Switch studies in virologically suppressed patients
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Switch to ATV/ r + 3TC
SALT Study
Original article : Perez-Molina JA. Lancet Infect Dis 2015; 15:775-84,
Perez-Molina JA, JAC 2077; 72:246-53
Last update : 03/01/2017

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Switching to ATV/r + 3TC is effective, safe, and non-inferior to ATV/r + 2 NRTI in virologically suppressed HIV+ patients, who need change any antiretroviral previous triple therapy because of toxicity, intolerance or simplification
    • Switching from a triple to a dual ATV-based regimen is not associated with an increased risk of virological failure, which was low in both groups, with most patients with virological failure with HIV RNA < 200 c/ml
    • Frequency of blips throughout the 48 weeks was equivalent in both groups
    • Only 1 patient (triple-treatment group) developed resistance mutation (M184V)
    • Few patients discontinued the study in the 2 groups because of toxic effects, with treatment interruptions being significantly more frequent in the triple-treatment group
    • No significant differences in change from baseline in neurocognitive function, neither renal function, bone mineral density, or fat gain or distribution between groups at week 96

Design


* Randomisation was stratified on active HCV infection and previous treatment (NNRTI, PI/r, CCR5 antagonist, integrase inhibitor)

Objective

  • Primary Endpoint : proportion with treatment success at W48
    • Treatment failure : treatment discontinuation or modification for any cause or confirmed virologic rebound (2 consecutive HIV RNA > 50 c/mL )
    • Non -inferiority of ATV/r + 3TC ( p er protocol) ; lower limit of the 95 % CI for the difference = -12%

Baseline characteristics and disposition at W48

Efficacy and Safety Results (W48)

Efficacy and Safety Results (W96)

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