现实世界研究替诺福韦地索普西富马酸盐预防高病毒载量母

StephenW

Aliment Pharmacol Ther. 2018 Dec 2. doi: 10.1111/apt.15064. [Epub ahead of print]
Real-world study of tenofovir disoproxil fumarate to prevent hepatitis B transmission in mothers with high viral load.
Wang M1, Bian Q1, Zhu Y1, Pang Q1, Chang L1, Li R1, Tiongson BC2, Zhang H1, Pan CQ3.
Author information

1
    Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China.
2
    Interfaith Medical Center, Brooklyn, , New York.
3
    Division of Gastroenterology, Department of Medicine, NYU Langone Health, NYU School of Medicine, New York City, NY.

Abstract
BACKGROUND:

Data on tenofovir disoproxil fumarate (TDF) therapy for preventing vertical transmission of hepatitis B virus (HBV) in the real-world setting are limited.
AIMS:

To investigate TDF for preventing vertical transmission of HBV in real-world practice.
METHODS:

Hepatitis B e-antigen (HBeAg)-positive mothers with HBV-DNA >6 log10 IU/mL to receive TDF between gestational weeks 24-33 and delivery were prospectively enrolled and followed until post-partum week 28. All infants received immunoprophylaxis. Primary endpoints were safety of TDF use and mother-to-child transmission rates. Secondary outcomes were maternal HBV-DNA level suppression (<200 000 IU/mL) at delivery and HBeAg and hepatitis B surface antigen (HBsAg) serologic changes during the study.
RESULTS:

Among 147 mothers enrolled, 143 started TDF and 143/144 infants completed the study. At delivery, 93.7% (134/143) of the mothers achieved HBV-DNA<200 000 IU/L. On-treatment, alanine aminotransferase (ALT) flares were observed in 8.4% (12/143) of mothers. After TDF cessation, ALT increased in 7.7% (11/143) of the mothers and 2.8% (4/143) achieved HBeAg negativity, but none had HBsAg loss. At birth, HBsAg was detected in 13.9% (20/144) of newborns and none at post-partum week 28. Vertical transmission rates among infants were 0.7% (1/144, intention-to-treat) and 0% (per-protocol). No infants had birth defects. No serious adverse effects were reported in either mothers or infants. Breastfeeding did not increase the HBV infection rate among infants although mothers had viral rebound after TDF cessation.
CONCLUSIONS:

TDF for highly viraemic mothers was well tolerated and reduced vertical transmission of HBV in a real-world setting. There were no safety concerns during the postpartum 28-week follow-up. Registry number: Chinese Clinical Trial Registration No. ChiCTR-OIC-17010869.

© 2018 John Wiley & Sons Ltd.

PMID:
    30506691
DOI:
    10.1111/apt.15064

StephenW

Aliment Pharmacol Ther。 2018年12月2日doi：10.1111 / apt.15064。 [提前打印]
现实世界研究替诺福韦地索普西富马酸盐预防高病毒载量母亲的乙型肝炎传播。
Wang M1，Bian Q1，Zhu Y1，Pang Q1，Chang L1，Li R1，Tiongson BC2，Zhang H1，Pan CQ3。
作者信息

1
    首都医科大学附属北京佑安医院妇产科，北京
2
    纽约布鲁克林的宗教间医疗中心。
3
    纽约大学医学系消化内科，纽约大学朗格健康学院，纽约大学医学院，纽约市。

抽象
背景：

关于在实际环境中预防乙型肝炎病毒（HBV）垂直传播的替诺福韦地索普西富马酸盐（TDF）疗法的数据是有限的。
目的：

调查TDF在实际操作中防止HBV垂直传播。
方法：

乙型肝炎e抗原（HBeAg）阳性母亲HBV-DNA> 6 log10 IU / mL，在孕周24-33和分娩之间接受TDF，前瞻性登记并随访至产后第28周。所有婴儿均接受免疫预防。主要终点是TDF使用的安全性和母婴传播率。次要结果是分娩时母体HBV-DNA水平抑制（<200 000 IU / mL）和研究期间HBeAg和乙型肝炎表面抗原（HBsAg）血清学变化。
结果：

在147名入选的母亲中，143名开始TDF，143/144名婴儿完成了这项研究。分娩时，93.7％（134/143）的母亲达到HBV-DNA <200 000 IU / L.在治疗中，在8.4％（12/143）的母亲中观察到丙氨酸氨基转移酶（ALT）突然发作。 TDF停止后，ALT在母亲中增加7.7％（11/143），2.8％（4/143）实现HBeAg阴性，但没有HBsAg消失。出生时，HBsAg在13.9％（20/144）的新生儿中检测到，而在产后第28周没有检测到。在婴儿中，垂直传播率为0.7％（1/144，意向治疗）和0％（每个协议）。没有婴儿出生缺陷。母亲或婴儿均未出现严重不良反应。母乳喂养没有增加婴儿的HBV感染率，尽管母亲在TDF停止后有病毒反弹。
结论：

高度视网膜母亲的TDF耐受性良好，并且在真实环境中减少了HBV的垂直传播。在产后28周的随访期间没有安全问题。登记号：中国临床试验注册号ChiCTR-OIC-17010869。

©2018 John Wiley＆Sons Ltd.

结论：
    30506691
DOI：
    10.1111 / apt.15064