替诺福韦拉芬酰胺预防围产期乙型肝炎传播：多中心，前瞻

StephenW

Tenofovir Alafenamide to Prevent Perinatal Hepatitis B Transmission: A Multicenter, Prospective, Observational Study


          CID Jan 4 2021

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Summary: Rare clinical data are available regarding TAF treatment during pregnancy. This multicenter, prospective, TDF-controlled, observational study demonstrated that TAF was safe for highly viremic pregnant women and their infants and reduced the mother-to-child transmission rate of HBV to 0%.

This study was accepted as an Oral Presentation (publication number: 0160) by the 2020 AASLD Annual Meeting and has been selected for inclusion in the Best of The Liver Meeting summary slide deck in the Hepatitis B category and awarded the AASLD International Early Career Investigator Award (to Dr. Qing-Lei Zeng).
In China, TAF was licensed for the treatment of CHB in December 2018; the drug label indicates, "TAF can be used during pregnancy if necessary", but it discourages breastfeeding when taking TAF. In real-world clinical practice, an increasing number of highly viremic pregnant Chinese women take TAF as antiviral prophylaxis for the prevention of MTCT of HBV. In this report, we describe the safety and effectiveness of TAF to prevent MTCT of HBV in a real-world setting.

Abstract

Background

Few safety and effectiveness results have been published regarding the administration of tenofovir alafenamide fumarate (TAF) during pregnancy for the prevention of mother-to-child transmission (MTCT) of hepatitis B virus (HBV).

Methods

In this multicenter prospective observational study, pregnant women with HBV DNA levels higher than 200,000 IU/ml who received TAF or tenofovir disoproxil fumarate (TDF) from gestational weeks 24-35 to delivery were 1:1 enrolled and followed until postpartum month 6. Infants received immunoprophylaxis. The primary endpoint was the safety of mothers and infants. The secondary endpoint was the hepatitis B surface antigen (HBsAg)-positive rate at 7 months for infants.

Results

In total, 116 and 116 mothers were enrolled, and 117 and 116 infants were born, in the TAF and TDF groups, respectively. TAF was well tolerated during a mean treatment duration of 11.0 weeks. The most common maternal adverse event was nausea (19.0%). One (0.9%), 3 (2.6%), and 9 (7.8%) mothers had abnormal alanine aminotransferase levels at delivery and at postpartum months 3 and 6, respectively. The TDF group had safety profiles that were comparable to those of the TAF group. No infants had birth defects in either group. The infants' physical and neurological development at birth and at 7 months in the TAF group were comparable with those in the TDF group. The HBsAg positive rate was 0% at 7 months in all 233 infants.

Conclusion

Antiviral prophylaxis with TAF was determined to be generally safe for both mothers and infants and reduced the MTCT rate to 0%.

StephenW

替诺福韦拉芬酰胺预防围产期乙型肝炎传播：多中心，前瞻性，观察性研究


  CID 2021年1月4日

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摘要：有关妊娠期TAF治疗的罕见临床数据。这项多中心，前瞻性，由TDF控制的观察性研究表明，TAF对于高病毒血症孕妇及其婴儿是安全的，并将母婴的HBV传播率降低至0％。

这项研究被2020年AASLD年会接受为一次口头报告（出版物号：0160），并被选入B型肝炎类别的“最佳肝病会议”摘要幻灯片组，并获得了AASLD国际早期职业研究者奖（曾庆雷博士）。
在中国，TAF于2018年12月获得了治疗CHB的许可;药物标签上注明“如果需要，可以在怀孕期间使用TAF”，但是在服用TAF时不鼓励母乳喂养。在现实世界的临床实践中，越来越多的高病毒血症孕妇将TAF用作抗病毒药物，以预防HBV的MTCT。在本报告中，我们描述了在现实环境中TAF预防HBV MTCT的安全性和有效性。

抽象的

背景

关于预防妊娠期乙型肝炎病毒（MTV）母婴传播的替诺福韦阿拉法酰胺富马酸酯（TAF）的使用，很少有安全性和有效性的结果发表。

方法

在这项多中心前瞻性观察性研究中，从妊娠第24至35周至分娩接受TAF或替诺福韦富马酸替诺福韦酯（TDF）的HBV DNA水平高于200,000 IU / ml的孕妇，以1：1的比例入组，并随访至产后第6个月。接受了免疫预防。主要终点是母亲和婴儿的安全。次要终点是婴儿在7个月时的乙型肝炎表面抗原（HBsAg）阳性率。

结果

在TAF和TDF组中，总共有116和116名母亲入组，分别有117和116名婴儿出生。在平均11.0周的治疗期间，TAF的耐受性良好。最常见的产妇不良事件是恶心（19.0％）。 1名（0.9％），3名（2.6％）和9名（7.8％）的母亲分别在分娩时和产后第3和6个月的谷丙转氨酶水平异常。 TDF组的安全性与TAF组相当。两组均无出生缺陷。 TAF组婴儿在出生时和7个月时的身体和神经发育与TDF组相当。所有233例婴儿的7个月内HBsAg阳性率为0％。

结论

已确定，使用TAF进行抗病毒预防对于母亲和婴儿都通常是安全的，并将MTCT率降低至0％。

StephenW

https://natap.org/2021/HBV/ciaa1939.pdf