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ADJUSTED ANALYSIS OF EFFECT OF IPT ON ADVERSE PREGNANCY OUTCOMES IN WOMEN WITH HIV
Gerhard B. Theron1, Nahida Chakhtoura2, Grace Montepiedra3, Lisa Aaron3, Patrick Jean-Philippe4, Adriana Weinberg5, Katie McCarthy6, Teacler Nematadzira7, Gaerolwe Mas
1Stellenbosch University, Tygerberg, South Africa,2NIH, Bethesda, MD, USA,3Harvard T.H. Chan School of Public Health, Boston, MA, USA,4DAIDS, NIAID, Bethesda, MD, USA,5University of Colorado Denver, Denver, CO, USA,6FHI 360, Durham, NC, USA,7University of Zimbabwe, Harare, Zimbabwe,8Botswana Harvard AIDS Institute Partnership, Gabarone, Botswana,9Makerere University–Johns Hopkins University Research Collaboration, Kampala, Uganda,10Johns Hopkins University School of Medicine, Baltimore, MD, USA
IMPAACT P1078 is a randomized non-inferiority study designed to compare safety of starting isoniazid preventive therapy (IPT) in pregnant women with HIV during pregnancy or after delivery. Previous unadjusted analyses showed that IPT during pregnancy increased the odds of the composite outcome of fetal demise, pre-term delivery (PTD), low birth weight (LBW) or congenital anomaly, but not individual outcomes. In this analysis we compared adverse pregnancy outcomes between study arms adjusting for important covariates.
HIV-infected pregnant women from 8 countries with TB incidence >60/100,000, were randomly assigned, with their infants, to initiate 28 weeks of IPT either during pregnancy (immediate) or at 12 weeks after delivery (deferred). Inclusion criteria were gestational age ≥14-34 weeks; weight ≥35 kg; no grade ≥2 liver enzyme elevations, acute hepatitis or Grade ≥1 peripheral neuropathy; no findings suggestive of TB; and no recent exposure to active TB cases. The composite and individual adverse pregnancy outcomes of interest and covariates are described in Table.1. Logistic regression of these outcomes were performed, stratified by gestational age (14-<24 vs 24-34 weeks).
This secondary analysis included 925 mother-infant pairs with pregnancy outcome data. All mothers were receiving antiretrovirals and 581(63%) had study entry HIV RNA
Adjusted analysis on the first composite outcome is consistent with previously reported unadjusted analysis, and shows that IPT effect on LBW outcome is significant. The results contextualize the risk/benefit ratio for IPT in pregnant women with HIV on ARVs living in high TB burden settings.