First trimester exposure to antiretroviral therapy and risk of birth defects.
BACKGROUND
Use of antiretroviral (ARV) drugs during pregnancy has been associated with an increased risk of birth defects, but the evidence remains inconclusive.


METHODS
We identified infants born to human immunodeficiency virus (HIV)-infected mothers between 1994 and 2009 using Tennessee Medicaid data linked to vital records. Maternal HIV status was based on diagnosis codes, prescriptions for ARVs and HIV-related laboratory testing. ARV exposure was identified from pharmacy claims. Birth defects diagnoses during the first year of life were identified from maternal and infant claims and vital records and were confirmed through medical record review. Multivariate logistic regression models were used to evaluate associations between first trimester ARV dispensing and birth defects.


RESULTS
Of 806 infants included in the study, 32 (4.0%) had at least 1 major birth defect, most (44%) in the cardiac system. There was no increased risk for infants exposed in the first trimester to ARVs compared with unexposed infants (odds ratio = 1.07; 95% confidence interval: 0.50-2.31). Of the 20 infants exposed to efavirenz, none had a birth defect (0%; 95% confidence interval: 0.0-13.2).


CONCLUSIONS
There was no significant association between first trimester ARV dispensing and the risk of birth defects in this Medicaid cohort of HIV-positive women.
From the *Department of Epidemiology; †Department of Biostatistics, Harvard School of Public Health, Boston, MA; and ‡Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN.
Kelesitse
K
Phiri
Sonia
S
Hernandez-Diaz
Kate B
KB
Dugan
Paige L
PL
Williams
Judith A
JA
Dudley
Astride
A
Jules
S Todd
ST
Callahan
George R
GR
Seage
William O
WO
Cooper
D000293:Adolescent; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D000013:Congenital Abnormalities / Q000453:epidemiology*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D008431:Maternal-Fetal Exchange; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011261:Pregnancy Trimester, First; D015995:Prevalence; D018570:Risk Assessment; D013714:Tennessee / Q000453:epidemiology; D055815:Young Adult
D044966:Anti-Retroviral Agents