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Comparison of PI vs PI

Comparison of PI vs PI

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Comparison of PI vs PI

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  1. Comparison of PI vs PI • ATV vs ATV/r BMS 089 • LPV/r mono vs LPV/r + ZDV/3TC MONARK • LPV/r QD vs BIDM02-418M05-730A5073 • ATV/r vs FPV/r ALERT • FPV/r vs LPV/r KLEAN • SQV/r vs LPV/rGEMINI • ATV/r vs LPV/r CASTLE • DRV/r vs LPV/r ARTEMIS

  2. GEMINI Study: SQV/r BID vs LPV/r BID,in combination with TDF/FTC GEMINI • Design Randomisation* 1 : 1 Open-label W48 > 18 years ARV-naïve or < 2 weeks of prior ARV exposure HIV RNA > 10,000 c/mL CD4 < 350/mm3 No active HBV infection N = 167 N = 170 SQV was administered as 500 mg tablet; LPV/r as soft-gel capsule, changed to tablet when it became available • Objective • Non inferiority of SQV/r vs LPV/r at W48: % HIV RNA < 50 c/mL,ITT-Exposed, Missing = Failure (lower margin of the 1-sided 98% [equivalent to 2-sided 96%] CI for the difference = - 12%) Walmsley S. JAIDS 2009;50:367-74

  3. GEMINI Study: SQV/r BID vs LPV/r BID,in combination with TDF/FTC GEMINI Baseline characteristics and patient disposition Walmsley S. JAIDS 2009;50:367-74

  4. GEMINI Study: SQV/r BID vs LPV/r BID,in combination with TDF/FTC GEMINI Response to treatment at week 48 % HIV RNA < 50 c/mL Median CD4 (/mm3) increase 100 Primary efficacy endpoint 204 SQV/r 200 178 80 LPV/r 65.5 64.7 63.5 62.1 160 60 120 40 80 20 40 N = 167 170 148 145 0 ITT-E,M = F Per protocol 0 96% CI for the difference= - 9.6; 11.9 96% CI for the difference= - 8.1; 15.0 p = 0.33 Virologic failures (2 consecutive HIV RNA > 400 c/mL at W16 or after): 11 (7%) (SQV/r) vs 5 (3%) (LPV/r) Emergence of M184V: 5/11 SQV/r vs 4/5 LPV/r; emergence of major PI mutations: 1 SQV/r vs 0 LPV/r ITT-E, M = F: ITT-exposed, missing = failure Walmsley S. JAIDS 2009;50:367-74

  5. GEMINI Study: SQV/r BID vs LPV/r BID,in combination with TDF/FTC Safety and tolerability: SQV/r vs LPV/r Low frequency of premature discontinuations for adverse events:3% vs 7% Most frequent reported adverse events of any grade were gastrointestinal disorders: 17% vs 27% No discontinuation because of renal-related adverse events; 2 patients, in the LPV/r arm, had elevated plasma creatinine levels > 2 mg/dL attributed to TDF/FTC Median changes at W48 in total, LDL- and HDL-cholesterol were not significantly different between treatment groups; elevation of triglycerides was significantly higher in the LPV/r arm GEMINI Walmsley S. JAIDS 2009;50:367-74

  6. GEMINI Study: SQV/r BID vs LPV/r BID,in combination with TDF/FTC Conclusions SQV/r BID was non inferior to LPV/r BID, in combination withTDF/FTC fdc Virologic and immunologic responses were similar in both arms Tolerability was similar in both arms Gastrointestinal adverse events were more frequent with LPV/r Lipid changes were not different between SQV/r and LPV/r except for triglycerides elevation, which was higher with LPV/r Rate of virologic failure was low in both groups 1 patient in the SQV/r group developed new major protease resistance mutations at virologic failure GEMINI Walmsley S. JAIDS 2009;50:367-74