title: A randomized comparative 96-week trial of boosted atazanavir versus continued boosted protease inhibitor in HIV-1 patients with abdominal adiposity.
abstract: BACKGROUND
  Abdominal adiposity in HIV-1 patients initiating antiretroviral therapy may be part of a restoration-to-health phenomenon. Lipoatrophy is associated with long-term thymidine analogue therapy. Individual protease inhibitors (PIs) differ in their effects on lipids and insulin resistance.
  
  
  METHODS
  A randomized open-label multicentre 96-week trial compared changes in fat distribution in patients with suppressed HIV-1 RNA and abdominal adiposity, who either continued on their current twice-daily ritonavir-boosted PI (PI/r) or switched to once-daily boosted atazanavir (ATV/r). Treatment with two nucleoside reverse transcriptase inhibitors was unchanged. Body composition was assessed by dual-energy x-ray absorptiometry (DEXA) and abdominal computerized tomography (CT) scanning.
  
  
  RESULTS
  In total, 201 patients were randomized; 131 switched to ATV/r. Viral suppression (<50 copies/ml) was similarly maintained (93% ATV/r versus 89% PI/r). Mean changes from baseline in trunk-to-limb fat ratio were similar; difference estimates 0.03 (95% CI -0.06, 0.12; P=0.48 at week 48) and 0.02 (95% CI -0.10, 0.14; P=0.73 at week 96). More patients in the PI/r arm had a decrease of ≥20% in limb fat from baseline at week 96. Significantly greater reductions in proatherogenic lipids occurred following switch to ATV/r. Both treatment regimens were generally well-tolerated; the incidence of grade 3-4 treatment-related clinical adverse events was 34% among ATV/r recipients versus 4% of PI/r-treated patients.
  
  
  CONCLUSIONS
  Switching to ATV/r had no demonstrable benefit on abdominal adiposity. Maintenance of efficacy, less limb fat loss and marked reduction in proatherogenic lipids was observed with ATV/r compared with continuing a PI/r regimen.
authors.affiliation: St Stephens Centre, Chelsea and Westminster Hospital, London, UK. gm@moyleg.demon.co.uk
authors.forename: Graeme J
authors.initials: GJ
authors.lastname: Moyle
authors.forename: Jaime
authors.initials: J
authors.lastname: Andrade-Villanueva
authors.forename: Pierre-Marie
authors.initials: PM
authors.lastname: Girard
authors.forename: Andrea
authors.initials: A
authors.lastname: Antinori
authors.forename: Patricia
authors.initials: P
authors.lastname: Salvato
authors.forename: Johannes R
authors.initials: JR
authors.lastname: Bogner
authors.forename: Phillip
authors.initials: P
authors.lastname: Hay
authors.forename: Jesús
authors.initials: J
authors.lastname: Santos
authors.forename: Ludovic
authors.initials: L
authors.lastname: Astier
authors.forename: Miranda
authors.initials: M
authors.lastname: Pans
authors.forename: Agnes
authors.initials: A
authors.lastname: Balogh
authors.forename: Sophie
authors.initials: S
authors.lastname: Biguenet
mesh_terms: D050153:Abdominal Fat; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000069446:Atazanavir Sulfate; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage / Q000627:therapeutic use*; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D011725:Pyridines / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D009842:Oligopeptides; D011480:Protease Inhibitors; D011725:Pyridines; D000069446:Atazanavir Sulfate