The effects on infants of potent antiretroviral therapy during pregnancy: a report from Spain.
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.
Bellón Cano
Jose Ma
JM
Unit of Paediatric Epidemiology and Biostatistics, Hospital General Universitario Gregorio Marańón, Madrid, Spain.
Sánchez-Ramón
Silvia
S
Ciria
Luis
L
León
Juan Antonio
JA
Gurbindo
Dolores
D
Fortuny
Claudia
C
Bertrán
José Ma
JM
Ruiz Contreras
Jesús
J
Ramos
José-Tomás
JT
Asensi
Oscar
O
Mur
Antonio
A
Resino
Rosa
R
Muñóz-Fernández
Ma Angeles
MA
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
D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D018894:Reverse Transcriptase Inhibitors