Volume 62, Issue 2, pages 375–386, August 2015
Article has an altmetric score of 9
Potential conflict of interest: Dr. M.-H. Chang received grants from Gilead.
Supported by grants from the Center of Disease Control and the Ministry of Health and Welfare, Taiwan, and from Gilead Sciences, Inc. (Foster City, CA).
Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT Study): In addition to the authors, members of the Taiwan Study Group for the PreMIT Study include the following: Dr. Hsiao-Lin Hwa, Dr. Yi-Ning Su, Dr. Jin-Chung Shih, Dr. Kuang-Han Chao, Department of Obstetrics & Gynecology; Dr. Jia-Feng Wu, Dr. Hong-Yuan Hsu, Department of Pediatrics; Dr. Chun-Jen Liu, Dr. Tung-Hung Su, Department of Internal Medicine, National Taiwan University Hospital; Dr. Chin-Chuan Lin, Pei-Ying Lin, Wen-Rong Yang, Department of Obstetrics & Gynecology, Taiwan Adventist Hospital; Dr. Chun-Kuang Yang, Dr. Yin-Kuang Chang, Dr. Kuo-Hu Chen, Department of Obstetrics & Gynecology, Taipei Tzu Chi Hospital; Dr. Yu-Hung Lin, Dr. Heng-Ju Chen, Dr. Hun-Shan Pan, Department of Obstetrics & Gynecology; Dr. Beng-Huat Lau, Department of Pediatrics, Shin Kong Wu Ho-Su Memorial Hospital; Dr. Po-Jen Cheng, Dr. Yao-Lung Chang, Dr. Ho-Yen Chiueh, Dr. Tzu-Hao Wang, Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital, Linkou; Dr. Liang-Ming Lo, Dr. Chia-Lin Hsieh, Department of Obstetrics & Gynecology; Dr. Shao-Wen Cheng, Department of Pediatrics, Chang Gung Memorial Hospital, Taipei; Dr. Lung-Huang Lin, Department of Pediatrics, Cathay General Hospital, Taipei; Dr. Bo-Qing She, Department of Obstetrics & Gynecology; Dr. King-Jun Koh, Dr. Yi-Li Hung, Department of Pediatrics, Sijhih Cathay General Hospital; Dr. Fu-Shiang Peng, Department of Obstetrics & Gynecology; Dr. Yu-Cheng Lin, Department of Pediatrics, Far Eastern Memorial Hospital; Dr. Tzee-Chung Wu, Department of Pediatrics; Dr. Chih-Yao Chen, Department of Obstetrics & Gynecology, Taipei Veterans General Hospital; Dr. Chie-Pein Chen, Dr. Jian-Pei Huang, Department of Obstetrics & Gynecology; Dr. Chun-Yan Yeung, Department of Pediatrics, MacKay Memorial Hospital, Taipei; Chen-Ju Lin, Department of Obstetrics & Gynecology, MacKay Memorial Hospital, Tamsui; Dr. Wei-Tsung Chiu, Dr. Duo-Sheng Wang, Department of Obstetrics & Gynecology; Dr. Wen-Terng Lin, Department of Pediatrics, En Chu Kong Hospital; Dr. Kwei-Shuai Hwang, Department of Obstetrics & Gynecology, Tri-Service General Hospital; Dr. Ching-Feng Huang, Department of Pediatrics, Tri-Service General Hospital.
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, 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. (Hepatology 2015;62:375–386