title: Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection.
abstract: OBJECTIVE
  To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers.
  
  
  METHODS
  This retrospective study included 45 pregnant patients with hepatitis B e antigen (+) chronic hepatitis B and HBV DNA levels > 10⁷ copies/mL who received TDF 300 mg/d from week 18 to 27 of gestation (n = 21). Untreated pregnant patients served as controls (n = 24). All infants received 200 IU of hepatitis B immune globulin (HBIG) within 24 h postpartum and 20 μg of recombinant HBV vaccine at 4, 8, and 24 wk. Perinatal transmission rate was determined by hepatitis B surface antigen and HBV DNA results in infants at week 28.
  
  
  RESULTS
  At week 28, none of the infants of TDF-treated mothers had immunoprophylaxis failure, whereas 2 (8.3 %) of the infants of control mothers had immunoprophylaxis failure (P = 0.022). There were no differences between the groups in terms of adverse events in mothers or congenital deformities, gestational age, height, or weight in infants. At postpartum week 28, significantly more TDF-treated mothers had levels of HBV DNA < 250 copies/mL and normalized alanine aminotransferase compared with controls (62% vs none, P < 0.001; 82% vs 61%, P = 0.012, respectively).
  
  
  CONCLUSIONS
  TDF therapy during the second or third trimester reduced perinatal transmission rates of HBV and no adverse events were observed in mothers or infants.
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Mustafa Kemal
authors.initials: MK
authors.lastname: Celen
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Duygu
authors.initials: D
authors.lastname: Mert
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Müzeyyen
authors.initials: M
authors.lastname: Ay
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Tuba
authors.initials: T
authors.lastname: Dal
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Safak
authors.initials: S
authors.lastname: Kaya
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Necmettin
authors.initials: N
authors.lastname: Yildirim
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Serda
authors.initials: S
authors.lastname: Gulsun
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Tunga
authors.initials: T
authors.lastname: Barcin
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Sevgi
authors.initials: S
authors.lastname: Kalkanli
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Mehmet Sinan
authors.initials: MS
authors.lastname: Dal
authors.affiliation: Mustafa Kemal Celen, Celal Ayaz, Department of Infectious Diseases, Faculty of Medicine, Dicle University, 21280 Yenişehir, Diyarbakir, Turkey.
authors.forename: Celal
authors.initials: C
authors.lastname: Ayaz
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006509:Hepatitis B / Q000175:diagnosis / Q000188:drug therapy* / Q000635:transmission; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007136:Immunoglobulins / Q000008:administration & dosage; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D011263:Pregnancy Trimester, Third; D012189:Retrospective Studies; D000068698:Tenofovir; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D017325:Hepatitis B Vaccines; D006513:Hepatitis B e Antigens; D007136:Immunoglobulins; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine; C045213:hepatitis B hyperimmune globulin
keywords: Chronic; Hepatitis B; Reverse transcriptase inhibitors; Tenofovir; Vertical transmission