title: Tenofovir disoproxil fumarate for prevention of vertical transmission of hepatitis B virus infection by highly viremic pregnant women: a case series.
abstract: BACKGROUND
  Despite appropriate immunoprophylaxis, up to 10 % of infants born to highly viremic hepatitis B virus (HBV-DNA ≥ 7 log IU/mL) mothers are infected with HBV. Use of TDF to prevent vertical transmission (VT) by such mothers has not been evaluated.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of TDF in preventing VT from highly viremic HBV-infected mothers.
  
  
  METHODS
  Data were collected retrospectively from HBV mono-infected, hepatitis B e antigen (HBeAg) positive, pregnant women between 6/2008 and 11/2010. Cases enrolled were HBV mono-infected mothers who received TDF (300 mg orally once a day) in the third trimester. Those with pregnancy complications or an abnormal fetus on sonography were excluded from use of TDF. All infants received hepatitis B immunoglobulin and vaccination at birth and subsequently.
  
  
  RESULTS
  Eleven Asian mothers received TDF at the median gestational age of 29 (28-32) weeks and the median duration of TDF use before delivery was 10 (7-12) weeks. A significant reduction in serum HBV-DNA was achieved at delivery compared with baseline (mean 5.25 ± 1.79 vs. 8.87 ± 0.45 log(10) copies/mL, respectively; p < 0.01). Three had serum ALT levels more than 1.5 times the upper limit of normal and two of these normalized before delivery. The 11 infants were born with no obstetric complication or birth defects. Five infants were breastfed. All infants were hepatitis B surface antigen negative 28-36 weeks after birth.
  
  
  CONCLUSIONS
  Our preliminary data suggest that TDF use in the third trimester is safe, and effectively prevents VT of HBV from high viremic HBeAg-positive mothers.
authors.affiliation: Division of Liver Diseases, Department of Medicine, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY, USA.
authors.forename: Calvin Q
authors.initials: CQ
authors.lastname: Pan
authors.forename: Li-Jun
authors.initials: LJ
authors.lastname: Mi
authors.forename: Chalermrat
authors.initials: C
authors.lastname: Bunchorntavakul
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Karsdon
authors.forename: William M
authors.initials: WM
authors.lastname: Huang
authors.forename: Gaurav
authors.initials: G
authors.lastname: Singhvi
authors.forename: Marc G
authors.initials: MG
authors.lastname: Ghany
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004333:Drug Administration Routes; D005260:Female; D006509:Hepatitis B / Q000097:blood / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D010757:Phosphorous Acids; D011247:Pregnancy; D012189:Retrospective Studies; D014766:Viremia / Q000188:drug therapy*
chemical_list: C574165:9-(2-((bis(pivaloyloxymethoxy)phosphinoyl)methoxy)propyl)adenine; D000998:Antiviral Agents; D063065:Organophosphonates; D010757:Phosphorous Acids; D000410:Alanine Transaminase; D000225:Adenine