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Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE

Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE. ASSURE Study: switch ATV/r + TDF/FTC to ATV + ABC/3TC. Design. Randomisation 2 : 1 Open-label. W48. N = 199. 296 patients On TDF/FTC + ATV/r* HIV RNA < 75 c/mL > 6 months eCrCL > 50 mL/min. N = 97.

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Switch to ATV-containing regimen - ARIES - INDUMA - ASSURE

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  1. Switch to ATV-containing regimen • - ARIES • - INDUMA • - ASSURE

  2. ASSURE Study: switch ATV/r + TDF/FTC to ATV + ABC/3TC • Design Randomisation 2 : 1 Open-label W48 N = 199 296 patients On TDF/FTC + ATV/r* HIV RNA < 75 c/mL > 6 months eCrCL > 50 mL/min N = 97 * Prior first or second regimen switch allowed for any reason except virologic failure • Primary endpoint • Non inferiority in the proportion of patients with HIV RNA < 50 c/mL at W24 (TLOVR algorithm), lower limit of the 95% CI for the difference = - 12% Wohl D, ICAAC 2012, Abs H556c ASSURE

  3. ASSURE Study: switch ATV/r + TDF/FTC to ATV + ABC/3TC Baseline characteristics and patient disposition Wohl D, ICAAC 2012, Abs H556c ASSURE

  4. ASSURE Study: switch ATV/r + TDF/FTC to ATV + ABC/3TC Outcome at week 24 ATV + ABC/3TC ATV/r + TDF/FTC Other endpoints at W24 HIV RNA < 50 c/mL Virologic failure % 100 87 87 80 60 * Adjusteddifference (95% CI) : - 3.74% (-11.8%, 4.35%) ; ** p = 0.013 40 Resistance analysis in subjects with 2 consecutive RNA > 400 c/mL 20 3 1 0 Per protocol (TLOVR) N = 6 N = 1 95% CI for the difference= - 7.97 ; 8.64 Wohl D, ICAAC 2012, Abs H556c ASSURE

  5. ASSURE Study: switch ATV/r + TDF/FTC to ATV + ABC/3TC Outcome at week 48 ATV + ABC/3TC ATV/r + TDF/FTC Other endpoints at W48 HIV RNA < 50 c/mL % 96.3 100 91.1 79.4 76.4 80 * p = 0.026 60 40 • Confirmedvirologicfailure • ATV + ABC/3TC : 2% • ATV/r + TDF/FTC : 1% 20 0 Per protocol (TLOVR) Observed Wohl D, ICAAC 2013, Abs H665 ASSURE

  6. ASSURE Study: switch ATV/r + TDF/FTC to ATV + ABC/3TC • Safety • Similar nature and rate of Grade 2-4 clinical adverse events • Grade 2-4 adverse event leading to study withdrawal • ATV + ABC/3TC, n = 8 (rash = 2, nausea = 3, vomiting = 2) ; • ATV/r + TDF/FTC, n = 2 • Grade 3-4 laboratory abnormalities • ATV + ABC/3TC : 19% (hyperbilirubinemia 6%) • ATV/r + TDF/FTC : 36% (hyperbilirubinemia 29%) [p < 0.001 vs ATV + ABC/3TC] • Significant improvements observed in bone biomarkers (BAP, PTH, C­telopeptide, and osteocalcin), renal urine b2 microglobulin/ creatinine ratio in the ATV + ABC/3TC group Wohl D, ICAAC 2012, Abs H556c ; ICAAC 2013, Abs. H665 ASSURE

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