Antiretroviral Therapy Use During Pregnancy and the Risk of Small for Gestational Age Birth in a Medicaid Population.

BACKGROUND: Several studies have assessed the association between antiretroviral (ARV) therapy use during pregnancy and small for gestational age (SGA), but the evidence remains incompletely elucidated. METHODS: We linked data from Tennessee Medicaid files and vital records to evaluate pregnancies among human immunodeficiency virus (HIV)-infected women who delivered between 1994 and 2009. Maternal HIV status was defined based on diagnosis codes, ARV prescriptions and laboratory codes for CD4 count or HIV RNA assays. ARV use was identified from pharmacy claims. Risk of SGA (defined as birth weight below the 10th percentile for gestational age) and preterm birth was evaluated using logistic regression models. RESULTS: Four hundred and seventy-seven HIV-infected pregnant women contributing 604 singleton pregnancies were identified; 156 (26%) delivered SGA infants. ARV use during pregnancy was not associated with SGA [adjusted odds ratio: 0.93; 95% confidence interval (CI): 0.56-1.56] or preterm birth (adjusted odds ratio: 0.74; 95% CI: 0.42-1.32). Exposure to a protease inhibitor during the first trimester was associated with a lower risk of SGA (odds ratio: 0.54; 95% CI: 0.29-1.01) compared with non-exposure to a protease inhibitor throughout pregnancy. CONCLUSIONS: We observed no evidence of an association between ARV exposure during pregnancy and SGA delivery in this Medicaid cohort of HIV-infected women.

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.

CD4+ cell count testing more effective than HIV disease clinical staging in identifying pregnant and postpartum women eligible for antiretroviral therapy in resource-limited settings.

OBJECTIVE: Identifying antiretroviral therapy (ART) eligible HIV-infected (HIV+) pregnant women and rapidly initiating treatment preserves maternal health and prevents mother-to-child transmission. However, there have been few investigations of the performance of ART eligibility criteria in pregnant and postpartum women in resource-limited settings. METHODS: Pregnant and recently postpartum HIV+ women received CD4+ cell count and World Health Organization (WHO) clinical staging at enrollment into the mother-to-child transmission Plus Initiative. We compared immunologic and clinical criteria based on 2009 WHO ART treatment guidelines (WHO stage 3/4 or CD4+ cell count ≤350 cells/mm³) in identifying ART eligible women. RESULTS: Among 6036 women (62% antepartum, 38% postpartum), 2915 (48%) were ART eligible. Only 23% had WHO stage 3 or 4 disease, whereas 94% met CD4+ cell count criterion. Among 5356 women with WHO stage 1 or 2 disease, 2235 (42%) had CD4+ ≤350 cells per cubic millimeter. Change of CD4+ cell count ART eligibility threshold from ≤200 to ≤350 cells per cubic millimeter increased the proportion of ART eligible women from 21% to 45%. CONCLUSIONS: Use of CD4+ cell count criterion is superior to clinical staging in identifying pregnant and postpartum HIV+ women eligible for ART. Improving access to CD4+ testing is essential to identify and treat eligible women, optimizing maternal and child health outcomes.