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
Download the slides
