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1 Department of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
2 Primary Care Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
3 Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
4 Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
5 Medical Research, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
6 Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan
7 Department of Obstetrics and Gynecology, Taiwan Adventist Hospital, Taipei, Taiwan
8 Department of Pediatrics, Taiwan Adventist Hospital, Taipei, Taiwan
9 Departments of Internal Medicine, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan
10 Department of Pediatrics, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan
11 Department of Pediatrics, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
12 Department of Pediatrics, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan
13 Department of Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan
14 Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, New Taipei City, Taiwan
15 Department of Obstetrics and Gynecology, Cathay General Hospital, Taipei, Taiwan
16 Department of Obstetrics and Gynecology, Taipei Chang Gung Memorial Hospital, Taipei, Taiwan
17 Genomics Research Center, Academia Sinica, Nankang, Taiwan
*Correspondence author: Professor Mei-Hwei Chang, MD, Department of Pediatrics, National Taiwan University College of Medicine and Children's Hospital, Taipei 100, Taiwan, 17F, No. 8, Chung-Shan South Road, Tel: +886-2-2312-3456 ext. 71701, Fax: +886-2- 23114592, E-mail: [email protected]
The 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, multi-center trial, enrolled 118 hepatitis B surface and e antigen (HBsAg, HBeAg)-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 one month postpartum. Primary outcome was infant HBsAg at 6-month-old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29±0.93 vs 8.10±0.56 log10 IU/mL, p<0.0001). Of the 121/123 newborns, TDF group had a lower rate of HBV DNA positivity at birth (6.15% vs 31.48%, P=0.0003), and HBsAg positivity at 6-month-old (1.54% vs 10.71%, P=0.0481). Multivariate analysis revealed TDF group with lower risk (odds ratio 0.10; P=0.0434), amniocentesis with higher risk (odds ratio 6.82; P=0.0220) of infant HBsAg positivity. TDF group had less incidence of maternal ALT levels above 2X upper limit of normal (ULN) for ≥ 3 months (3.23% vs 14.29%, P=0.0455); a less extent of postpartum elevations of ALT (P=0.007) and a lower rates of ALT > 5X ULN (1.64% vs 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: TDF treatment for highly viremic mothers decreased infant HBV DNA at birth, infant HBsAg positivity at 6 months, and ameliorated maternal ALT elevations. This article is protected by copyright. All rights reserved.