Head-to-head comparative trials for first line ART since 2006

NRTI-Sparing
MODERN Study: MVC QD + DRV/r vs TDF/FTC + DRV/r
Original article : Stellbrink HJ. AIDS 2016; 30:1229-38
Last update : 25/05/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • MVC 150 mg QD + DRV/r QD was statistically inferior to TDF/FTC
    + DRV/r QD in antiretroviral-naïve subjects over 48 weeks
  • Lower rate of virologic suppression
  • IDMC recommended study termination
  • The majority of failure had HIV RNA < 400 c/ mL
  • There was no treatment-emergent resistance in either arm
  • Safety was comparable
  • MVC 150 mg QD in dual therapy with DRV/r QD cannot be recommended as first-line antiretroviral therapy

Design :

Objective :

  • Non inferiority of MVC at W48: % HIV RNA < 50 c/mL by intention to treat, missing, switch, discontinuation = failure, snapshot analysis (lower margin of the 95% CI for the difference = -10%)

Baseline characteristics and patient disposition


Study was terminated early upon recommendation of IDMC

Response to treatment at week 48

Mean CD4+ cell count//mm 3 changes at W48 : MVC = + 195 vs TDF/FTC = + 194

Protocol-defined treatment failure (PDTF) criteria

  • Decrease in plasma HIV RNA < 1 log10 from baseline after W4, unless plasma HIV RNA is < 50 c/mL, or
  • Plasma HIV RNA > 1 log10 c/mL above the nadir value after W4, or
  • Plasma HIV RNA ≥ 50 c/mL at any time after W24, or
  • Plasma HIV RNA ≥ 50 c/mL after suppression to < 50 c/mL on 2 consecutive visits, or
  • Decrease in plasma HIV RNA < 2 log10 c/mL from baseline on or after W12, unless plasma HIV RNA is < 50 c/mL (amendment 2), and < 400 c/mL (amendment 3)
  • All PDTFs required confirmation within 28 days of the initial event


* 3 in each group had HIV RNA < 400 c/ mL and showed a response at W48

Treatment-emergent adverse events at week 48

   

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