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Adverse events in a cohort of HIV infected pregnant and non-pregnant women treated with nevirapine versus non-nevirapine antiretroviral medication
Journal article   Open access

Adverse events in a cohort of HIV infected pregnant and non-pregnant women treated with nevirapine versus non-nevirapine antiretroviral medication

Erika Aaron, Mirjam-Colette Kempf, Shannon Criniti, Ellen Tedaldi, Ed Gracely, Amy Warriner, Ritu Kumar and Laura H Bachmann
PloS one, v 5(9), e12617
07 Sep 2010
PMID: 20838641
url
https://doi.org/10.1371/journal.pone.0012617View
Published, Version of Record (VoR) Open

Abstract

Pregnancy Complications, Infectious - virology Follow-Up Studies Anti-HIV Agents - adverse effects Humans Middle Aged Nevirapine - therapeutic use CD4 Lymphocyte Count Nevirapine - adverse effects Pregnancy Complications, Infectious - immunology Pregnancy Young Adult HIV Infections - immunology Pregnancy Complications, Infectious - drug therapy Adult Anti-HIV Agents - therapeutic use Female HIV Infections - drug therapy Retrospective Studies Cohort Studies
Predictors of adverse events (AE) associated with nevirapine use are needed to better understand reports of severe rash or liver enzyme elevation (LEE) in HIV+ women. AE rates following ART initiation were retrospectively assessed in a multi-site cohort of 612 women. Predictors of onset of rash or LEE were determined using univariate and multivariate analyses. Of 612 subjects, 152 (24.8%) initiated NVP-based regimens with 86 (56.6%) pregnant; 460 (75.2%) initiated non-NVP regimens with 67 (14.6%) pregnant. LEE: No significant difference was found between regimens in the development of new grade ≥2 LEE (p  =  0.885). Multivariate logistic regression demonstrated an increased likelihood of LEE with HCV co-infection (OR 2.502, 95% CI: 1.04 to 6, p =  0.040); pregnancy, NVP-based regimen, and baseline CD4 >250 cells/mm(3) were not associated with this toxicity. RASH: NVP initiation was associated with rash after controlling for CD4 and pregnancy (OR 2.78; 95%CI: 1.14-6.76), as was baseline CD4 >250 cells/mm(3) when controlling for pregnancy and type of regimen (OR 2.68; 95% CI: 1.19-6.02 p  =  0.017). CD4 at initiation of therapy was a predictor of rash but not LEE with NVP use in HIV+ women. Pregnancy was not an independent risk factor for the development of AEs assessed. The findings from this study have significant implications for women of child-bearing age initiating NVP-based ART particularly in resource limited settings. This study sheds more confidence on the lack of LEE risk and the need to monitor rash with the use of this medication.

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Collaboration types
Domestic collaboration
Web of Science research areas
Infectious Diseases
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