Long-term safety and efficacy of nevirapine-based approaches in HIV type 1-infected patients.
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.
Bonjoch
Anna
A
Lluita contra la SIDA Found, AIDS Care Unit, Universitat Autònoma de Barcelona, Hospital Germans Trias i Pujol, Badalona. abonjocj@ns.hugtip.scs.es
Paredes
Roger
R
Domingo
Pere
P
Cervantes
Manel
M
Pedrol
Enric
E
Ribera
Esteve
E
Force
Lluís
L
Llibre
Josep M
JM
Vilaró
Josep
J
Dalmau
David
D
Cucurull
Josep
J
Mascaró
Jaume
J
Masabeu
Angels
A
Pérez-Alvarez
Núria
N
Puig
Jordi
J
Cinquegrana
Denise
D
Clotet
Bonaventura
B
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
D019380:Anti-HIV Agents; D008076:Cholesterol, HDL; D012367:RNA, Viral; D019829:Nevirapine