INTRODUCTION The course of maternal antiviral prophylaxis to prevent mother-to-child transmission of hepatitis B virus (HBV-MTCT) varies greatly, and it has not been demonstrated in a randomized controlled study. METHODS In this multicenter, open-label, randomized controlled trial, eligible pregnant women with HBV DNA of 5.3-9.0 log 10 IU/mL who received tenofovir alafenamide fumarate (TAF) from the first day of 33 gestational weeks to delivery (expected 8 week) or to 4 weeks postpartum (expected 12 week) were randomly enrolled at a 1:1 ratio and followed until 6 months postpartum. All infants received standard immunoprophylaxis (hepatitis B immunoglobulin and vaccine). The primary end point was the safety of mothers and infants. The secondary end point was the HBV-MTCT rate of infants at the age of 7 months. RESULTS Among 119 and 120 intention-to-treat pregnant women, 115 and 116 women were followed until delivery, and 110 and 112 per-protocol mother-infant dyads in 2 groups completed the study. Overall, TAF was well tolerated, no one discontinued the therapy due to adverse events (0/239, 0%, 95% confidence interval [CI] 0%-1.6%), and no infant had congenital defects or malformations at delivery (0/231, 0%, 95% CI 0%-1.6%). The infants' physical development at birth (n = 231) and at 7 months (n = 222) was normal. Furthermore, 97.0% (224/231, 95% CI 93.9%-98.5%) of women achieved HBV DNA <5.3 log 10 IU/mL at delivery. The intention-to-treat and per-protocol infants' HBV-MTCT rates were 7.1% (17/239, 95% CI 4.5%-11.1%) and 0% (0/222, 95% CI 0%-1.7%) at the age of 7 months. Comparatively, 15.1% (18/119, 95% CI 9.8%-22.7%) vs 18.3% (22/120, 95% CI 12.4%-26.2%) of women in the 2 groups had mildly elevated alanine aminotransferase levels at 3 months and 6 months postpartum, respectively ( P = 0.507); notably, no one experienced alanine aminotransferase flare (0% [0/119, 95% CI 0%-3.1%] vs 0% [0/120, 0%-3.1%]). DISCUSSION Maternal TAF prophylaxis to prevent HBV-MTCT is generally safe and effective, and expected 8-week prenatal duration is feasible. ClinicalTrials.gov , NCT04850950.

中文翻译：

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预期 8 周产前与 12 周围产期替诺福韦艾拉酚胺预防乙型肝炎病毒母婴传播：一项多中心、前瞻性、开放标签、随机对照试验。


引言 预防乙型肝炎病毒母婴传播 （HBV-MTCT） 的母体抗病毒预防病程差异很大，尚未在随机对照研究中得到证实。方法 在这项多中心、开放标签、随机对照试验中，HBV DNA 为 5.3-9.0 log 10 IU/mL 的合格孕妇，从孕 33 周的第一天到分娩（预计 8 周）或产后 4 周（预计 12 周）接受富马酸替诺福韦艾拉酚胺 （TAF） 的合格孕妇以 1：1 的比例随机入组，并随访至产后 6 个月。所有婴儿都接受了标准的免疫预防治疗（乙型肝炎免疫球蛋白和疫苗）。主要终点是母亲和婴儿的安全。次要终点是 7 个月大婴儿的 HBV-MTCT 率。结果 在 119 和 120 名意向治疗孕妇中，115 名和 116 名妇女被随访至分娩，2 组 110 名和 112 名符合方案的母婴二人组完成了研究。总体而言，TAF 耐受性良好，没有人因不良事件而停止治疗 （0/239， 0%，95% 置信区间 [CI] 0%-1.6%），分娩时没有婴儿出现先天性缺陷或畸形 （0/231， 0%，95% CI 0%-1.6%）。婴儿出生时 （n = 231） 和 7 个月时 （n = 222） 的身体发育正常。此外，97.0% （224/231,95% CI 93.9%-98.5%） 的妇女在分娩时达到 HBV DNA <5.3 log 10 IU/mL。7 月龄婴儿的意向治疗率和按方案婴儿的 HBV-MTCT 率分别为 7.1% （17/239， 95% CI 4.5%-11.1%） 和 0% （0/222， 95% CI 0%-1.7%）。相比之下，15.1% （18/119,95% CI 9.8%-22.7%） 对 18.3% （22/120,95% CI 12.4%-26.2 组妇女在产后 3 个月和 6 个月分别有 2% 的丙氨酸氨基转移酶水平轻度升高 （P = 0.507）;值得注意的是，没有人出现丙氨酸转氨酶发作 （0% [0/119， 95% CI 0%-3.1%] vs 0% [0/120， 0%-3.1%]）。讨论 预防 HBV-MTCT 的母体 TAF 预防通常是安全有效的，预计 8 周的产前持续时间是可行的。ClinicalTrials.gov ， NCT04850950.