Infant outcomes after maternal antiretroviral exposure in resource-limited settings.

TitleInfant outcomes after maternal antiretroviral exposure in resource-limited settings.
Publication TypeJournal Article
Year of Publication2012
AuthorsNielsen-Saines K, Komarow L, Cu-Uvin S, Jourdain G, Klingman KL, Shapiro DE, Mofenson L, Moran L, Campbell TB, Hitti J, Fiscus S, Currier J
Corporate AuthorsACTG 5190/PACTG 1054 Study Team
JournalPediatrics
Volume129
Issue6
Paginatione1525-32
Date Published2012 Jun
ISSN1098-4275
KeywordsAnti-HIV Agents, Cohort Studies, Developing Countries, Female, Follow-Up Studies, Health Resources, HIV Infections, HIV-1, Humans, Infant, Infectious Disease Transmission, Vertical, Internationality, Pregnancy, Pregnancy Complications, Infectious, Prospective Studies, Treatment Outcome, Viral Load
Abstract

BACKGROUND AND OBJECTIVE: The impact of maternal antiretrovirals (ARVs) during pregnancy, labor, and postpartum on infant outcomes is unclear.

METHODS: Infants born to HIV-infected mothers in ARV studies were followed for 18 months.

RESULTS: Between June 2006 and December 2008, 236 infants enrolled from Africa (n = 36), India (n = 47), Thailand (n = 152), and Brazil (n = 1). Exposure to ARVs in pregnancy included ≥ 3 ARVs (10%), zidovudine/intrapartum ARV (81%), and intrapartum ARV (9%). There were 4 infant infections (1 in utero, 3 late postpartum) and 4 deaths with 1.8% mortality (95% confidence interval [CI], 0.1%-3.5%) and 96.4% HIV-1-free survival (95% CI, 94.0%-98.9%). Birth weight was ≥ 2.5 kg in 86%. In the first 6 months, Indian infants (nonbreastfed) had lowest median weights and lengths and smallest increases in growth. After 6 months, African infants had the lowest median weight and weight-for-age z scores. Infants exposed to highest maternal viral load had the lowest height and height-for-age z scores. Serious adverse events occurred in 38% of infants, did not differ by country, and correlated with less maternal ARV exposure. Clinical diagnoses were seen in 84% of Thai, 31% of African, and 9% of Indian infants. Congenital defects/inborn errors of metabolism were seen in 18 (7.6%) infants, of which 17 were Thai (11%: 95% CI, 6.7%-17.0%); none had first trimester ARV exposure.

CONCLUSIONS: Infant follow-up in large international cohorts is feasible and provides important safety and HIV transmission data following maternal ARV exposure. Increased surveillance increases identification of congenital/inborn errors.

DOI10.1542/peds.2011-2340
Alternate JournalPediatrics
PubMed ID22585772
PubMed Central IDPMC3362906
Grant List1 U01 AI068616 / AI / NIAID NIH HHS / United States
1 U01 AI069463-01 / AI / NIAID NIH HHS / United States
1 U01 AI069518 / AI / NIAID NIH HHS / United States
5 U01 AI069399-05 / AI / NIAID NIH HHS / United States
5 U01 AI069436-02 / AI / NIAID NIH HHS / United States
5 U01 AI069450 / AI / NIAID NIH HHS / United States
5 U01 AI41110 / AI / NIAID NIH HHS / United States
AI068632 / AI / NIAID NIH HHS / United States
AI68634 / AI / NIAID NIH HHS / United States
N01-DK-9-01 / DK / NIDDK NIH HHS / United States
N01-HD-3-3345 / HD / NICHD NIH HHS / United States
P30 AI050410 / AI / NIAID NIH HHS / United States
U01 AI046749 / AI / NIAID NIH HHS / United States
U01 AI068632 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
U01 AI069429 / AI / NIAID NIH HHS / United States
U01 AI069432 / AI / NIAID NIH HHS / United States
U01AI069512 / AI / NIAID NIH HHS / United States