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.
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.
Giuliano
Marina
M
Department of Drug Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. giuliano@iss.it
Guidotti
Giovanni
G
Andreotti
Mauro
M
Pirillo
Maria F
MF
Villani
Paola
P
Liotta
Giuseppe
G
Marazzi
Maria Cristina
MC
Mancini
Maria Grazia
MG
Cusato
Maria
M
Germano
Paola
P
Loureiro
Sandra
S
Ceffa
Susanna
S
Regazzi
Mario
M
Vella
Stefano
S
Palombi
Leonardo
L
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
D019380:Anti-HIV Agents; D012367:RNA, Viral; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine