title: Triple antiretroviral prophylaxis administered during pregnancy and after delivery significantly reduces breast milk viral load: a study within the Drug Resource Enhancement Against AIDS and Malnutrition Program.
abstract: BACKGROUND
  The administration of antiretroviral therapy to lactating women could represent a possible strategy to reduce postnatal HIV transmission. In this study, we assessed the effect of antiretroviral treatment on breast milk viral load and determined plasma and breast milk drug concentrations in pregnant women receiving highly active antiretroviral therapy (HAART).
  
  
  METHODS
  We studied 40 women receiving zidovudine, lamivudine, and nevirapine from 28 weeks of gestation to 1 month postpartum (group A) and 40 untreated pregnant women (group B). Blood and breast milk samples were collected at delivery and 7 days postpartum.
  
  
  RESULTS
  Women in group A had received a median of 85 days of therapy before delivery. Median breast milk concentrations of nevirapine, lamivudine, and zidovudine were 0.6, 1.8, and 1.1 times, respectively, those in maternal plasma. HIV RNA levels in breast milk were significantly lower in group A than in group B (median of 2.3 vs. 3.4 log at delivery and 1.9 vs. 3.6 log at day 7; P < 0.001 for both comparisons).
  
  
  CONCLUSIONS
  Antiretroviral drugs administered during the last trimester of pregnancy and after delivery reach levels similar to or higher than plasma concentrations in breast milk and can significantly reduce HIV RNA levels. Our data support the potential role of maternal HAART prophylaxis in reducing the risk of breast-feeding-associated transmission.
authors.affiliation: Department of Drug Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. giuliano@iss.it
authors.forename: Marina
authors.initials: M
authors.lastname: Giuliano
authors.forename: Giovanni
authors.initials: G
authors.lastname: Guidotti
authors.forename: Mauro
authors.initials: M
authors.lastname: Andreotti
authors.forename: Maria F
authors.initials: MF
authors.lastname: Pirillo
authors.forename: Paola
authors.initials: P
authors.lastname: Villani
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Liotta
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Marazzi
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Mancini
authors.forename: Maria
authors.initials: M
authors.lastname: Cusato
authors.forename: Paola
authors.initials: P
authors.lastname: Germano
authors.forename: Sandra
authors.initials: S
authors.lastname: Loureiro
authors.forename: Susanna
authors.initials: S
authors.lastname: Ceffa
authors.forename: Mario
authors.initials: M
authors.lastname: Regazzi
authors.forename: Stefano
authors.initials: S
authors.lastname: Vella
authors.forename: Leonardo
authors.initials: L
authors.lastname: Palombi
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D006678:HIV / Q000235:genetics / Q000302:isolation & purification*; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000635:transmission* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D008895:Milk, Human / Q000737:chemistry / Q000821:virology*; D019829:Nevirapine / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D010865:Pilot Projects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000821:virology; D011263:Pregnancy Trimester, Third; D012367:RNA, Viral / Q000032:analysis; D018119:Stavudine / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D015215:Zidovudine / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine