery, and none developed progression of liver disease. Factors leading to increased adverse effects and drug resistance were not found. LdT treatment is safe and effective in chronic HBV-infected pregnant mothers for the entire pregnancy.
口服核苷（酸）类似物（NA）为慢性乙型肝炎（CHB）带来了一种简单、安全、有效的治疗方法。然而，治疗时间长，一些女性患者在治疗期间怀孕。近年来，越来越多的报道称替比夫定（LdT）在妊娠晚期治疗慢性乙型肝炎病毒（HBV）感染以阻断母婴传播（MTIT）HBV 是安全的；然而，LdT 治疗慢性 HBV 感染整个妊娠的安全性尚未报道。本研究旨在评估 LdT 治疗慢性 HBV 感染整个妊娠的安全性，并为 HBV 感染的育龄妇女如何阻断 HBV 的 MTIT 提供参考。本研究共纳入 86 例在妊娠前或妊娠早期接受 LdT 治疗的孕妇。前瞻性观察整个妊娠和围产期的不良事件，并对婴儿进行短期和长期随访，监测婴儿的异常情况和 LdT 治疗阻断 MTIT 的情况。86 例接受 LdT 治疗的孕妇共有 89 例妊娠：6 例（6.7%）发生早期胚胎死亡或自然流产，1 例（1.1%）发生异位妊娠，3 例初次流产后再次妊娠。51 例母亲完成妊娠：1 例因胎儿唇腭裂在妊娠 24 周时引产，50 例分娩 52 例足月活产儿。1 例婴儿有右耳附件，先天性异常总发生率为 3.8%。39 例婴儿随访 6 个月以上，完成 MTIT 所有检查。无 1 例婴儿 HBsAg 阳性，阻断 MTIT 成功率为 100%。所有母亲在妊娠晚期肝功能良好；86%在分娩前保持完全病毒学应答（HBV DNA <500 拷贝/ml），无一例发生肝病进展。未发现导致不良反应和耐药性增加的因素。LdT 治疗慢性 HBV 感染的孕妇整个妊娠是安全有效的。
