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Randomized Controlled Trial
. 2021 Apr 1;86(4):450-454.
doi: 10.1097/QAI.0000000000002586.

Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding

Affiliations
Randomized Controlled Trial

Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding

Sean S Brummel et al. J Acquir Immune Defic Syndr. .

Abstract

IMPAACT PROMISE 1077BF/FF was a sequentially randomized study of pregnant and postpartum women living with HIV to investigate the efficacy and safety of antiretroviral therapy (ART). This Maternal Health Component investigated efficacy for the risk of developing AIDS or death; and safety among women randomized to continue ART (CTART: N = 289) or discontinue ART (N = 268) after cessation of breastfeeding or after confirmation of infant infection. No AIDS-defining illnesses were reported during follow-up in either arm. Adverse events of grade 3 or higher were more frequent in the CTART arm [hazard ratio = 1.78, 95% confidence interval: (1.05 to 3.02), P-value = 0.03]. The difference in adverse events in the 2 groups was mostly driven by moderate weight loss for women on the CTART arm.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

FIGURE 1.
FIGURE 1.
CD4 cell counts cells/mm3 and log HIV-RNA over time with median, 25th and 75th percentiles; percentage of participants with (A) CD4 cell percentage <350 cells/mm3 and (B) HIV-RNA ≤400 copies. Both subfigures used the midpoint between visits to define the number of participants contributing to the data.

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