HUEY-LING CHENCHIEN-NAN LEEChang C.-H.YEN-HSUAN NIMING-KWANG SHYUChen S.-M.Hu J.-J.Lin H.H.Zhao L.-L.Mu S.-C.Lai M.-W.Lee C.-L.Lin H.-M.Tsai M.-S.Hsu J.-J.DING-SHINN CHENKIN-WEI CHANMEI-HWEI CHANGSu Y.-N.JIN-CHUNG SHIHKUANG-HAN CHAOJIA-FENG WUHONG-YUAN HSUCHUN-JEN LIUTUNG-HUNG SULin C.-C.Lin P.-Y.Yang W.-R.Yang C.-K.Chang Y.-K.Chen K.-H.Lin Y.-H.Chen H.-J.Pan H.-S.Lau B.-H.Cheng P.-J.Chang Y.-L.Chiueh H.-Y.Wang T.-H.Lo L.-M.Hsieh C.-L.Cheng S.-W.Lin L.-H.She B.-Q.Koh K.-J.Hung Y.-L.Peng F.-S.Lin Y.-C.Wu T.-C.Chen C.-Y.Chen C.-P.Huang J.-P.Yeung C.-Y.Lin C.-J.Chiu W.-T.Wang D.-S.Lin W.-T.Hwang K.-S.Huang C.-F.Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT Study)2021-03-092021-03-0920150270-9139https://www.scopus.com/inward/record.uri?eid=2-s2.0-84938213859&doi=10.1002%2fhep.27837&partnerID=40&md5=7b49e5a5758ee092b3ed485b6e76aa0bhttps://scholars.lib.ntu.edu.tw/handle/123456789/551110The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother-to-infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)- and hepatitis B e antigen-positive pregnant women with HBV DNA ?7.5 log10 IU/mL. The mothers received no medication (control group, n=56, HBV DNA 8.22±0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, n=62, HBV DNA 8.18±0.47 log10 IU/mL) from 30-32 weeks of gestation until 1 month postpartum. Primary outcome was infant HBsAg at 6 months old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29±0.93 versus 8.10±0.56 log10 IU/mL, P<0.0001). Of the 121/123 newborns, the TDF group had lower rates of HBV DNA positivity at birth (6.15% versus 31.48%, P = 0.0003) and HBsAg positivity at 6 months old (1.54% versus 10.71%, P = 0.0481). Multivariate analysis revealed that the TDF group had lower risk (odds ratio=0.10, P = 0.0434) and amniocentesis was associated with higher risk (odds ratio 6.82, P = 0.0220) of infant HBsAg positivity. The TDF group had less incidence of maternal alanine aminotransferase (ALT) levels above two times the upper limit of normal for ?3 months (3.23% versus 14.29%, P = 0.0455), a lesser extent of postpartum elevations of ALT (P = 0.007), and a lower rate of ALT over five times the upper limit of normal (1.64% versus 14.29%, P = 0.0135) at 2 months postpartum. Maternal creatinine and creatinine kinase levels, rates of congenital anomaly, premature birth, and growth parameters in infants were comparable in both groups. At 12 months, one TDF-group child newly developed HBsAg positivity, presumably due to postnatal infection and inefficient humoral responses to vaccines. Conclusions: Treatment with TDF for highly viremic mothers decreased infant HBV DNA at birth and infant HBsAg positivity at 6 months and ameliorated maternal ALT elevations. ? 2015 by the American Association for the Study of Liver Diseases.[SDGs]SDG3alanine aminotransferase; creatine kinase; creatinine; hepatitis B surface antigen; hepatitis B vaccine; hepatitis B(e) antigen; tenofovir disoproxil; virus DNA; adenine; phosphonic acid derivative; tenofovir disoproxil; virus DNA; adult; alanine aminotransferase blood level; amniocentesis; antiviral therapy; area under the curve; Article; congenital malformation; controlled study; creatine kinase blood level; creatinine blood level; drug efficacy; drug safety; female; gestational age; hepatitis B; Hepatitis B virus; human; humoral immunity; incidence; infant; major clinical study; male; multicenter study; multivariate analysis; outcome assessment; pregnant woman; prematurity; priority journal; prospective study; puerperium; virus transmission; analogs and derivatives; controlled clinical trial; drug effects; follow up; Hepatitis B, Chronic; maternal age; newborn; patient selection; pregnancy; Pregnancy Complications, Infectious; pregnancy outcome; prevention and control; reference value; risk assessment; Taiwan; transmission; treatment outcome; vertical transmission; virus load; young adult; Adenine; Adult; DNA, Viral; Female; Follow-Up Studies; Gestational Age; Hepatitis B virus; Hepatitis B, Chronic; Humans; Infant, Newborn; Infectious Disease Transmission, Vertical; Male; Maternal Age; Multivariate Analysis; Organophosphonates; Patient Selection; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Outcome; Prospective Studies; Reference Values; Risk Assessment; Taiwan; Treatment Outcome; Viral Load; Young Adultjournal article10.1002/hep.27837258510522-s2.0-84938213859