title: Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women.
abstract: OBJECTIVE
  To describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)-infected women during pregnancy and post partum.
  
  
  METHODS
  HIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery. Cord blood samples and matching maternal blood samples were taken at delivery. The data were collected in 2 studies: P1026 (United States) and PANNA (Europe). Pharmacokinetic parameters were calculated.
  
  
  RESULTS
  Eighteen women were included in the analysis. Most women (12; 67%) received 150 mg of maraviroc twice daily with a protease inhibitor, 2 (11%) received 300 mg twice daily without a protease inhibitor, and 4 (22%) had an alternative regimen. The geometric mean ratios for third-trimester versus postpartum maraviroc were 0.72 (90% confidence interval, .60-.88) for the area under the curve over a dosing interval (AUCtau) and 0.70 (0.58-0.85) for the maximum maraviroc concentration. Only 1 patient showed a trough concentration (Ctrough) below the suggested target of 50 ng/mL, both during pregnancy and post partum. The median ratio of maraviroc cord blood to maternal blood was 0.33 (range, 0.03-0.56). The viral load close to delivery was <50 copies/mL in 13 women (76%). All children were HIV negative at testing.
  
  
  CONCLUSIONS
  Overall maraviroc exposure during pregnancy was decreased, with a reduction in AUCtau and maximum concentration of about 30%. Ctrough was reduced by 15% but exceeded the minimum Ctrough target concentration. Therefore, the standard adult dose seems sufficient in pregnancy.
  
  
  BACKGROUND
  NCT00825929 and NCT000422890.
authors.affiliation: Department of Pharmacy.
authors.forename: Angela
authors.initials: A
authors.lastname: Colbers
authors.affiliation: UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences & School of Medicine, University of California San Diego.
authors.forename: Brookie
authors.initials: B
authors.lastname: Best
authors.affiliation: Department of Pharmacy Department of Pharmacology and Toxicology, Radboud university medical center, Nijmegen.
authors.forename: Stein
authors.initials: S
authors.lastname: Schalkwijk
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health.
authors.forename: Jiajia
authors.initials: J
authors.lastname: Wang
authors.affiliation: Maternal Child and Adolescent/Adult Center, University of Southern California School of Medicine, Los Angeles.
authors.forename: Alice
authors.initials: A
authors.lastname: Stek
authors.affiliation: Department of Infectious Diseases, Hospital Universitario Virgen de las Nieves Granada, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Hidalgo Tenorio
authors.affiliation: Chelsea and Westminster Hospital.
authors.forename: David
authors.initials: D
authors.lastname: Hawkins
authors.affiliation: Imperial College Healthcare NHS Trust, London, United Kingdom.
authors.forename: Graham
authors.initials: G
authors.lastname: Taylor
authors.affiliation: HIV/AIDS Research Department, Irmandade da Santa Casa de Misericordia de Porto Alegre, Brazil.
authors.forename: Regis
authors.initials: R
authors.lastname: Kreitchmann
authors.affiliation: Boston Children's Hospital, Harvard Medical School.
authors.forename: Sandra
authors.initials: S
authors.lastname: Burchett
authors.affiliation: Department of Infectious Diseases, Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Haberl
authors.affiliation: Department of Infectious Diseases, Saint-Pierre University Hospital, Brussels, Belgium.
authors.forename: Kabamba
authors.initials: K
authors.lastname: Kabeya
authors.affiliation: Department of Internal Medicine, St Elisabeth Ziekenhuis, Tilburg, The Netherlands.
authors.forename: Marjo
authors.initials: M
authors.lastname: van Kasteren
authors.affiliation: Maternal, Adolescent, and Pediatric Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Smith
authors.affiliation: UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences & School of Medicine, University of California San Diego.
authors.forename: Edmund
authors.initials: E
authors.lastname: Capparelli
authors.affiliation: Department of Pharmacy.
authors.forename: David
authors.initials: D
authors.lastname: Burger
authors.affiliation: Boston University School of Medicine, Massachusetts.
authors.forename: Mark
authors.initials: M
authors.lastname: Mirochnick
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001774:Blood Chemical Analysis; D003510:Cyclohexanes / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005060:Europe; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D000077592:Maraviroc; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D014230:Triazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D014481:United States; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D014230:Triazoles; D000077592:Maraviroc
keywords: HIV; MTCT; maraviroc; pharmacokinetics; pregnancy