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Long-Term Safety and Efficacy of Nevirapine-Based Approaches in HIV Type 1-Infected Patients

2006; Mary Ann Liebert, Inc.; Volume: 22; Issue: 4 Linguagem: Inglês

10.1089/aid.2006.22.321

1931-8405

Anna Bonjoch, Roger Paredes, Peré Domingo, Manel Cervantes, Enric Pedrol, Esteban Ribera, Lluís Force, Josep M. Llibre, Josep Vilaró, David Dalmau, Josep Cucurull, Jaume Mascaró, Àngels Masabeu, Núria Pérez‐Álvarez, Jordi Puig, Denise Cinquegrana, Bonaventura Clotet,

HIV/AIDS Research and Interventions

Using a multicenter, cross-sectional, observation study, the long-term safety, metabolic profile, and viral efficacy of nevirapine (NVP)-based approaches in HIV-1-infected patients treated for at least 2 years were assessed. For 4 months, all consecutive HIV-1-infected patients who had been receiving an NVP-containing regimen for at least 2 years were recruited. A total of 613 patients were included with a median follow-up period of 43 months (IQR: 31–51). At baseline, 24.5% (150 patients) were treatment naive, 41.5% (254 patients) switched for simplification purposes, and 34% (209 patients) were failing HAART. Increases by five times or more in AST/ALT values were observed in fewer than 2% of patients. Only 5.7% of all adverse events reported during the investigation were attributable to NVP. The percentage of patients with normal HDL cholesterol levels rose from 17.7% at baseline to 35.4% at the last visit. At the latest time point available for analysis, 76% of naive and 74% of those who had switched had HIV-1 RNA loads of <50 copies/ml, while 59% of salvage patients achieved this level of viral suppression. Factors associated with viral suppression at the latest visit were adequate adherence (OR: 2.58, 95% CI: 0.85–7.78, p < 0.001), first-line treatment (OR: 3.02, 95% CI: 1.52–6.00, p = 0.002), and baseline CD4 cells >400 cells/µl (OR: 2.34, 95% CI: 1.22–4.47, p = 0.010). Exposure to nevirapine for up to 4 years is safe. Liver toxicity is infrequent and generally mild. HDL cholesterol levels consistently increase over time and viral suppression is maintained.