| Abstrakt: |
Objective To assess the tolerability, virological, immunological and clinical effects of nevirapine in the setting of a compassionate use programme in pretreated HIV-infected individuals.Design Retrospective observational cohort-study in 13 HIV-outpatient clinics in The Netherlands.Methods Main outcome measures: plasma HIV-1 RNA levels; CD4 cell counts; incidence of new AIDS-defining diseases; multivariate analysis of predictors for virological success; incidence of skin rashes.Results 187 HIV-infected individuals treated with nevirapine in the Nevirapine Named Patient Programme in The Netherlands were included. After 48 weeks, 38% of patients had an HIV-1 RNA level below 1000 copies/ml. In multivariate regression analysis, prior treatment with three or less nucleoside analogue reverse transcriptase inhibitors, and a higher baseline CD4 cell count was predictive of virological success. The median CD4 cell count remained stable over the 48 weeks. Eleven patients experienced a new AIDS-defining event. The total incidence of rash (including rash not leading to discontinuation of nevirapine) was 13.9 and 6.4% of the patients discontinued nevirapine because of rash. None of the 28 patients with undetectable HIV-1 RNA levels at baseline developed a rash.Conclusions We conclude that nevirapine when used as part of salvage therapy, is safe and most likely to give sustained suppression of HIV-1 in patients that have been less extensively pretreated. CD4 cell counts remained stable despite the low rate of virological success, this also occurred in patients not concurrently using protease inhibitors (PIs). The incidence of nevirapine-related rash in PI-pretreated patients and especially in patients with undetectable HIV-1 RNA levels at the start of nevirapine treatment, is considerably lower than previously reported for antiretroviral-naive patients. |
