Tenofovir Alafenamide for Pregnant Chinese Women With Active Chronic Hepatitis B: A Multicenter Prospective Study

作者：Qing‐Lei Zeng, Hongxu Zhang, Jiyuan Zhang, Shuo Huang, Wei-Zhe Li, Guangming Li, Yajie Pan, Ying-Hua Feng, Zhiqin Li, Guofan Zhang, Jiang‐Hai Xu, Wan‐Bao Lin, Guang‐Hua Xu, Na Liu, Guoqiang Zhang, Guotao Li, Wei Li, Yanli Zeng, Ning Song, Meng Wang, Dawei Zhang, Zhimin Chen, Guanglin Cui, Juan Li, Jun Lv, Yanmin Liu, Hongxia Liang, Chang-Yu Sun, Yi‐Hua Zhou, Zu‐Jiang Yu, Fu‐Sheng Wang · 发表于：Clinical Gastroenterology and Hepatology · 年份：2021 · DOI：10.1016/j.cgh.2021.12.012 · 被引用次数：29 · 研究领域：Hepatitis B Virus Studies、Hepatitis C virus research、HIV/AIDS drug development and treatment

Background & Aims Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking. Methods Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants' safety, hepatitis B surface antigen (HBsAg) status, and growth conditions. Results One hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log 10 IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF ...