title: Neurologic Outcomes in HIV-Exposed/Uninfected Infants Exposed to Antiretroviral Drugs During Pregnancy in Latin America and the Caribbean.
abstract: To evaluate antiretroviral (ARV) drug exposure and other factors during pregnancy that may increase the risk of neurologic conditions (NCs) in HIV-exposed/uninfected (HEU) infants. A prospective cohort study was conducted at 24 clinical sites in Latin America and the Caribbean. Data on maternal demographics, health, HIV disease status, and ARV use during pregnancy were collected. Infant data included measurement of head circumference after birth and reported medical diagnoses at birth, 6-12 weeks, and 6 months. Only infants with maternal exposure to combination ARV therapy (cART) (≥3 drugs from ≥2 drug classes) during pregnancy were included. Microcephaly, defined as head circumference for age z-score less than -2, and NC were evaluated for their association with covariates, including individual ARVs, using bivariable and logistic regression analyses. From 2002 to 2009, 1,400 HEU infants met study inclusion criteria. At least one NC was reported in 134 (9.6%; 95% confidence interval [CI]: 8.1-11.2), microcephaly in 105 (7.5%; 95% CI: 6.2-9.0), and specific neurologic diagnoses in 33 (2.4%; 95% CI: 1.6-3.3) HEU infants. Microcephaly and NC were not significantly associated with any specific ARV analyzed (p > 0.05). Covariates associated with increased odds of NC included male sex (odds ratio [OR] = 1.9; 95% CI: 1.3-2.8), birth weight <2.5 kg (OR = 3.1; 95% CI: 2.1-4.8), 1-min Apgar score <7 (OR = 2.5; 95% CI: 1.4-4.4), and infant infections (OR = 2.5; 95% CI: 1.5-4.1). No ARV investigated was associated with adverse neurologic outcomes. Continued investigation of such associations may be warranted as new ARVs are used during pregnancy and cART exposure during the first trimester becomes increasingly common.
authors.affiliation: 1 National Institute of Allergy and Infectious Diseases , Bethesda, Maryland.
authors.forename: Alicen B
authors.initials: AB
authors.lastname: Spaulding
authors.affiliation: 2 Westat , Rockville, Maryland.
authors.forename: Qilu
authors.initials: Q
authors.lastname: Yu
authors.affiliation: 3 Department of Neurology, Children's National Medical Center , Washington, District of Columbia.
authors.forename: Lucy
authors.initials: L
authors.lastname: Civitello
authors.affiliation: 4 Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo , São Paulo, Brazil .
authors.forename: Marisa M
authors.initials: MM
authors.lastname: Mussi-Pinhata
authors.affiliation: 5 Division of Immunology, School of Medicine, Federal University of Minas Gerais , Belo Horizonte, Brazil .
authors.forename: Jorge
authors.initials: J
authors.lastname: Pinto
authors.affiliation: 6 Hospital Geral de Nova Iguaçu , Rio de Janeiro, Brazil .
authors.forename: Ivete M
authors.initials: IM
authors.lastname: Gomes
authors.affiliation: 7 Instituto de Medicine Tropical "Daniel Alcides Carrion," University of San Marcos, Lima, Peru .
authors.forename: Jorge O
authors.initials: JO
authors.lastname: Alarcón
authors.affiliation: 8 Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
authors.forename: George K
authors.initials: GK
authors.lastname: Siberry
authors.affiliation: 2 Westat , Rockville, Maryland.
authors.forename: D Robert
authors.initials: DR
authors.lastname: Harris
authors.affiliation: 8 Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
authors.forename: Rohan
authors.initials: R
authors.lastname: Hazra
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D017691:Caribbean Region; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007843:Latin America; D008297:Male; D018811:Maternal Exposure; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced* / Q000453:epidemiology* / Q000473:pathology; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents