Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2008 Aug 20;22(13):1633-40.
doi: 10.1097/QAD.0b013e328307a029.

Hematologic and hepatic toxicities associated with antenatal and postnatal exposure to maternal highly active antiretroviral therapy among infants

Woong Hwan Bae  1 , Carolyn Wester, Laura M Smeaton, Roger L Shapiro, Shahin Lockman, Kenneth Onyait, Ibou Thior, Max Essex
Affiliations
Randomized Controlled Trial

Hematologic and hepatic toxicities associated with antenatal and postnatal exposure to maternal highly active antiretroviral therapy among infants

Woong Hwan Bae et al. AIDS. .

Abstract

Objective: To assess hematologic and hepatic toxicities associated with in utero and breastfeeding exposure to maternal highly active antiretroviral therapy (HAART) among infants in Botswana.

Design: A nested cohort study within a randomized clinical trial (the Mashi Study). Laboratory toxicities among infants born to women who initiated HAART before delivery were compared with toxicities among those born to women who received zidovudine and a single dose of nevirapine or placebo in labor. Infants were randomized to breastfeed with extended zidovudine or to formula-feed.

Methods: Hemoglobin concentrations, absolute neutrophil and platelet counts, and alanine aminotransferase and aspartate aminotransferase levels were recorded from birth to 7 months of age in infants. Grade 3 and 4 toxicities were compared by infant antiretroviral exposure status.

Results: In-utero exposure to maternal HAART was associated with increased risk for neutropenia in infants up to 1 month of age; 21.7% of HAART-exposed infants were neutropenic, compared with 5.5% of the infants exposed to zidovudine (P < 0.01). However, neutropenia was no longer associated with antenatal exposure to HAART after 1 month of age. Postnatal exposure to HAART was not associated with hematologic or hepatic toxicities. Laboratory toxicities were clinically asymptomatic in all but one infant.

Conclusion: Exposure to maternal HAART in utero may increase the risk for infant neutropenia, particularly among breastfed infants, but the clinical significance of this finding is uncertain. The lack of association between exposure to HAART through breastfeeding and long-term toxicities in infants is reassuring but deserves study in larger cohorts.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study population selection scheme according to HAART status and assigned feeding strategy.
Figure 2
Figure 2
Progression of absolute neutrophil counts overtime in infants (A&B) and cumulative proportion of infants having experienced a grade 3 or 4 neutropenia (C&D) stratified by maternal HAART exposure (A&C) or by maternal HAART exposure and assigned feeding strategy (B&D). A complete blood count (CBC) was performed at birth, 1 month, 4 months, and 7 months of age for formula-fed (FF) infants, and every month between birth and 7 months for breastfed (BF) infants. Means at each age are shown, along with 1 SE above or below the mean as bars (A&B). The cumulative proportions over time are calculated from the Kaplan-Meier method (C&D). Numbers at the bottom indicate the number of infants tested at corresponding time points.
See this image and copyright information in PMC

References

    1. Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O’Sullivan MJ, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994;331:1173–1180. - PubMed
    1. Cooper ER, Charurat M, Mofenson L, Hanson IC, Pitt J, Diaz C, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr. 2002;29:484–494. - PubMed
    1. Brogly SB, Ylitalo N, Mofenson LM, Oleske J, Van Dyke R, Crain MJ, et al. In utero nucleoside reverse transcriptase inhibitor exposure and signs of possible mitochondrial dysfunction in HIV-uninfected children. AIDS. 2007;21:929–938. - PubMed
    1. Pacheco SE, McIntosh K, Lu M, Mofenson LM, Diaz C, Foca M, et al. Effect of perinatal antiretroviral drug exposure on hematologic values in HIV-uninfected children: An analysis of the women and infants transmission study. J Infect Dis. 2006;194:1089–1097. - PubMed
    1. Culnane M, Fowler M, Lee SS, McSherry G, Brady M, O’Donnell K, et al. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA. 1999;281:151–157. - PubMed

Publication types

MeSH terms