Vijay Gayam, MD1, Dan Wang, BS2, Bryan Chen, BS3, Calvin Q. Pan, MD4
1Interfaith Medical Center, Brooklyn, NY; 2New Discovery LLC, Flushing, NY; 3University of California, Flushing, NY; 4New York University Langone Medical Center, New York, NY
Introduction: Maternal TDF treatment during the third trimester has been shown to reduce perinatal transmission of the hepatitis B virus (HBV) in highly viremic women in several RCTs. However, the data is limited on the effectiveness of TDF in the real-world setting. With this real-world study, we aimed to assess the efficacy and safety of TDF therapy for these mothers in a single center in the US.
Methods: All Hepatitis B e-antigen positive mothers with HBV DNA >6log10 copies/mL who received TDF in the third trimester and delivered from July 2010 to September 2018 were retrospectively analyzed. All infants received hepatitis B immunoglobulin and vaccination at birth and subsequently. Primary endpoints were the safety of TDF use and mother-to-child transmission rates. Secondary outcomes were maternal HBV DNA level suppression at delivery.
Results: Among the 75 patients enrolled, the mean (±SD) age of the patients was 30.47±4.49 years, mean (± SD) gestational age was 37.87±2.95 weeks, and the mean (±SD) treatment duration before delivery was 9.60±3.36 weeks. A significantly lower level of the mean (± SD) serum HBV DNA was achieved at delivery vs. baseline (4.2 ± 1.2 vs. 7.6 ± 0.80 log10 copies/mL, respectively; p- < 0.01). Additionally, 80% (60/75) of mothers achieved HBV DNA < 6log10 copies/mL at delivery. The median (Interquartile range) alanine aminotransferase (ALT) level before treatment was 26 (20) IU/L, and at delivery was 27 (20) IU/L respectively. Vertical transmission rate among infants was 0%, and all infants were hepatitis B surface antigen negative between 28 -52 weeks after birth. Fatigue was the most common complaint reported by 52% (39/75) of mothers. No infants had a birth defect. On treatment, ALT flares were observed in 4.5% (6/75) of mothers.
Discussion: In this US cohort of real-world practice, TDF therapy for highly viremic mothers was well tolerated and reduced vertical transmission effectively. No severe adverse effects were reported in both mothers and infants. Our study supports the use of TDF treatment for highly viremic mothers in a real-world setting.
Citation: Vijay Gayam, MD; Dan Wang, BS; Bryan Chen, BS; Calvin Q. Pan, MD. P2468 - TENOFOVIR DISOPROXIL FUMARATE (TDF) TO PREVENT HEPATITIS B TRANSMISSION IN MOTHERS WITH HIGH VIRAL LOAD IN A REAL WORLD U.S. COHORT. Program No. P2468. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.