title: Lopinavir/ritonavir plus nevirapine as a nucleoside-sparing approach in antiretroviral-experienced patients (NEKA study).
abstract: OBJECTIVE
  To compare the efficacy and safety of a nucleoside-sparing approach with a conventional highly active antiretroviral therapy (HAART) regimen in antiretroviral-experienced patients with prolonged viral suppression.
  
  
  METHODS
  Pilot study including 31 antiretroviral-experienced patients with HIV RNA <80 copies/mL. Subjects were randomly assigned to lopinavir/ritonavir (LPV/rtv) 400/100 mg BID plus nevirapine (NVP) 200 mg BID (NVP group, n = 16) or LPV/rtv plus the 2 previous NRTIs (NRTI group, n = 15). The primary endpoint was the percentage of subjects who maintained viral suppression at week 48. Changes in lipid metabolism, mitochondrial parameters, and LPV trough levels were also assessed.
  
  
  RESULTS
  All patients maintained viral suppression after 48 weeks. No subject discontinued therapy because of adverse events. HDL cholesterol increased by 28% at week 24 (P < 0.0001) and 10% after 48 weeks of follow-up (P = 0.319) in the NVP group. In the NRTI group, LDL cholesterol increased by 14% at week 48 (P = 0.076). Mitochondrial DNA/nuclear DNA ratio and mitochondrial respiratory chain complex IV activity showed a trend toward increasing in the NVP group. Mean (SD) LPV trough levels were 6340 (2129) ng/mL in the NRTI group and 5161 (2703) ng/mL in the NVP group (P = 0.140).
  
  
  CONCLUSIONS
  In antiretroviral-experienced subjects with sustained viral suppression, dual therapy with NVP plus LPV/rtv at standard dosage was as potent and safe as standard-of-care HAART at 48 weeks of follow-up. This approach may reduce mitochondrial toxicity and improve LPV/rtv-associated lipid abnormalities. The results of this pilot study support the study of this approach in a larger, randomized trial.
authors.affiliation: Department of Internal Medicine, Lluita contra la SIDA and Irsicaixa Foundations, Germans Trias i Pujol Hospital, Badalona, Universitat Autònoma de Barcelona, Barcelona, Spain. enegredo@ns.hugtip.scs.es
authors.forename: Eugènia
authors.initials: E
authors.lastname: Negredo
authors.forename: José
authors.initials: J
authors.lastname: Moltó
authors.forename: David
authors.initials: D
authors.lastname: Burger
authors.forename: Helene
authors.initials: H
authors.lastname: Côté
authors.forename: Oscar
authors.initials: O
authors.lastname: Miró
authors.forename: Josep
authors.initials: J
authors.lastname: Ribalta
authors.forename: Eva
authors.initials: E
authors.lastname: Martínez
authors.forename: Jordi
authors.initials: J
authors.lastname: Puig
authors.forename: Lidia
authors.initials: L
authors.lastname: Ruiz
authors.forename: Juliana
authors.initials: J
authors.lastname: Salazar
authors.forename: Sònia
authors.initials: S
authors.lastname: López
authors.forename: Julio
authors.initials: J
authors.lastname: Montaner
authors.forename: Celestino
authors.initials: C
authors.lastname: Rey-Joly
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D023241:Antiretroviral Therapy, Highly Active; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004361:Drug Tolerance; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000378:metabolism / Q000821:virology; D039682:HIV-Associated Lipodystrophy Syndrome / Q000209:etiology; D006801:Humans; D008055:Lipids / Q000097:blood; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D008928:Mitochondria / Q000187:drug effects / Q000378:metabolism; D019829:Nevirapine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011446:Prospective Studies; D011744:Pyrimidinones / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects; D012449:Safety
chemical_list: D019380:Anti-HIV Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D008055:Lipids; D011744:Pyrimidinones; D061466:Lopinavir; D019829:Nevirapine; D019438:Ritonavir