title: Long-term (4 years) efficacy of lopinavir/ritonavir monotherapy for maintenance of HIV suppression.
abstract: OBJECTIVE
  Data are scarce on the long-term efficacy of lopinavir/ritonavir monotherapy for the maintenance of HIV suppression. Four years of results of patients randomized to monotherapy in the Only Kaletra (OK) pilot clinical trial are presented.
  
  
  METHODS
  Twenty-one HIV-infected patients with suppressed HIV replication (<50 copies/mL) for at least 6 months and without previous failure while receiving a protease inhibitor-based regimen started lopinavir/ritonavir monotherapy. Follow-up was performed within the OK pilot clinical trial during the first 2 years and according to routine clinical practice during the 3rd and 4th years.
  
  
  RESULTS
  Fourteen patients (67%) remain on monotherapy and with RNA <50 copies/mL (intention-to-treat analysis, with missing patients scored as failures). Five patients (24%) had virological rebound and all of them were successfully re-suppressed by adding two nucleosides. No major protease inhibitor mutations were found.
  
  
  CONCLUSIONS
  Our data support the long-term efficacy and safety of lopinavir/ritonavir monotherapy for the maintenance of HIV suppression, a finding that must be confirmed in larger studies.
authors.affiliation: Unidad HIV, Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain. pulidof@gmail.com
authors.forename: Federico
authors.initials: F
authors.lastname: Pulido
authors.forename: Rafael
authors.initials: R
authors.lastname: Delgado
authors.forename: Ignacio
authors.initials: I
authors.lastname: Pérez-Valero
authors.forename: Juan
authors.initials: J
authors.lastname: González-García
authors.forename: Pilar
authors.initials: P
authors.lastname: Miralles
authors.forename: Alberto
authors.initials: A
authors.lastname: Arranz
authors.forename: Asunción
authors.initials: A
authors.lastname: Hernando
authors.forename: José R
authors.initials: JR
authors.lastname: Arribas
mesh_terms: D000328:Adult; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D006678:HIV / Q000235:genetics / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D061466:Lopinavir; D008297:Male; D009154:Mutation; D011744:Pyrimidinones / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D019438:Ritonavir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D012367:RNA, Viral; D061466:Lopinavir; D019438:Ritonavir