title: Risk of side effects associated with the use of nevirapine in treatment-naïve patients, with respect to gender and CD4 cell count.
abstract: OBJECTIVE
  A warning about the use of nevirapine (NVP) by its pharmaceutical manufacturer has been issued in which it has been recommended that NVP should not be prescribed in patients with increased risk of toxicity based on CD4 cut-offs and gender. The aim of this study was to determine whether these recommendations are of use in preventing side effects.
  
  
  METHODS
  This retrospective study included antiretroviral drug-naïve patients who started treatment with NVP. Patients were divided into two groups: those with high CD4 counts (H; women: CD4 count >250 cells/microL; men: CD4 count >400 cells/microL) and those with low CD4 counts (L; women: CD4 count <250 cells/microL; men: CD4 count <400 cells/microL).
  
  
  RESULTS
  A total of 142 patients were included in the study, 61 in the H group and 81 in the L group. Skin rash developed in 6.56% of patients [95% confidence interval (CI) 2.67-15.70%] in the H group and in 14.81% of patients (95% CI 8.72-24.17%) in the L group (P=0.18). Hepatotoxicity developed in 4.92% (95% CI 1.79-13.50%) and 6.17% (95% CI 2.73-13.66%) of patients with high and low CD4 cell counts, respectively (P=1.0).
  
  
  CONCLUSIONS
  The recommendations not to use NVP in drug-naïve patients at increased risk of toxicity on the basis of gender and CD4 cell count do not seem to be of use in preventing the occurrence of side effects. However, a small number of patients were included in this study, and hence the possibility cannot be excluded that the recommendations are appropriate in another clinical practice setting.
authors.affiliation: Department of Internal Medicine-Infectious Diseases, Hospital del Mar, Barcelona, Spain. hknobel@imas.imim.es
authors.forename: H
authors.initials: H
authors.lastname: Knobel
authors.forename: A
authors.initials: A
authors.lastname: Guelar
authors.forename: M
authors.initials: M
authors.lastname: Montero
authors.forename: A
authors.initials: A
authors.lastname: Carmona
authors.forename: S
authors.initials: S
authors.lastname: Luque
authors.forename: N
authors.initials: N
authors.lastname: Berenguer
authors.forename: A
authors.initials: A
authors.lastname: González
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects*; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury; D005076:Exanthema / Q000139:chemically induced*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D019829:Nevirapine / Q000009:adverse effects*; D012189:Retrospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects*; D012307:Risk Factors; D012737:Sex Factors
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine