title: Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus.
abstract: 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.
authors: Departments of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.|Medical Education and Bioethics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.|Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: Huey-Ling
authors: HL
authors: Chen
authors: Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: Chien-Nan
authors: CN
authors: Lee
authors: Medical Research, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: Chin-Hao
authors: CH
authors: Chang
authors: Departments of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: Yen-Hsuan
authors: YH
authors: Ni
authors: Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: Ming-Kwang
authors: MK
authors: Shyu
authors: Departments of Obstetrics and Gynecology, Taiwan Adventist Hospital, Taipei, Taiwan.
authors: Shih-Ming
authors: SM
authors: Chen
authors: Pediatrics, Taiwan Adventist Hospital, Taipei, Taiwan.
authors: Jen-Jan
authors: JJ
authors: Hu
authors: Departments of Internal Medicine, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan.
authors: Hans Hsienhong
authors: HH
authors: Lin
authors: Pediatrics, Buddhist Tzu-Chi General Hospital, Taipei, Taiwan.
authors: Lu-Lu
authors: LL
authors: Zhao
authors: Department of Pediatrics, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
authors: Shu-Chi
authors: SC
authors: Mu
authors: Departments of Pediatrics, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan.
authors: Ming-Wei
authors: MW
authors: Lai
authors: Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital, Linkou, Taiwan.
authors: Chyi-Long
authors: CL
authors: Lee
authors: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, New Taipei City, Taiwan.
authors: Hsien-Ming
authors: HM
authors: Lin
authors: Department of Obstetrics and Gynecology, Cathay General Hospital, Taipei, Taiwan.
authors: Ming-Song
authors: MS
authors: Tsai
authors: Department of Obstetrics and Gynecology, Taipei Chang Gung Memorial Hospital, Taipei, Taiwan.
authors: Jenn-Jeih
authors: JJ
authors: Hsu
authors: Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.|Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.|Genomics Research Center, Academia Sinica, Nankang, Taiwan.
authors: Ding-Shinn
authors: DS
authors: Chen
authors: Medical Research, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: K Arnold
authors: KA
authors: Chan
authors: Departments of Pediatrics, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.|Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: Mei-Hwei
authors: MH
authors: Chang
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006515:Hepatitis B virus / Q000187:drug effects*; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000635:transmission; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D008423:Maternal Age; D015999:Multivariate Analysis; D063065:Organophosphonates / Q000627:therapeutic use*; D018579:Patient Selection; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000517:prevention & control; D011256:Pregnancy Outcome; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D013624:Taiwan; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine