title: Early virologic suppression with three-class experienced patients: 24-week effectiveness in the darunavir outcomes study.
abstract: OBJECTIVE
  To evaluate 24-week virologic effectiveness of novel antiretroviral regimens for treatment of three-class experienced adult patients in a clinical practice setting following the US Food and Drug Administration approval of darunavir (DRV) for this population.
  
  
  METHODS
  A prospective cohort study.
  
  
  METHODS
  A single-center, academic HIV clinic.
  
  
  METHODS
  Three-class antiretroviral-experienced patients changing regimens between July 2006 and May 2008. Sociodemographic, psychosocial, and clinical characteristics were collected at baseline and during prospective follow-up.
  
  
  METHODS
  Plasma HIV viral load below 50 copies/ml and change in CD4 cell count at 24 weeks following regimen change. The Stanford Genotype Database was used to analyze HIV genotype resistance results and determine the number of active drugs in each regimen. Multivariate models and propensity score methods were employed to assess outcome measures.
  
  
  RESULTS
  Among 109 three-class experienced patients, who previously received an average of 10.5 prior antiretrovirals, 55% achieved viral load below 50 copies/ml at 24 weeks. Treatment strategy was classified as nonprotease inhibitor (n = 25), DRV/ritonavir (DRV/r) (n = 51), or other protease inhibitor (n = 33). The number of active drugs was not significantly different across strategies (P = 0.24). In multivariate analysis, patients treated with DRV/r (65%, odds ratio = 4.24 vs. nonprotease inhibitor strategy, 95% confidence interval = 1.28-14.06), raltegravir (65%, odds ratio = 3.10, 95% confidence interval = 1.12-8.62), or both were more likely to achieve viral load below 50 copies/ml.
  
  
  CONCLUSIONS
  Among antiretroviral-experienced patients changing regimens, those treated with DRV/r, raltegravir, or both were more likely to achieve a viral load below 50 copies/ml at 24 weeks. The effectiveness of these agents in routine clinical care mirrors their efficacy in clinical trials and has ushered in a new era in the therapy of three-class experienced patients.
authors.affiliation: Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: James A
authors.initials: JA
authors.lastname: McKinnell
authors.forename: Hui-Yi
authors.initials: HY
authors.lastname: Lin
authors.forename: Christa N
authors.initials: CN
authors.lastname: Nevin
authors.forename: James H
authors.initials: JH
authors.lastname: Willig
authors.forename: Graeme
authors.initials: G
authors.lastname: McFarland
authors.forename: Michael
authors.initials: M
authors.lastname: Genz
authors.forename: James L
authors.initials: JL
authors.lastname: Raper
authors.forename: Lori L
authors.initials: LL
authors.lastname: DeLaitsch
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Mrus
authors.forename: Winslow
authors.initials: W
authors.lastname: Klaskala
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mugavero
authors.forename: Michael S
authors.initials: MS
authors.lastname: Saag
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D018791:CD4 Lymphocyte Count; D000069454:Darunavir; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000627:therapeutic use*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods; D011446:Prospective Studies; D011760:Pyrrolidinones / Q000627:therapeutic use; D000068898:Raltegravir Potassium; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D017320:HIV Protease Inhibitors; D011760:Pyrrolidinones; D013449:Sulfonamides; D000068898:Raltegravir Potassium; D000069454:Darunavir