Incidence and risk factors of nevirapine-associated skin rashes among HIV-infected patients with CD4 cell counts <250 cells/μL

Abstract

The objective of the study was to determine cumulative incidence and risk factors of nevirapine (NVP)-associated rashes that lead to NVP discontinuation among HIV-infected patients with CD4 <250 cells/microL. A retrospective cohort study was conducted among antiretroviral-naïve HIV-infected patients who had baseline CD4 <250 cells/microL and were initiated NVP-based antiretroviral therapy (ART) between January 2003 and October 2005. There were 910 patients with a mean age of 35.4 years and 43% were women. Median CD4 cell count was 27 cells/microL and median HIV RNA was 5.5 log copies/mL. Cumulative incidences of rashes at 0.5, 1, 2, 3 and 6 months after ART were 3.7%, 6.2%, 8.1%, 8.5% and 8.5%, respectively. By Kaplan-Meier analysis, the higher baseline CD4 cell counts had a higher probability of NVP-associated rashes (log-rank test, P=0.041). By Cox regression analysis, higher baseline CD4 cell count was associated with a higher incidence of rashes (hazard ratio=1.244, 95% confidence interval=1.045-1.482, for every 50 cells/microL increment of baseline CD4 stratum). In conclusion, NVP-associated skin rashes that lead to NVP discontinuation are common among HIV-infected patients with baseline CD4 <250 cells/microL. Despite the low baseline in this population, the higher number of baseline CD4 cells is continuously associated with a higher risk for skin rashes.

Severe antiretroviral‐associated skin reactions in South African patients: a case series and case–control analysis

“…An association between baseline CD4 count and severe skin reactions due to nevirapine has been found previously . We found no association between CD4 count and severe skin reactions, possibly due to relatively low baseline CD4 counts across both cases and controls.…”

A Model and Risk Score for Predicting Nevirapine-Associated Rash among HIV-infected Patients: In Settings of Low CD4 Cell Counts and Resource Limitation§

“…No association between gender and CD4 cell count and risk of NVP-associated rash were observed in the present study even though these two factors were consistently reported in some studies [11-16]. We did not find any association between gender and risk of rash in our previous study using the same cohort [15].…”

“…Rare but serious hypersensitivity reactions, Stevens-Johnson Syndrome and toxic epidermal necrolysis, had been reported [5, 9, 10]. Risk factors for NVP-associated rash were female gender including pregnant women [11-14], lower body weight [15], initiation of NVP at high CD4 cell counts [11, 12, 15, 16], pretreated with antiretroviral drugs less than 12 months [17], higher plasma NVP level [17], and genetic (human leukocyte antigen) [18, 19]. However, some factors may not be applicable to patients who were initiated NVP at low CD4 cell counts in resource-limited settings.…”

Use of In Vitro to In Vivo Extrapolation to Predict the Optimal Strategy for Patients Switching from Efavirenz to Maraviroc or Nevirapine

“…However, starting the switch with the full dose could increase the risk of adverse effects (including skin rash). However, if switching patients to nevirapine they should have an appropriate CD4 cell count, which should decrease the risk of skin rash [33]. Table 2 Maraviroc simulated average pharmacokinetics.…”