Experience with nevirapine in previously treated HIV-1-infected individuals

Objective: To assess the tolerability, virological, immunological and clini cal effects of nevirapine in the setting of a compassionate use programme i n pretreated HIV-infected individuals. Design: Retrospective observational cohort-study in 13 HIV-outpatient clini cs in The Netherlands. Methods: Main outcome measures: plasma HIV-1 RNA levels; CD4 cell counts; i ncidence 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 Nevira pine Named Patient Programme in The Netherlands were included. After 48 wee ks, 38% of patients had an HIV-1 RNA level below 1000 copies/ml. In multiva riate regression analysis, prior treatment with three or less nucleoside an alogue reverse transcriptase inhibitors, and a higher baseline CD4 cell cou nt was predictive of virological success. The median CD4 cell count remaine d stable over the 48 weeks. Eleven patients experienced a new AIDS-defining event. The total incidence of rash (including rash not leading to disconti nuation of nevirapine) was 13.9 and 6.4% of the patients discontinued nevir apine 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 thera py is safe and most likely to give sustained suppression of HIV-1 in patien ts that have been less extensively pretreated. CD4 cell counts remained sta ble despite the low rate of virological success, this also occurred in pati ents not concurrently using protease inhibitors (PIs). The incidence of nev irapine-related rash in PI-pretreated patients and especially in patients w ith undetectable HIV-1 RNA levels at the start of nevirapine treatment, is considerably lower than previously reported for antiretroviral-naive patien ts.