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Virologic Control and Infant Outcomes among Pregnant Women Exposed to Different ART Regimens during Pregnancy
Esau Joao*1, G Calvet1, L Sidi1, J Menezes1, C Cunha1, M Cruz1, E Martins1, M D'Ippolito1, and K Nielsen-Saines2
1Hosp dos Servidores do Estado, Rio de Janeiro, Brazil and 2Univ of California, Los Angeles, US
Background: Use of ART during pregnancy significantly
reduces HIV-1 mother-to-child transmission (MTCT), but there is concern that
specific ART regimens may lead to adverse neonatal outcomes.
Methods: We compared maternal virologic responses to 3
distinct ART regimens used in prevention of MTCT and correlated findings with
infant outcomes: birth weight (BW) and
preterm births (PB). Regimens included HAART with nelfinavir (NFV) (R1 n = 78), HAART with nevirapine (NVP) (R2
n = 286), and zidovudine (ZDV) or
zidovudine+lamivudine (ZDV+3TC) (R3 n = 261). Multiple linear
regression was used for birth weight. Semiparametric
Cox proportional hazards models for low birth weight (LBW <2500 g) and
pre-term (<37 week) were created to adjust for potential
confounding variables. Kruskal-Wallis median test was used to assess exposure
time to ART and c2 test for viral load at delivery.
Results: Data were abstracted from 645 HIV+ pregnant women (from 850
delivering at a public hospital 1996-2005) who initiated ART during pregnancy. Median duration of ART exposure in
weeks was 15 for R1, 12 for R2, and 13.5 for R3. The median initial viral load
was R1 = 33000, R2 = 8150, and R3 = 3000 copies/mL. The proportion of
undetectable viral load at labor was 54% for R1, 66% for R2, and 38% for R3 (p <0.0001). Overall MTCT rate was
2.1%, with no statistical difference among the groups. Proportion of low birth weight and pre-term were 11
and 10% for R3, 15 and 9% for R2, and 17 and 16% for R1, with no statistical
difference. HAART was
significantly associated with lower birth weight, with an effect of –155.5 g
(–78.0, 95%CI –233 to 1), while for R1 x R2 a non-significant effect of –25.8 g
(95%CI –86.7 to 138.4) was detected. There was no increased risk of low birth
weight when comparing HAART vs non-HAART and R1 vs R2. For pre-term outcomes,
when comparing R1 vs R2 a significant effect RR = 2.2 (95%CI 1.1 to 4.2) was
found, but none was found when comparing HAART vs non-HAART.
Conclusions: HAART was associated with a slightly lower
birth weight than non-HAART. There was a tendency for NFV-containing HAART to
be associated with an increased risk of pre-term birth than NVP-containing
HAART. Virologic control was similar in both HAART groups.
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