Background: Several studies have shown a high prevalence of rash induced by nevirapine. However, there is little knowledge about the risk factors associated with nevirapine-induced rash. The aim of this study was to identify risk factors associated with the occurrence of rash during the treatment with nevirapine of HIV-infected patients.
Methods: A retrospective study was conducted in the dermatology department of Besançon university teaching hospital between November 1998 and September 2001. The study included all HIV-infected patients receiving HAART regimens that included nevirapine. The following data were collected: age, sex, CDC classification of HIV, CD4 and CD8 lymphocyte counts, plasma HIV RNA load, hepatitis B, C and cytomegalovirus serostatus, history of drug allergy, concomitant medication (other antiretroviral drugs, corticosteroids, antihistamines). Univariate analysis was performed using a Chi2 test or Fischer's test and Student's t test. Fischer's test and the Cox proportional hazards model were used in the multivariate analysis.
Results: During the study period, 101 HIV-infected patients (74 men and 27 women; mean age: 41.6 +/- 10.3 years) were treated with HAART regimens including nevirapine. Fourteen developed cutaneous drug-reactions attributable to nevirapine (13.86%). We observed 13 cases of maculopapular exanthema and 1 case of DRESS. In the univariate analysis, female gender (p=0.002), plasma HIV RNA load > 10,000 copies/ml (p=0.05), heterosexual transmission (p=0.002) and abacavir treatment (p=0.05) constituted risk factors associated with rash. In the multivariate analysis, only female gender (p<0.0001) and plasma HIV RNA load > 10,000 copies/ml (p=0.0007) were associated with rash.
Discussion: The results of this study confirm the high frequency of toxidermy associated with nevirapine therapy. The risk factors associated with occurrence of rash due to nevirapine therapy were female gender and plasma RNA > 10,000 copies/ml. Several studies showed absence of any protective effect of antihistamines and corticosteroids in preventing the cutaneous adverse reactions associated with nevirapine. The identification of risk factors closely associated with nevirapine-induced rash could help physicians determine new strategies for safer use of nevirapine in the HAART regimen.