怀孕期间的特诺福维尔和乙型肝炎病毒传播:随机临床试验
Calvin Q Pan1,2, Erhei Dai3, Zhongfu Mo4
1Guangzhou Medical Research Institute of Infectious Diseases, Center for Liver Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.
JAMA
|November 14, 2024
概括
在怀孕16周开始给B型肝炎病毒 (HBV) 含量较高的母亲服用特诺福维尔双酸盐 (TDF) 与28周开始的标准治疗相比,效果不差. 这一策略有效地防止母婴传播HBV,尤其是在HBIG无效的情况下.
科学领域:
- 肝病学
- 病毒学
- 妇产科
背景情况:
- 肝炎B病毒的母婴传播 (MTCT) 的标准预防包括从怀孕28周开始的母婴抗病毒预防以及婴儿疫苗接种和HBIG.
- 在许多资源有限的环境中,B型肝炎免疫球蛋白 (HBIG) 无法使用,因此需要采用替代策略.
研究的目的:
- 评估在怀孕16周开始使用特诺福维尔双酸盐 (TDF) 是否与预防高病毒性母体HBV MTCT的标准28周治疗方案相比较.
- 与标准治疗 (TDF在28周,婴儿疫苗接种和HBIG) 相比,评估TDF在怀孕16周与婴儿HBV疫苗接种的有效性.
主要方法:
- 一个非盲目的,随机的,非劣势性试验,涉及280名HBVDNA>20万IU/ml的孕妇.
- 参与者被随机分配,从怀孕16周或28周开始接受TDF.
- 主要结论是产后28周的MTCT率,通过可检测的HBVDNA或HBsAg阳性来定义.
主要成果:
- 在16周的TDF组中,MTCT率为0. 76%,而在28周的TDF组中为0% (按方案分析:0%对0%).
- 这种差异符合非劣质性标准 (90% CI<3%的上限).
- 与28周组 (6. 3%) 相比,16周TDF组的先天性缺陷率较低.
结论:
- 在怀孕16周开始的TDF与在高病毒性孕妇中预防HBV MTCT的标准28周疗程相比没有劣势.
- 在缺乏HBIG的地区,这种早期的TDF启动策略是一个可行的替代方案.
- 这些发现支持优化HBV预防方案,以改善母亲和婴儿的结果.
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