title: Atazanavir in pregnancy: impact on neonatal hyperbilirubinemia.
abstract: OBJECTIVE
  To study the impact on the neonate of maternal antiretroviral therapy with atazanavir (ATV).
  
  
  METHODS
  An observational study of 22 HIV-infected women receiving, for clinical indications, antiretroviral therapy with ATV 300 mg and ritonavir 100mg during pregnancy and their 23 HIV infants (including a twin pair).
  
  
  RESULTS
  Mothers had received ATV for a median duration of 19 months [range 3-49] by delivery. At delivery, plasma HIV-RNA was <40 copies/mL in all patients. Liver enzymes were normal in 19/22 patients, but one woman had grade 3-4 liver toxicity. Maternal serum bilirubin concentrations were above the upper limit of normal in most patients, with grade 3 toxicity in 5 patients. All but one woman had trough ATV concentrations during pregnancy above the minimum effective concentration. The median cord blood ATV concentration was 130 ng/mL [range<30-758]; the cord/maternal ratio was 21%. All neonates were born at term [median 38.2 weeks]. Three neonates had mildly elevated AST transaminase levels. Bilirubin concentrations at birth were significantly higher than maternal concentrations, with a median of 44 μm/L [range 24-129]; values on days 2-3 were 63 [8-212]. Five neonates had jaundice requiring phototherapy, without liver damage, and recovered without sequelae.
  
  
  CONCLUSIONS
  Neonates whose mothers were treated with ATV should be monitored for hyperbilirubinemia, which may be due to placental transfer of unconjugated bilirubin from the mother and/or a direct effect of transplacental ATV on bilirubin metabolism in the fetus.
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Louis Mourier Hospital, Department of Obstetrics and Gynecology, Colombes, France. laurent.mandelbrot@lmr.aphp.fr
authors.forename: Laurent
authors.initials: L
authors.lastname: Mandelbrot
authors.forename: Fabienne
authors.initials: F
authors.lastname: Mazy
authors.forename: Corinne
authors.initials: C
authors.lastname: Floch-Tudal
authors.forename: Françoise
authors.initials: F
authors.lastname: Meier
authors.forename: Elie
authors.initials: E
authors.lastname: Azria
authors.forename: Catherine
authors.initials: C
authors.lastname: Crenn-Hebert
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Treluyer
authors.forename: Evelyne
authors.initials: E
authors.lastname: Herinomenzanahary
authors.forename: Claudia
authors.initials: C
authors.lastname: Ferreira
authors.forename: Gilles
authors.initials: G
authors.lastname: Peytavin
mesh_terms: D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D000069446:Atazanavir Sulfate; D001663:Bilirubin / Q000097:blood; D015331:Cohort Studies; D005260:Female; D005312:Fetal Blood; D015658:HIV Infections / Q000188:drug therapy; D017320:HIV Protease Inhibitors / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D006801:Humans; D051556:Hyperbilirubinemia, Neonatal / Q000097:blood / Q000139:chemically induced*; D007231:Infant, Newborn; D007567:Jaundice, Neonatal / Q000097:blood / Q000139:chemically induced / Q000628:therapy; D008297:Male; D008431:Maternal-Fetal Exchange; D008499:Medical Records; D009842:Oligopeptides / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D010789:Phototherapy; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D011297:Prenatal Exposure Delayed Effects / Q000097:blood; D011725:Pyridines / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D012189:Retrospective Studies; D019438:Ritonavir / Q000627:therapeutic use
chemical_list: D017320:HIV Protease Inhibitors; D009842:Oligopeptides; D011725:Pyridines; D000069446:Atazanavir Sulfate; D019438:Ritonavir; D001663:Bilirubin