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. 2014 Jul;33(7):741-6.
doi: 10.1097/INF.0000000000000251.

First trimester exposure to antiretroviral therapy and risk of birth defects

Kelesitse Phiri  1 , Sonia Hernandez-Diaz, Kate B Dugan, Paige L Williams, Judith A Dudley, Astride Jules, S Todd Callahan, George R Seage 3rd, William O Cooper
Affiliations

First trimester exposure to antiretroviral therapy and risk of birth defects

Kelesitse Phiri et al. Pediatr Infect Dis J. 2014 Jul.

Abstract

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.

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Conflict of interest statement

Potential conflicts of interest

SHD has consulted for Novartis, AstraZeneca and GSK. All other authors do not have any commercial or other association that might pose a conflict of interest

Figures

Figure 1
Figure 1
Validation and Classification of Malformations aThis was an infant with neonatal intensive care unit admission found to have an extra appendage (ligated in nursery) next to left fifth finger. bThe 2 minor malformations were: congenital ptosis (1) and atrial septal defect (1)
See this image and copyright information in PMC

References

    1. Gray GE, McIntyre JA. HIV and pregnancy. BMJ. 2007;334:950–3. - PMC - PubMed
    1. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. [Accessed December 7, 2012];Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. http://aidsinfo.nih.gov/guidelines/html/2/pediatric-arv-guidelines/0. [Table 17a – Table 17l]
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-infected Adults and Adolescents. Department of Health and Human Services; [Accessed December 7, 2012]. http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guide.... [Table 13]
    1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. [Accessed July 26, 2012];Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. 2011 Sep 14;:1–207. http://aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0.
    1. Fundaro C, Genovese O, Rendeli C, Tamburrini E, Salvaggio E. Myelomeningocele in a child with intrauterine exposure to efavirenz. AIDS. 2002;16:299–300. - PubMed

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