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Receipt of PI-containing HAART during Pregnancy and Adverse Pregancy Outcomes (Low Birth Weight, Preterm Birth) among HIV-1-infected Women in Latin America and the Caribbean: The NICHD International Site Development Initiative Perinatal Study
E Szyld1, R Gonin2, Eduardo Warley*1, P Cahn3, G Calvet4, G Duarte5, V Melo6,12, J Korelitz2, E Cardoso7, A Duran8, L Freimanis2, R Succi9, R de Souza10, D Chang2, and J Read11
1Hosp Diego Paroissien, Buenos Aires, Argentina; 2Westat, Rockville, MD, USA; 3Hosp J A Fernandez, Buenos Aires, Argentina; 4Hosp dos Servidores do Estado, Rio de Janeiro, Brazil; 5Univ of Sao Paulo Sch of Med, Ribeirao Preto, Brazil; 6Fed Univ of Minas Gerais Sch of Med, Belo Horizonte, Brazil; 7Hosp Conceição, Porto Alegre, Brazil; 8Hosp Gen de Agudos Jose Maria Ramos Mejia, Buenos Aires, Argentina; 9Federal Univ of Sao Paulo, Brazil; 10STD/HIV Clin, Caxias do Sul, Brazil; 11NICHD, NIH, DHHS, Bethesda, MD, USA; and 12Maternidade Odete Valadares, Belo Horizonte, Brazil
Background: There
have been conflicting reports, primarily from the United States and Europe, regarding maternal receipt of ART during
pregnancy and adverse outcomes among their infants (low birth weight and
preterm birth). We tested the hypothesis that receipt of HAART, including a
protease inhibitor (PI), during pregnancy was associated with an increased risk
of low birth weight (< 2500 g) and preterm birth (< 37 completed weeks of
gestation) among infants of HIV-1-infected women in Latin America and the
Caribbean.
Methods: We analyzed
data from a prospective cohort study of HIV-1-infected women and their infants
in Argentina, the Bahamas, Brazil,
and Mexico
(NISDI Perinatal Study) which began enrollment in September 2002. The study
population consisted of women enrolled as of June 1, 2004, with data regarding
receipt of ART during pregnancy and who delivered a live-born, singleton infant
with known birth weight and gestational age. Maternal ART regimens were
categorized according to the most complex regimen received during
pregnancy: group1 (zidovudine [ZDV] or 2
nucleoside reverse transcriptase inhibitors [NRTI]), group2 (2 NRTI + 1 PI), group3
(2 NRTI + 1 NNRTI), group4 (other). Covariates associated with low birth
weight and preterm birth (evaluated
using Fisher’s exact test for categorical items, t-test for continuous variables) with p ≤ 0.25 were included in multivariate logistic regression
analyses.
Results: As
of June 1, 2004, 711 women were enrolled in the cohort, and 569 subjects met
the inclusion criteria. The following analyses were restricted to 516 subjects
whose ART regimen was categorized in 1 of 3 groups. Incidence of low birth weight: group 1 (6 of 72; 8.3%), group 2 (37 of 233;
15.9%); group 3 (18 of 211; 8.5%). Women in group 2 were (adjusted OR = 1.9;
95% CI 0.7 to 4.6; p = 0.18), but those in group 3 were not (adjusted
OR = 0.7; 95% CI 0.3 to 2.0), more likely to have low birth weight infants (group1: reference). Incidence of preterm birth: group 1 (5 of 72; 6.9%), group 2 (26 of 232;
11.2%); group3 (13 of 211; 6.2%). Women in group 2 were (adjusted OR = 1.5; 95%
CI 0.5 to 4.1; p = 0.45), but those
in group3 were not (adjusted OR = 0.6; 95% CI 0.2 to 2.0), more likely to have
infants with preterm birth (group 1:
reference).
Conclusions: Among
HIV-1-infected women in Latin America and the Caribbean, receipt of a regimen
of 2 NRTI and 1 PI during pregnancy is associated with a non-statistically
significant increase in risk of low birth weight and preterm birth compared with
regimens containing only 1 or 2 NRTI.
Keywords: low birth weight; preterm; protease inhibitor
