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Switch to ATV/r Monotherapy: Swedish Study (ATARITMO, ACTG A5201, OREY, MODAt Study)

This study focuses on the efficacy and safety of switching to ATV/r monotherapy in HIV patients who were stable on ATV/r and two NRTIs for at least 48 weeks. The primary endpoint was treatment success at week 48, with treatment failure defined as treatment discontinuation or confirmed virologic rebound. The study was terminated early due to recommendations from the IDMC.

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Switch to ATV/r Monotherapy: Swedish Study (ATARITMO, ACTG A5201, OREY, MODAt Study)

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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

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