Background Hepatitis B virus (HBV) infection is a worldwide public health burden, especially in Asia and Africa. Concerns were raised that foetal exposure to HBV and antiretroviral therapy (ART) might suppress the innate immune response and reduce the production of hepatitis B surface antibody (HBsAb) in foetuses and infants. We therefore conducted the current study to evaluate the impact of ART on the development of the immune response to HBV in foetuses and infants. Methods We selected lamivudine instead of telbivudine or tenofovir as the intervention measurement because it was the oldest and most widely used ART during pregnancy and its safety data have been sufficiently documented. A comprehensive search was conducted in eight electronic databases, including four Chinese and four English databases. Studies that met the following eligibility criteria were included: human randomized controlled trials (RCTs); participants in the treatment group were exclusively exposed to lamivudine; participants in the control group were exposed to placebo, no treatment or hepatitis B immunoglobulin; all participants were HBV-positive pregnant women with a high viral load and the main outcome of interest was neonatal HBsAb seropositivity. Data were tabulated and analysed using R software. Results Nine RCTs were included and analysed. Compared with controls, lamivudine significantly decreased HBsAb seronegativity in the newborn within 24 h after birth (indicating the foetal immune response to HBV). Similar results were noted in infants within 6–7 months after birth and infants within 12 months (indicating the neonatal immune response to HBV vaccine). Conclusions Lamivudine treatment in late pregnancy boosted the foetal immune response to HBV in utero and enhanced the neonatal immune response to hepatitis B vaccine after birth.

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妊娠晚期拉米夫定治疗对胎儿乙型肝炎病毒免疫反应发展的影响：使用 Metafor 软件包在 R 中进行的荟萃分析

背景乙型肝炎病毒（HBV）感染是全球公共卫生负担，特别是在亚洲和非洲。人们担心胎儿接触乙肝病毒和抗逆转录病毒治疗（ART）可能会抑制胎儿和婴儿的先天免疫反应并减少乙型肝炎表面抗体（HBsAb）的产生。因此，我们进行了当前的研究，以评估 ART 对胎儿和婴儿对 HBV 免疫反应发展的影响。方法 我们选择拉米夫定代替替比夫定或替诺福韦作为干预措施，因为它是妊娠期间最古老、使用最广泛的 ART，且其安全性数据已得到充分记录。对八个电子数据库进行了全面检索，其中包括四个中文数据库和四个英文数据库。符合以下资格标准的研究包括：人类随机对照试验（RCT）；治疗组的参与者仅接受拉米夫定；对照组的参与者接受安慰剂、不接受治疗或接受乙型肝炎免疫球蛋白；所有参与者均为病毒载量高的 HBV 阳性孕妇，主要关注结果是新生儿 HBsAb 血清阳性。使用 R 软件对数据进行制表和分析。结果 纳入并分析了九项随机对照试验。与对照组相比，拉米夫定显着降低出生后24小时内新生儿的HBsAb血清阴性（表明胎儿对HBV的免疫反应）。在出生后 6-7 个月内的婴儿和 12 个月内的婴儿中也发现了类似的结果（表明新生儿对 HBV 疫苗的免疫反应）。结论妊娠晚期拉米夫定治疗可增强胎儿宫内乙型肝炎免疫反应，并增强新生儿出生后对乙型肝炎疫苗的免疫反应。