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Laboratory Abnormalities Among HIV-Exposed, Uninfected Infants: IMPAACT Protocol P1025
Jennifer S Read1, Yanling Huo2, Kunjal Patel3
1Pediatric, Adolescent, and Maternal AIDS Branch, Center for Research for Mothers and Children, National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland.
Insights
Infant laboratory abnormalities were uncommon and decreased with age. Preterm infants exposed to antiretrovirals faced higher risks for certain lab issues, highlighting the need for monitoring.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Neonatal Health
Background:
- Infant laboratory abnormalities have been linked to antiretroviral drug exposure and trimethoprim/sulfamethoxazole (TMP/SMX).
- Understanding these risks is crucial for managing HIV-infected mothers and their infants.
Purpose of the Study:
- To investigate the incidence and risk factors for laboratory serious adverse events (SAEs) in HIV-uninfected infants born to HIV-infected mothers.
- To assess the impact of antiretroviral exposure and infant characteristics on laboratory outcomes.
Main Methods:
- Analysis of data from the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) Protocol P1025.
- Inclusion of HIV-uninfected, singleton infants with at least 6 months of follow-up, whose mothers received antiretrovirals during pregnancy.
Main Results:
- The study included 1524 infants; laboratory SAEs were infrequent and decreased with infant age.
- Common laboratory SAEs involved glucose, hemoglobin, absolute neutrophil count, and total lymphocyte count.
- Preterm birth and current antiretroviral use were strongly associated with laboratory SAEs.
Conclusions:
- The overall frequency of laboratory SAEs in infants was low and diminished with increasing age.
- Preterm infants demonstrated a higher risk for SAEs related to hemoglobin and total lymphocyte count.
Background:
Infant laboratory abnormalities have been associated with exposure to antiretrovirals and to trimethoprim/sulfamethoxazole (TMP/SMX).
Methods:
We analyzed data from International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) Protocol P1025, a prospective cohort study of human immunodeficiency virus type 1 (HIV)-infected women and their infants. Live-born, singleton, HIV-uninfected infants with at least 6 months of follow-up who represented the first pregnancy on study of HIV-infected mothers with at least 1 prenatal visit, CD4 count, and viral load during pregnancy and who used at least 1 antiretroviral during pregnancy were eligible for inclusion in this analysis.
Results:
The study population comprised 1524 infants. During the first 6 months of life, 7.4% of laboratory serious adverse events (SAEs) were related to glucose, 7.2% were related to hemoglobin, 8.7% were related to absolute neutrophil count, and 4.0% were related to total lymphocyte count. The likelihood of laboratory SAEs decreased with increasing age for hemoglobin, absolute neutrophil count, and glucose. Infant preterm birth and current receipt of antiretroviral(s) were the factors with the strongest associations with laboratory SAEs.
Conclusions:
The overall frequency of laboratory SAEs was low and decreased with age. Preterm infants are at higher risk of hemoglobin- and total lymphocyte count-related SAEs.
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