title: Effect of lopinavir/ritonavir monotherapy on quality of life and self-reported symptoms among antiretroviral-naive patients: results of the MONARK trial.
abstract: BACKGROUND
  Standard-of-care for HIV-infected patients consists of combining three antiretroviral drugs. However, other therapeutic strategies could be beneficial given long-term toxicity and quality of life (QOL) issues associated with taking multiple antiretroviral drugs for many years. In the prospective, open label, randomized, pilot monotherapy antiretroviral Kaletra (MONARK) trial among antiretroviral-naive patients, lopinavir/ritonavir (LPV/r) monotherapy was found to be less suppressive for HIV RNA than a standard triple-drug therapy of LPV/r plus zidovudine/lamivudine (on-treatment analysis after 48 weeks). We present data from the MONARK trial concerning QOL and patient-reported symptoms.
  
  
  METHODS
  Patient-reported symptoms were collected at baseline and at weeks 4, 12, 24 and 48 using a list of 22 symptoms. QOL was assessed at baseline, week 24 and week 48 using the six-domain World Health Organization QOL short form questionnaire for HIV-infected individuals including an evaluation of global health perception.
  
  
  RESULTS
  Patients treated with the standard triple-drug therapy reported significantly more symptoms over 48 weeks of treatment than patients treated with LPV/r monotherapy (incidence rate ratio [95% confidence interval] 1.3 [1.1, 1.6] P=0.001 and 1.4 [1.2, 1.7] P=0.0004 for the total number of symptoms and the number of symptoms causing discomfort, respectively). No baseline differences and no significant changes were observed in the six QOL scores. The percentage of patients with a positive perception of their global health status increased significantly in the monotherapy arm from 32% at baseline to 67% at week 48 (P<0.0001).
  
  
  CONCLUSIONS
  These results suggest that the number of self-reported symptoms could be used as a treatment-sensitive measure of patients' well-being in clinical trials.
authors.affiliation: NSERM U912 'Economic Et Social Sciences, Health Systems Et Societies', Marseilles, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Spire
authors.forename: Fabienne
authors.initials: F
authors.lastname: Marcellin
authors.forename: Isabelle
authors.initials: I
authors.lastname: Cohen-Codar
authors.forename: Philippe
authors.initials: P
authors.lastname: Flandre
authors.forename: François
authors.initials: F
authors.lastname: Boue
authors.forename: Pierre
authors.initials: P
authors.lastname: Dellamonica
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.forename: Michael
authors.initials: M
authors.lastname: Norton
authors.forename: Ngo
authors.initials: N
authors.lastname: Van Philippe
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Delfraissy
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects / Q000502:physiology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000627:therapeutic use; D061466:Lopinavir; D011744:Pyrimidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D018894:Reverse Transcriptase Inhibitors; D061466:Lopinavir; D019259:Lamivudine; D015215:Zidovudine; D019438:Ritonavir