替诺福韦艾拉酚胺预防母婴HBV传播

StephenW

替诺福韦艾拉酚胺预防母婴HBV传播
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根据 The Liver Meeting Digital Experience 上发表的研究，替诺福韦艾拉酚胺疗法是安全的、耐受性良好的，并且可以防止乙型肝炎病毒从孕妇传染给婴儿。

目前，尽管在中国有妊娠期使用的指征，但关于富马酸替诺福韦二吡呋酯 (TDF) 或替诺福韦艾拉酚胺 (TAF) 给药的安全性和有效性的数据很少郑州大学第一附属医院在介绍中表示。在一项多中心研究中，研究人员旨在调查 TAF 治疗在预防母婴 HBV 传播方面的安全性和有效性。

登记的母亲根据患者的偏好接受 TAF（n = 103）或 TDF（n = 104），所有婴儿均接受免疫预防。对于母亲，Zeng 及其同事在分娩时、产后第 3 个月和产后第 6 个月评估了围产期不良事件、并发症、ALT 升高和肾功能变化。婴儿安全评估包括评估出生时的结构缺陷、Apgar 评分和从出生到出生的异常状况。 7个月。在治疗开始时，他们注意到平均胎龄为 1 周，丙氨酸转氨酶水平为 112.5 U/L，HBV DNA 水平为 4.6 log10 IU/mL。母亲和婴儿受到密切监测，直到产后至少 7 个月；最长的随访时间点是产后第 18 个月。

在服用 TAF 的母亲和服用 TDF 的母亲平均 96.1 周和 98.7 周的平均治疗持续时间中，研究人员观察到良好的耐受性。最常见的不良事件是恶心，发生在 29.1% 和 31.7% 的母亲身上，最常见的母亲并发症是胎膜早破（12.6% 和 13.5%）。在第 12 周开始 TAF 后，一名母亲因胎儿唇腭裂在妊娠第 23 周进行人工流产；研究人员注意到嘴唇和上颚在胚胎发生的 6 到 10 周内发育。他们通过随访进一步观察到婴儿没有先天性缺陷，身体和神经发育正常；母婴传播率降至0%。

“在大约 2 年的治疗期间，TAF 和 TDF 组对活跃的 HBV 母亲具有相当的安全性和有效性，”曾总结道。 “TAF 治疗可以作为患有活动性慢性 HBV 的母亲的替代选择。”

StephenW

Tenofovir alafenamide prevents mother-to-infant HBV transmission
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Tenofovir alafenamide therapy was safe, well-tolerated and prevented the transmission of hepatitis B virus from pregnant mothers to infants, according to research presented at The Liver Meeting Digital Experience.

Currently, few data exist investigating the safety and effectiveness of tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) administration among pregnant women with chronic HBV despite being indicated for use during pregnancy in China, Qing-Lei Zeng, MD, associate professor at The First Affiliated Hospital of Zhengzhou University, said during the presentation. In a multicenter study, researchers aimed to investigate the safety and effectiveness of TAF therapy in preventing mother-to-child HBV transmission.

Enrolled mothers received either TAF (n = 103) or TDF (n = 104) according to patient preference and all infants received immunoprophylaxis. For mothers, Zeng and colleagues evaluated perinatal adverse events, complications, ALT flare and changes in kidney function at delivery, postpartum month 3 and postpartum month 6. Infant safety assessments included evaluation of structural defects at birth, Apgar scores and abnormal conditions from birth to 7 months. At therapy initiation, they noted a mean gestational age of 1 week, an alanine aminotransferase level of 112.5 U/L and an HBV DNA level of 4.6 log10 IU/mL. Mothers and infants were closely monitored until at least 7 months postpartum; the longest follow-up timepoint was postpartum month 18.

During a mean treatment duration of 96.1 weeks among mothers dosed with TAF and 98.7 weeks among mothers dosed with TDF, researchers observed good tolerability. The most common adverse event was nausea which occurred in 29.1% and 31.7% of mothers and the most common maternal complication was premature rupture of membranes (12.6% and 13.5%). After initiating TAF at week 12, one mother underwent induced abortion at gestational week 23 due to fetal cleft lip and palate; the researchers noted the lip and palate develop by 6 to 10 weeks of embryogenesis. They further observed no congenital defects among infants as well as normal physical and neurological development through follow-up; the mother-to-child transmission rate reduced to 0%.

“The TAF and TDF groups had comparable safety and effectiveness for active HBV mothers during about 2 years of treatment,” Zeng concluded. “Treatment with TAF can serve as an alternative option for mothers with active chronic HBV.”