title: The effects on infants of potent antiretroviral therapy during pregnancy: a report from Spain.
abstract: BACKGROUND
  The purpose of our study was to assess the effects on infants of protease inhibitor (PI)-based antiretroviral therapy (ART) given to their HIV-positive mothers during pregnancy.
  
  
  METHODS
  A multicenter observational study was carried out at 11 centers in Spain, involving 124 HIV-1-infected pregnant women under ART and their infants. The mothers were classified according to the ART protocols used during pregnancy into two groups: group A, 52 women with > or =2 nucleoside reverse transcriptase inhibitors (NRTI) with or without NNRTI, for a mean time of 4.7+/-2.2 months; and group B, 72 women on protease inhibitor (PI)-based regimens for 5.4+/-2.6 months.
  
  
  RESULTS
  Maternal therapy was well tolerated, with no serious adverse effects on pregnancy course. No newborn was infected with HIV-1. There were two deaths at birth (group B), both with extreme prematurity. Among the 126 ART-exposed infants (4 siblings), the most common toxicity was anemia (29%), without significant differences between the two groups. Low birthweight and prematurity were also common (21% and 14%, respectively).
  
  
  CONCLUSIONS
  Optimal management of HIV-1 infection in women, regardless of their pregnancy status, can be recommended in more developed countries, without adverse effects on pregnancy outcome, and dramatically decreasing vertical transmission. HAART with PI versus potent ART during pregnancy was effective and safe for infants throughout the 12-month follow-up. In the light of recent advances in anti-HIV-1 pregnancy therapy, the long-term safety of these prophylactic and therapeutical strategies should be studied.
authors.affiliation: Unit of Paediatric Epidemiology and Biostatistics, Hospital General Universitario Gregorio Marańón, Madrid, Spain.
authors.forename: Jose Ma
authors.initials: JM
authors.lastname: Bellón Cano
authors.forename: Silvia
authors.initials: S
authors.lastname: Sánchez-Ramón
authors.forename: Luis
authors.initials: L
authors.lastname: Ciria
authors.forename: Juan Antonio
authors.initials: JA
authors.lastname: León
authors.forename: Dolores
authors.initials: D
authors.lastname: Gurbindo
authors.forename: Claudia
authors.initials: C
authors.lastname: Fortuny
authors.forename: José Ma
authors.initials: JM
authors.lastname: Bertrán
authors.forename: Jesús
authors.initials: J
authors.lastname: Ruiz Contreras
authors.forename: José-Tomás
authors.initials: JT
authors.lastname: Ramos
authors.forename: Oscar
authors.initials: O
authors.lastname: Asensi
authors.forename: Antonio
authors.initials: A
authors.lastname: Mur
authors.forename: Rosa
authors.initials: R
authors.lastname: Resino
authors.forename: Ma Angeles
authors.initials: MA
authors.lastname: Muñóz-Fernández
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections; D006679:HIV Seropositivity; D015497:HIV-1 / Q000378:metabolism; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious; D011256:Pregnancy Outcome; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D013030:Spain; D013997:Time Factors
chemical_list: D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D018894:Reverse Transcriptase Inhibitors