Huey-Ling Chen1,2,3, Chien-Nan Lee4, Chin-Hao Chang5, Yen-Hsuan Ni1, Ming-Kwang Shyu3, Shih-Ming Chen6, Jen-Jan Hu7, Hans Hsienhong Lin8, Lu-Lu Zhao9, Shu-Chi Mu10, Ming-Wei Lai11, Chyi-Long Lee12, Hsien-Ming Lin13, Ming-Song Tsai14, Jenn-Jeih Hsu15, Ding-Shinn Chen3,16,17, K Arnold Chan5, Mei-Hwei Chang1,3. 1. Departments of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan. 2. Medical Education and Bioethics, 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. Departments of Obstetrics and Gynecology, Taiwan Adventist Hospital, Taipei, Taiwan. 7. Pediatrics, Taiwan Adventist Hospital, Taipei, Taiwan. 8. Departments of Internal Medicine, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan. 9. Pediatrics, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan. 10. Department of Pediatrics, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan. 11. Departments of Pediatrics, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan. 12. Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan. 13. Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, New Taipei City, Taiwan. 14. Department of Obstetrics and Gynecology, Cathay General Hospital, Taipei, Taiwan. 15. Department of Obstetrics and Gynecology, Taipei Chang Gung Memorial Hospital, Taipei, Taiwan. 16. Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan. 17. Genomics Research Center, Academia Sinica, Nankang, Taiwan.
Abstract
UNLABELLED: 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.
UNLABELLED: The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother-to-infanthepatitis 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 infantHBV DNA at birth and infant HBsAg positivity at 6 months and ameliorated maternal ALT elevations. (Hepatology 2015;62:375-386.
Authors: Norah A Terrault; Anna S F Lok; Brian J McMahon; Kyong-Mi Chang; Jessica P Hwang; Maureen M Jonas; Robert S Brown; Natalie H Bzowej; John B Wong Journal: Hepatology Date: 2018-04 Impact factor: 17.425