title: Lopinavir/ritonavir monotherapy as a simplification strategy in routine clinical practice.
abstract: OBJECTIVE
  The efficacy and safety of lopinavir/ritonavir monotherapy has been explored with promising results in well-controlled, randomized clinical trials. However, less information about its clinical usefulness in routine clinical practice is currently available. The objective of this study was to assess the effectiveness and safety of monotherapy with lopinavir/ritonavir as a treatment simplification strategy in HIV-infected patients with viral suppression outside a clinical trial setting.
  
  
  METHODS
  Fifty-one subjects who were switched to lopinavir/ritonavir monotherapy and whose HIV-1 RNA was <50 copies/mL were included in this retrospective study. Data were obtained from a prospectively compiled database. The primary endpoint was the percentage of subjects who maintained viral suppression after 48 weeks of follow-up. Secondary endpoints included the incidence of adverse events and changes in CD4+ T cell count and in lipid profile.
  
  
  RESULTS
  Two patients lost viral suppression, seven patients interrupted lopinavir/ritonavir monotherapy because of adverse events and four patients were lost before completing 48 weeks of follow-up. Thus, 38/40 (95.0%) patients maintained viral suppression when only subjects whose outcomes were available up to week 48 were considered and 38/51 (74.5%) patients maintained viral suppression when subjects who discontinued therapy or who were lost to follow-up were considered as treatment failures. The mean CD4+ T cell count significantly increased, from 541 (280) cells/mm3 at baseline to 609 (212) cells/mm3 at week 48 of follow-up (P=0.034). This increase was similar to that observed in the 48 weeks prior to lopinavir/ritonavir monotherapy (P=0.792). Although total cholesterol remained unchanged, there was a significant decrease in triglyceride levels during follow-up (P=0.029).
  
  
  CONCLUSIONS
  Monotherapy with lopinavir/ritonavir is safe and effective as a treatment simplification approach in HIV-1-infected patients with sustained viral suppression in routine clinical practice, particularly in those patients already receiving a lopinavir/ritonavir-based antiretroviral regimen.
authors.affiliation: Lluita contra la SIDA Foundation, Germans Trias i Pujol Hospital, Badalona, and Universidad Autónoma de Barcelona, Spain. jmolto@flsida.org
authors.forename: José
authors.initials: J
authors.lastname: Moltó
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Santos
authors.forename: Eugenia
authors.initials: E
authors.lastname: Negredo
authors.forename: Cristina
authors.initials: C
authors.lastname: Miranda
authors.forename: Sebastià
authors.initials: S
authors.lastname: Videla
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002784:Cholesterol / Q000097:blood; D016208:Databases, Factual; D023381:Endpoint Determination; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008055:Lipids / Q000097:blood; D061466:Lopinavir; D008297:Male; D011744:Pyrimidinones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification; D012189:Retrospective Studies; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D008055:Lipids; D011744:Pyrimidinones; D012367:RNA, Viral; D061466:Lopinavir; D002784:Cholesterol; D019438:Ritonavir