Switch studies in virologically suppressed patients

Switch to ATV/r + RAL
HARNESS Study
Original article : Van Lunzen J. JAIDS 2016;71:538-43 & Van Lunzen J. IAC 2014, Melbourne, Abs. LBPE19
Dernière mise à jour : 17/03/2016

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • In virologically suppressed patients on a triple-drug antiretroviral regimen, switching to ATV/r + RAL resulted in a lower maintenance of virologic suppression and a higher incidence of virologic rebound than in the ATV/r + TDF/FTC group at Week 24 and Week 48
  • In addition, tolerability issues and treatment discontinuation occurred more frequently and adherence was lower with ATV/r + RAL
  • This pilot study did not support switching to ATV/r + RAL for safety/tolerability reasons in treatment-experienced patients with virological suppression

Design

Objective

  • Primary Endpoint: proportion with treatment success at W24 (HIV-1 RNA < 40 c/mL)
    • No power calculation
    • Descriptive analysis

Baseline characteristics and disposition

Efficacy and Safety results

HIV RNA < 40 c/mL (ITT)

Confirmed virologic rebound at W48, N


* 1 patient with both PI and INSTI mutations

Virologic rebound

  • 2 consecutive on-treatment HIV RNA > 40 c/mL
  • Last on-treatment HIV RNA > 40 c/mL followed by discontinuation

Time to treatment failure (discontinuation of study therapy before W48
or virologic rebound before or at W48) - Kaplan-Meier estimate

Safety at W48, N

  • ATV and RAL geometric mean Ctrough values, available for most patients, were within therapeutic ranges over the study course
   

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