作者
Gonzague Jourdain, Nicole Ngo-Giang-Huong, Linda Harrison, Luc Decker, Woottichai Khamduang, Camlin Tierney, Nicolas Salvadori, Tim R Cressey, Wasna Sirirungsi, Jullapong Achalapong, Prapap Yuthavisuthi, Prateep Kanjanavikai, Orada P Na Ayudhaya, Thitiporn Siriwachirachai, Sinart Prommas, Prapan Sabsanong, Aram Limtrakul, Supang Varadisai, Chaiwat Putiyanun, Pornnapa Suriyachai, Prateung Liampongsabuddhi, Suraphan Sangsawang, Wanmanee Matanasarawut, Sudanee Buranabanjasatean, Pichit Puernngooluerm, Chureeratana Bowonwatanuwong, Thanyawee Puthanakit, Virat Klinbuayaem, Satawat Thongsawat, Sombat Thanprasertsuk, George K Siberry, Diane H Watts, Nahida Chakhtoura, Trudy V Murphy, Noele P Nelson, Raymond T Chung, Stanislas Pol, Nantasak Chotivanich
发表日期
2018/3/8
期刊
New England Journal of Medicine
卷号
378
期号
10
页码范围
911-923
出版商
Massachusetts Medical Society
简介
Background
Pregnant women with an elevated viral load of hepatitis B virus (HBV) have a risk of transmitting infection to their infants, despite the infants’ receiving hepatitis B immune globulin.
Methods
In this multicenter, double-blind clinical trial performed in Thailand, we randomly assigned hepatitis B e antigen (HBeAg)–positive pregnant women with an alanine aminotransferase level of 60 IU or less per liter to receive tenofovir disoproxil fumarate (TDF) or placebo from 28 weeks of gestation to 2 months post partum. Infants received hepatitis B immune globulin at birth and hepatitis B vaccine at birth and at 1, 2, 4, and 6 months. The primary end point was a hepatitis B surface antigen (HBsAg)–positive status in the infant, confirmed by the HBV DNA level at 6 months of age. We calculated that a sample of 328 women would provide the trial with 90% power to detect a difference of at least 9 percentage points in …
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G Jourdain, N Ngo-Giang-Huong, L Harrison, L Decker… - New England Journal of Medicine, 2018