Switch studies in virologically suppressed patients

Switch to MVC
MARCH Study
Original article : Pett SL. Clin Infect Dis 2016;63:122-32
Dernière mise à jour : 06/09/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • This large international randomised study demonstrates that MVC with a 2-N(t)RTI backbone, in those with R5-tropic virus determined by genotypic tropism testing, is a switch/simplification option for patients virologicaly suppressed on PI/r + N(t)RTI regimens
  • MVC was safe and well tolerated, with favorable impact on lipids and neutral effects on renal function over 48 weeks
  • These data support MVC as a switch option for ritonavir-boosted PIs when partnered with a 2-N(t)RTI backbone, but not as part of N(t)RTI-sparing regimens comprising MVC with PI/r

Design

Objective

  • Primary Endpoint: proportion with HIV RNA < 200 copies/mL at W48
    • Non inferiority of the switch arms vs control, by intention-to-treat, lower margin of the two-sided 95% CI for the difference = - 12 %, 80 % power

Baseline characteristics and disposition

Virologic Outcomes – W48


* ≠ : - 4% ; (95% CI = - 9.0 to 2.2)
** ≠ : - 13.5% ; (95% CI = - 19.8 to -5.8)

% with virologic response (HIV RNA < 200 c/mL), by week

Emergent resistance in participants with confirmed virologic failure

Changes in immunologic and metabolic parameters and quality of life over 48 weeks


p : vs 2 NRTI + PI/r

Safety at W48

  • One myocardial infarction was reported on MVC in a patient with increased CVD risk due to lifestyle and cardiac congenital malformation

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