title: Adverse events in a cohort of HIV infected pregnant and non-pregnant women treated with nevirapine versus non-nevirapine antiretroviral medication.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Infectious Diseases and HIV Medicine, Department of Medicine, Drexel University College of Medicine, Philadelphia, Pennsylvania, United States of America. eaaron@drexelmed.edu
authors.forename: Erika
authors.initials: E
authors.lastname: Aaron
authors.forename: Mirjam-Colette
authors.initials: MC
authors.lastname: Kempf
authors.forename: Shannon
authors.initials: S
authors.lastname: Criniti
authors.forename: Ellen
authors.initials: E
authors.lastname: Tedaldi
authors.forename: Ed
authors.initials: E
authors.lastname: Gracely
authors.forename: Amy
authors.initials: A
authors.lastname: Warriner
authors.forename: Ritu
authors.initials: R
authors.lastname: Kumar
authors.forename: Laura H
authors.initials: LH
authors.lastname: Bachmann
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects* / Q000627:therapeutic use; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine