Tenofovir Alafenamide Used Throughout Pregnancy Q-L Zeng1, G-M Li2, Y-H Feng3, Z-Q Li1, G-F Zhang4, J-H Xu5, Z-M Chen6, G-L in Chinese Active Chronic Hepatitis B Mothers: A Cui7, Y-H Zhou8 and Z-J Yu1

Multicenter Prospective Study 1 Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of University, Zhengzhou, , ; 2 Department of Hepatology, The Sixth People’s Hospital of Zhengzhou City, Zhengzhou, Henan, China; 3 Department of Hepatology, The Sixth People’s Hospital of Kaifeng City, Kaifeng, Henan, China; 4 Department of Infectious Scan to Diseases, The First Affiliated Hospital of Nanyang Medical College, Nanyang, Henan, China; 5 Department of Hepatology, The download the poster Introduction Fifth People’s Hospital of Anyang City, Anyang, Henan, China; 6 Department of Obstetrics, The First Affiliated Hospital of 1 , Zhengzhou, Henan, China; 7 Department of Clinical Laboratory, The First Affiliated Hospital of Data on tenofovir alafenamide (TAF) therapy for pregnant Zhengzhou University, Zhengzhou, Henan, China; and 8 Department of Experimental Medicine and Jiangsu Key Laboratory women with active chronic hepatitis B (CHB) are lacking. for Molecular Medicine, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu, China.

2 Aim 4 Results To investigate the safety and effectiveness of TAF administration Among 1516 assessed mothers, 60 were in active CHB mothers and their infants. enrolled. At TAF initiation, the mean age,

gestational age, alanine aminotransferase, and Method 3 HBV DNA levels were 29.6 (± 4.6) years, 1.0 (± In this multicenter prospective study, active CHB mothers treated with TAF were enrolled, infants received standard 13.7) weeks, 112.5 (± 93.2) U/L, and 4.6 (± 3.5)

immunoprophylaxis, and all were followed until at least log10 IU/ml, respectively. TAF was well tolerated postpartum month 7. The safety and effectiveness profiles were monitored. for mothers during a mean treatment duration of 82.2 (± 20) weeks and the most common 5 Conclusions maternal adverse event was nausea (20%).

TAF administered throughout pregnancy in active CHB mothers Notably, 1 (1.7%) mother who initiated TAF at was generally safe for both mothers and infants, and effectively gestational week 12 undergone induced prevented mother-to-child transmission of HBV. abortion at gestational week 23 due to fetal 6 Acknowledgements cleft lip and palate. Among 59 live infants, no The authors sincerely thank the pregnant mothers and their congenital defects or malformations were families for their cooperation regarding the on-treatment and follow-up evaluations. observed at birth, 43 (72.9%) infants received breast milk, and the most common abnormal 7 References condition was prolonged (neonatal) jaundice 1. Zeng QL, Yu ZJ, Ji F, et al. Tenofovir Alafenamide to Prevent Perinatal Hepatitis B Transmission: A Multicenter, Prospective, Observational Study. Clin Infect Dis. 2021; Online. (10.2%). The infants’ physical and neurological 2. Ding Y, Cao L, Zhu L, et al. Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study. Aliment Pharmacol Ther. development were normal at birth, 7 months, Viral hepatitis Qing-Lei Zeng 2020; 52: 1377-1386. and 12 months. The virologic breakthrough 8 Contact information occurred in 2 (3.3%) mothers. No infant was

Dr Qing-Lei Zeng, MD, PhD, E-mail: [email protected] infected with HBV at 7 months. PO-990 ILC2021