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Switch to ATV/r monotherapy

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Switch to ATV/r monotherapy

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  1. Switch to ATV/r monotherapy • ATARITMO • Swedish Study • ACTG A5201 • OREY • MODAtStudy

  2. MODAt Study: switch to ATV/r monotherapy • Design Randomisation* 1: 1 Open-label W48 W96 ATV/r 300/100 mg qd + 2 NRTI (continuation) ≥ 18 years Stable ATV/r + 2 NRTI ≥ 48 weeks with HIV RNA < 50 c/mL > 24 weeks No previous virologic failure CD4+ nadir > 100/mm3 No PPI or H2-receptor antagonists HBs Ag negative N = 51 ATV/r 300/100 mg monotherapy N = 52 * Randomisation was stratified on HIV RNA (≤ or > 100 000 c/mL) prior to ART start • Objective • Primary Endpoint: proportion with treatment success at W48 • Treatment failure: treatment discontinuation for any cause or confirmed virologic rebound (first of 2 consecutive HIV RNA > 50 c/mL within 2 weeks) • Non-inferiority of ATV/r (ITT analysis) ; lower limit of the 2-sided 95% CI for the difference = -10% ; sample size = 342 (171 x 2), 80% power • Interim analysis by IDMC in June 2013: recommendation to stop further enrolment Castagna A. AIDS 2014;28:2269-79 MODAt

  3. MODAt Study: switch to ATV/r monotherapy Baseline characteristics and disposition Castagna A. AIDS 2014;28:2269-79 MODAt

  4. MODAt Study: switch to ATV/r monotherapy Efficacy results HIV RNA < 50 c/mL at W48 (ITT) Confirmed virologic rebound ATV/r + 2 NRTI ATV/r Re-intensification = failure Re-intensification = success % 100 92 85 85 80 73 60 40 20 44/ 52 37/ 51 44/ 52 47/ 51 Predictor of treatment failure in the ATV/r arm : HCV co-infection (HR : 7.64 ; 95% CI: 1.44 to 40.47, p = 0.017) 0 ≠ (95% CI) -12.1 (- 27.8 ; 3.6) ≠ (95% CI) 7.5 (- 4.7 ; 19.8) Castagna A. AIDS 2014;28:2269-79 MODAt

  5. MODAt Study: switch to ATV/r monotherapy Safety, N (%) Castagna A. AIDS 2014;28:2269-79 MODAt

  6. MODAt Study: switch to ATV/r monotherapy • Conclusion • ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy with ATV/r + 2 NRTI • Inferiority more pronounced in those with • Pre-ART HIV RNA > 100 000 c/mL • Nadir CD4 < 350/mm3 • HCV co-infection • No benefits of ATV/r monotherapy on lipids or renal function • NRTIs re-intensification was effective in all the individuals • The study was terminated early due to recommendation of IDMC Castagna A. AIDS 2014;28:2269-79 MODAt

  7. MODAt Study: switch to ATV/r monotherapy • W96 results • HIV RNA < 50 c/mL • ATV/r monotherapy = 64% vs ATV/r + 2 NRTI = 63% • Difference (95% CI): 1.3% (-17.5 to 20.1%) monotherapy not non inferior • ATV/r monotherapy arm • Median HIV RNA at viral rebound (N=14): 136 (72–376) copies/mL; • No PI- or NRTI-associated resistance mutations were observed and all patients re-suppressed after reintensification • Drug-related adverse events leading to discontinuation: 3 (6%) in ATV/r monotherapy arm vs 11 (21.5%) in the triple-therapy arm (p = 0.041) • The 96 week adjusted mean percentage change in total proximal femur BMD was +1.16% and -1.64% in the ATV/r monotherapy arm and the triple-therapy arm, respectively (p = 0.012) Galli L. JAIDS 2016;71:1637-42 MODAt