Switch studies in virologically suppressed patients

Switch to ATV/r monotherapy
MODAt
Original article : AIDS. 2014 Sep 24;28(15):2269-79 - A Castagna & J Antimicrob Chemother. 2016 Jun;71(6):1637-42 - L Galli
Last update : 18/07/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy with ATV/r + 2 NRTI
    • Inferiority more pronounced in those with
      • Pre-ART HIV RNA > 100 000 c/mL
      • Nadir CD4 < 350/mm3
      • HCV co-infection
    • No benefits of ATV/r monotherapy on lipids or renal function
  • NRTIs re-intensification was effective in all the individuals
  • The study was terminated early due to recommendation of IDMC
  • W96 results
  • HIV RNA < 50 c/mL
    • ATV/r monotherapy = 64% vs ATV/r + 2 NRTI = 63%
    • Difference (95% CI): 1.3% (-17.5 to 20.1%) => monotherapy not non inferior
  • ATV/r monotherapy arm
    • Median HIV RNA at viral rebound (N=14): 136 (72–376) copies/mL;
    • No PI- or NRTI-associated resistance mutations were observed and all patients re-suppressed after reintensification
  • Drug-related adverse events leading to discontinuation: 3 (6%) in ATV/r monotherapy arm vs 11 (21.5%) in the triple-therapy arm (p = 0.041)
  • The 96 week adjusted mean percentage change in total proximal femur BMD was +1.16% and -1.64% in the ATV/r monotherapy arm and the triple-therapy arm, respectively (p = 0.012)

Design :


* Randomisation was stratified on HIV RNA (≤ or > 100,000 c/mL) prior to ART start

Objective

  • Primary Endpoint : proportion with treatment success at W48
    • Treatment failure : treatment discontinuation for any cause or confirmed virologic rebound (first of 2 consecutive HIV RNA > 50 c/mL within 2 weeks)
    • Non -inferiority of ATV/ r (ITT analysis ) ; lower limit of the 2-sided 95 % CI for the difference = -10% ; sample size = 342 (171 x 2), 80% power
    • Interim analysis by IDMC in June 2013 : recommendation to stop further enrolment

Baseline characteristics and disposition

Efficacy results

Safety, N (%)

 

   

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