title: Efficacy and safety of tenofovir disoproxil fumarate in pregnancy to prevent perinatal transmission of hepatitis B virus.
abstract: OBJECTIVE
  Perinatal transmission of hepatitis B virus still occurs despite immunoprophylaxis in approximately 9% of children from highly viraemic mothers. Antiviral therapy in this setting has been suggested, however with limited evidence to direct agent choice.
  
  
  METHODS
  We conducted a multi-centre, prospective, opt-in observational study of antiviral safety and efficacy in pregnant women with high viral load (>7 log IU/ml); lamivudine was used from 2007 to 2010 and tenofovir disoproxil fumarate (TDF) from late 2010. Outcomes of treated and untreated cohorts were compared.
  
  
  RESULTS
  120 women with 130 pregnancies used TDF (58), lamivudine (52 including four who switched due to TDF intolerance) and no therapy (20). 96% were HBeAg positive, with baseline viral load mean 7.8 log IU/ml (±0.72) and ALT median 25 U/L (18.75-33). Duration of antiviral theraphy before birth was mean 58 days (±19) TDF and 53 (±14) lamivudine. Viral load declined by 3.64 log IU/ml (±0.9) TDF and 2.81 log IU/ml (±1.33) lamivudine. Virologic failure (birth viral load >7 IU/ml) occurred in 3% and 18% respectively. Congenital abnormality rate and neonatal growth centiles were similar across cohorts. Perinatal transmission reduced significantly to 2% and 0% in TDF and lamivudine cohorts, compared with 20% in untreated.
  
  
  CONCLUSIONS
  TDF in this setting is safe, effective and more potent than lamivudine. Antiviral therapy did not adversely impact obstetric or infant parameters. More TDF intolerance occurred than expected. Perinatal transmission was significantly reduced in antiviral therapy cohorts.
authors.affiliation: Gastroenterology, Liverpool Hospital, Sydney, Australia.
authors.forename: Astrid-Jane
authors.initials: AJ
authors.lastname: Greenup
authors.affiliation: Gastroenterology, Liverpool Hospital, Sydney, Australia.
authors.forename: Pok Kern
authors.initials: PK
authors.lastname: Tan
authors.affiliation: Gastroenterology, Liverpool Hospital, Sydney, Australia.
authors.forename: Vi
authors.initials: V
authors.lastname: Nguyen
authors.affiliation: Gastroenterology, Liverpool Hospital, Sydney, Australia.
authors.forename: Anne
authors.initials: A
authors.lastname: Glass
authors.affiliation: Gastroenterology, Liverpool Hospital, Sydney, Australia.
authors.forename: Scott
authors.initials: S
authors.lastname: Davison
authors.affiliation: University of New South Wales, Sydney, Australia.
authors.forename: Ushmi
authors.initials: U
authors.lastname: Chatterjee
authors.affiliation: Storr Liver Unit, Westmead Millennium Institute and Westmead Hospital, University of Sydney, Westmead, NSW 2145, Australia.
authors.forename: Susan
authors.initials: S
authors.lastname: Holdaway
authors.affiliation: Storr Liver Unit, Westmead Millennium Institute and Westmead Hospital, University of Sydney, Westmead, NSW 2145, Australia.
authors.forename: Dev
authors.initials: D
authors.lastname: Samarasinghe
authors.affiliation: Victorian Infectious Diseases Reference Laboratory, Melbourne, VIC, Australia.
authors.forename: Kathy
authors.initials: K
authors.lastname: Jackson
authors.affiliation: Victorian Infectious Diseases Reference Laboratory, Melbourne, VIC, Australia.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Locarnini
authors.affiliation: Gastroenterology, Liverpool Hospital, Sydney, Australia; University of New South Wales, Sydney, Australia. Electronic address: Miriam.Levy@sswahs.nsw.gov.au.
authors.forename: Miriam T
authors.initials: MT
authors.lastname: Levy
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006509:Hepatitis B / Q000188:drug therapy / Q000517:prevention & control* / Q000635:transmission*; D006515:Hepatitis B virus / Q000502:physiology; D006801:Humans; D015994:Incidence; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use; D063065:Organophosphonates / Q000009:adverse effects* / Q000627:therapeutic use*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000517:prevention & control*; D011256:Pregnancy Outcome; D011446:Prospective Studies; D000068698:Tenofovir; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D063065:Organophosphonates; D019259:Lamivudine; D000068698:Tenofovir; D000225:Adenine
keywords: HBV; Lamivudine; Perinatal; Pregnancy; Tenofovir disoproxil fumarate/tenofovir; Transmission