Expected 8-Week Prenatal vs 12-Week Perinatal Tenofovir Alafenamide Prophylaxis to Prevent Mother-to-Child Transmission of Hepatitis B Virus: A Multicenter, Prospective, Open-Label, Randomized Controlled Trial

• Published in: The American journal of gastroenterology Vol. 120; no. 5; pp. 1045 - 1056
• Main Authors: Zeng, Qing-Lei, Zhou, Yi-Hua, Dong, Xiao-Ping, Zhang, Ji-Yuan, Li, Guang-Ming, Xu, Jiang-Hai, Chen, Zhi-Min, Song, Ning, Zhang, Hong-Xu, Chen, Ru-Yue, Lv, Xue-Yan, Huang, Shuo, Li, Wei-Zhe, Pan, Ya-Jie, Feng, Ying-Hua, Li, Zhi-Qin, Zhang, Guo-Fan, Lin, Wan-Bao, Zhang, Guo-Qiang, Li, Guo-Tao, Li, Wei, Zeng, Yan-Li, Zhang, Da-Wei, Cui, Guang-Lin, Lv, Jun, Liu, Yan-Min, Liang, Hong-Xia, Sun, Chang-Yu, Wang, Fu-Sheng, Yu, Zu-Jiang
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Wolters Kluwer 01.05.2025; Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
• Subjects: Adenine - administration & dosage; Adenine - analogs & derivatives; Adenine - therapeutic use; Adult; Alanine; Antibodies; Antigens; Antiviral Agents - administration & dosage; Antiviral Agents - therapeutic use; Clinical trials; Disease prevention; DNA, Viral; Drug dosages; Female; Hepatitis B; Hepatitis B - prevention & control; Hepatitis B - transmission; Hepatitis B virus - genetics; Humans; Infant; Infant, Newborn; Infections; Infectious Disease Transmission, Vertical - prevention & control; Jaundice; Mothers; Postpartum period; Pregnancy; Pregnancy Complications, Infectious - drug therapy; Prospective Studies; Tenofovir - administration & dosage; Tenofovir - analogs & derivatives; Tenofovir - therapeutic use; Vaccines; Womens health; Young Adult; Ireland; tenofovir alafenamide; hepatitis B virus; safety; efficacy; pregnancy; mother-to-child transmission
• ISSN: 0002-9270; 1572-0241; 1572-0241
• DOI: 10.14309/ajg.0000000000003122

INTRODUCTION:The course of maternal antiviral prophylaxis to prevent mother-to-child transmission of hepatitis B virus (HBV-MTCT) varies greatly, and it has not been demonstrated in a randomized controlled study.METHODS:In this multicenter, open-label, randomized controlled trial, eligible pregnant women with HBV DNA of 5.3-9.0 log10 IU/mL who received tenofovir alafenamide fumarate (TAF) from the first day of 33 gestational weeks to delivery (expected 8 week) or to 4 weeks postpartum (expected 12 week) were randomly enrolled at a 1:1 ratio and followed until 6 months postpartum. All infants received standard immunoprophylaxis (hepatitis B immunoglobulin and vaccine). The primary end point was the safety of mothers and infants. The secondary end point was the HBV-MTCT rate of infants at the age of 7 months.RESULTS:Among 119 and 120 intention-to-treat pregnant women, 115 and 116 women were followed until delivery, and 110 and 112 per-protocol mother-infant dyads in 2 groups completed the study. Overall, TAF was well tolerated, no one discontinued the therapy due to adverse events (0/239, 0%, 95% confidence interval [CI] 0%-1.6%), and no infant had congenital defects or malformations at delivery (0/231, 0%, 95% CI 0%-1.6%). The infants' physical development at birth (n = 231) and at 7 months (n = 222) was normal. Furthermore, 97.0% (224/231, 95% CI 93.9%-98.5%) of women achieved HBV DNA <5.3 log10 IU/mL at delivery. The intention-to-treat and per-protocol infants' HBV-MTCT rates were 7.1% (17/239, 95% CI 4.5%-11.1%) and 0% (0/222, 95% CI 0%-1.7%) at the age of 7 months. Comparatively, 15.1% (18/119, 95% CI 9.8%-22.7%) vs 18.3% (22/120, 95% CI 12.4%-26.2%) of women in the 2 groups had mildly elevated alanine aminotransferase levels at 3 months and 6 months postpartum, respectively (P = 0.507); notably, no one experienced alanine aminotransferase flare (0% [0/119, 95% CI 0%-3.1%] vs 0% [0/120, 0%-3.1%]).DISCUSSION:Maternal TAF prophylaxis to prevent HBV-MTCT is generally safe and effective, and expected 8-week prenatal duration is feasible. ClinicalTrials.gov, NCT04850950.