Tenofovir Alafenamide for Pregnant Chinese Women with Active Chronic Hepatitis B: A Multicenter Prospective Study
替诺福韦艾拉酚胺治疗中国孕妇慢性活动性乙型肝炎：一项多中心前瞻性研究
10.1016/j.cgh.2021.12.012
2021-12-10, Article
Abstract & Authors:展开
Abstract:收起
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 virological 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 log10 IU/ml, respectively. TAF was well tolerated, and the most common adverse event was nausea (29.1%) during a mean of two 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 group had comparable safety and effectiveness profiles.
CONCLUSIONS: TAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants.
First Authors:
Qing-Lei Zeng,Hong-Xu Zhang,Ji-Yuan Zhang,Shuo Huang,Wei-Zhe Li,Guang-Ming Li
Correspondence Authors:
Qing-Lei Zeng,Zujiang Yu,Fu-Sheng Wang
All Authors:
Qing-Lei Zeng,Hong-Xu Zhang,Ji-Yuan Zhang,Shuo Huang,Wei-Zhe Li,Guang-Ming Li,Ya-Jie Pan,Ying-Hua Feng,Zhi-Qin Li,Guo-Fan Zhang,Jiang-Hai Xu,Wan-Bao Lin,Guang-Hua Xu,Na Liu,Guo-Qiang Zhang,Guo-Tao Li,Wei Li,Yan-Li Zeng,Ning Song,Meng Wang,Da-Wei Zhang,Zhi-Min Chen,Guang-Lin Cui,Juan Li,Jun Lv,Yan-Min Liu,Hong-Xia Liang,Chang-Yu Sun,Yi-Hua Zhou,Zujiang Yu,Fu-Sheng Wang
