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Abstract
Efavirenz in pregnancy: maternal characteristics of women who become pregnant on EFV-containing regimen and neonatal effects
M.I. Gonzalez-Tome1, M. Fernandez-Ibieta2, J. Ramos Amador2, E. Muñoz Galligo3, C. Rojo3, O. Nieto3, L. Prieto2, S. Guillen2, I. Solis4, The Spanish cohort of HIV-infected mother -infant pairs
Objectives: To assess the rate of mothers who become pregnant on Efavirenz (EFV)-containing regimen. To evaluate the possible EFV-induced fetal effects.
Methods: A prospective cohort study was performed at 9 Spanish hospitals from 2000 to 2005.Mother-child pairs were followed following a standard protocol. Children were followed up until 3 years of life.
Results: 619 mothers were included. Baseline characteristics(median):age:32 years (16-44), 78% were Caucasians, mode of infection:(heterosexual (52%), intravenous drug abuse(IDU)(39%), C3 CDC category:13%.At entry: CD4: 452 cells/mm3 (11-1950),viral load: 2.8 log(1.7-6.3). Hepatitis C-coinfected: 43%; 31% were active smokers, 8% referred active illegal drug abuse, 2% alcohol consumption and 19% received methadone. 297(48%) had received antiretrovirals prior to gestation and 75 women (25%) were on EFV. Among them, 31 (41%) women became pregnant on EFV (rate: 90.9,CI 95% (60.9-135.6) per 1000 person-years). In 30 cases, EFV was switched (median exposure: 2months (1, 8),1 continued. Two mothers started EFV during pregnancy. There were no significant differences according to age and CD4 but mothers on EFV were more frequently in C3 category (P=0.001),referred more IDU (P=0.04) and viral load at entry was lower (P=0.008). 631 children (24 twins) were followed (52% boys; median gestational age: 38 weeks (24-43), weight at birth: 2815g (430, 4150).Birth defects were recorded in 101(16%).Eight of them(1.2%) were exposed to Efavirenz (7 at 1st trimester) .Defects were:4 renal dilatation (14 cases among children not exposed to EFV), 1 angiomatosis (5 among not exposed), 1 dermoid cyst,1 acetabular dysplasia,1 inguinal hernia. Gestational age and weight at birth were similar between children exposed or not to EFV.
Conclusions: In our cohort, almost 50% of women of child-bearing became pregnant on EFV-containing regimen. First trimester exposure is frequent. Although we have not recorded major congenital abnormalities, for women planning a pregnancy, EFV should be avoided as guidelines recommended and procreation counselling included.
AIDS 2008 - XVII International AIDS Conference
Abstract no.
CDB0207
Suggested Citation
"M.I.Gonzalez-Tome, et al.
Efavirenz in pregnancy: maternal characteristics of women who become pregnant on EFV-containing regimen and neonatal effects.
:
AIDS 2008 - XVII International AIDS Conference:
Abstract no.
CDB0207"
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