Authors: Monique M R de Maat Rob ter Heine Jan W Mulder Pieter L Meenhorst Albert T A Mairuhu Eric C M van Gorp Alwin D R Huitema Jos H Beijnen
Publish Date: 2003/08/12
Volume: 59, Issue: 5-6, Pages: 457-462
Abstract
To determine the incidence of rash in HIV1 infected individuals starting a nevirapinecontaining regimen in an unselected outpatient clinic population Possible risk factors including plasma concentrations of nevirapine were evaluated for their relationship with the occurrence of a rashThe occurrence of rash was extracted from the outpatient medical records or based on a prescription of the antihistaminic cetirizine as documented by the community pharmacy within the first 90 days of nevirapine use During regular visits to the clinic blood samples were collected for the determination of nevirapine plasma concentrations Possible risk factors such as demographics immunology virology clinical chemistry and antiretroviral pretreatment were collected at baseline for each patient In addition concomitantly used drugs during the nevirapinebased regimen were recorded The association between these factors and the occurrence of rash was studied Primary outcome was the onset of rash within the first 90 days after initiation of a nevirapinecontaining regimenData from 216 HIV1infected patients were used in this study Thirtyeight patients 176 developed a rash of some grade that led to discontinuation of nevirapine in seven patients 32 of the included patients The median time to occurrence of rash was 26 days interquartile range 17–46 days The multivariate analysis showed that patients pretreated with antiretroviral drugs less than 12 months before the initiation of a nevirapinecontaining regimen had a more than 25fold increased risk of developing rash Furthermore nevirapine plasma concentrations were also significantly related to the occurrence of rash A more than twofold increased risk for developing rash was observed for patients with nevirapine plasma concentrations above 53 mg/lThis is the first study demonstrating that patients with antiretroviral pretreatment less than 12 months and with nevirapine plasma concentrations above 53 mg/l during the first 90 days of treatment are at a higher risk for the development of rash It is therefore advised to monitor this group of patients carefully when initiating nevirapinecontaining therapy
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