title: Long-term safety and efficacy of nevirapine-based approaches in HIV type 1-infected patients.
abstract: 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/microl (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.
authors.affiliation: Lluita contra la SIDA Found, AIDS Care Unit, Universitat Autònoma de Barcelona, Hospital Germans Trias i Pujol, Badalona. abonjocj@ns.hugtip.scs.es
authors.forename: Anna
authors.initials: A
authors.lastname: Bonjoch
authors.forename: Roger
authors.initials: R
authors.lastname: Paredes
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Manel
authors.initials: M
authors.lastname: Cervantes
authors.forename: Enric
authors.initials: E
authors.lastname: Pedrol
authors.forename: Esteve
authors.initials: E
authors.lastname: Ribera
authors.forename: Lluís
authors.initials: L
authors.lastname: Force
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
authors.forename: Josep
authors.initials: J
authors.lastname: Vilaró
authors.forename: David
authors.initials: D
authors.lastname: Dalmau
authors.forename: Josep
authors.initials: J
authors.lastname: Cucurull
authors.forename: Jaume
authors.initials: J
authors.lastname: Mascaró
authors.forename: Angels
authors.initials: A
authors.lastname: Masabeu
authors.forename: Núria
authors.initials: N
authors.lastname: Pérez-Alvarez
authors.forename: Jordi
authors.initials: J
authors.lastname: Puig
authors.forename: Denise
authors.initials: D
authors.lastname: Cinquegrana
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D016009:Chi-Square Distribution; D008076:Cholesterol, HDL / Q000097:blood; D002986:Clinical Trials as Topic; D018592:Cross-Over Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D008076:Cholesterol, HDL; D012367:RNA, Viral; D019829:Nevirapine