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Comparison of PI vs PI

Comparison of PI vs PI. ATV vs ATV/r BMS 089 LPV/r mono vs LPV/r + ZDV/3TC MONARK LPV/r QD vs BID M02-418 M05-730 A5073 LPV/r + 3TC vs LPV/r + 2 NRTI GARDEL ATV/r vs FPV/r ALERT FPV/r vs LPV/r KLEAN SQV/r vs LPV/r GEMINI ATV/r vs LPV/r CASTLE DRV/r vs LPV/r ARTEMIS.

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Comparison of PI vs PI

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  1. Comparison of PI vs PI • ATV vs ATV/rBMS 089 • LPV/r mono vs LPV/r + ZDV/3TC MONARK • LPV/r QD vs BIDM02-418M05-730A5073 • LPV/r + 3TC vs LPV/r + 2 NRTI GARDEL • ATV/r vs FPV/r ALERT • FPV/r vs LPV/r KLEAN • SQV/r vs LPV/r GEMINI • ATV/r vs LPV/r CASTLE • DRV/r vs LPV/r ARTEMIS

  2. Study BMS 089: ATV vs ATV/r QD,in combination with 3TC + d4T XR QD BMS 089 • Design Randomisation* 1 : 1 Open-label W48 200 adults ARV-naïve or < 30 days of prior NRTI or < 7 days of prior NNRTI or PI HIV RNA > 2,000 c/mL Any CD4 cell count N = 95 N = 105 *Randomisation was stratified on HIV RNA < or > 100,000 c/mL • Objective • Non inferiority of ATV/r 300/100 vs ATV 400 at W48: • % HIV RNA < 400 c/mL, ITT, TLOVR algorithm (lower margin of the 95% CI for the difference = -10%, 80% power) Malan DR. JAIDS 2008;47:161-7

  3. Study BMS 089: ATV vs ATV/r QD,in combination with 3TC + d4T XR QD BMS 089 Baseline characteristics and patient disposition Malan DR. JAIDS 2008;47:161-7

  4. Study BMS 089: ATV vs ATV/r QD,in combination with 3TC + d4T XR QD BMS 089 Response to treatment at week 48 (ITT, TLOVR) ATV/r (N = 95) Primaryendpoint ATV (N = 105) % HIV RNA< 400 c/mL HIV RNA< 50 c/mL HIV RNA < 50 c/mL 100 87 86 85 82 80 75 70 63 58 60 40 20 N = 46 50 49 55 0 All patients Baseline HIV RNA < 100,000 c/mL Baseline HIV RNA > 100,000 c/mL 95% CI for the difference = - 8.2; 11.1 95% CI for the difference = - 7; 17 Median CD4 increase at W48: 174/mm3 (ATV/r) vs 213/mm3 (ATV) Malan DR. JAIDS 2008;47:161-7

  5. Study BMS 089: ATV vs ATV/r QD,in combination with 3TC + d4T XR QD BMS 089 Treatment-emergent resistance Genotypic and phenotypic resistance in patients with virologic failure through W48 # Same patient; * Among 20I/T, 33F, 34Q, 36V, 64V, 71V, 73S, 74A, 83D Malan DR. JAIDS 2008;47:161-7

  6. Study BMS 089: ATV vs ATV/r QD,in combination with 3TC + d4T XR QD BMS 089 Safety Upward shift of > 1 NCEP category at W48 for ATV/r vs ATV: • total cholesterol: 16% vs 11% • LDL-cholesterol: 46% vs 48% • triglycerides: 30% vs 18% Malan DR. JAIDS 2008;47:161-7

  7. Study BMS 089: ATV vs ATV/r QD,in combination with 3TC + d4T XR QD BMS 089 • Summary - Conclusion • For first-line antiretroviral therapy, ATV/r 300/100 mg QD was virologically non inferior to ATV 400 mg QD, when combined with 3TC and d4T XR QD • Response rate at an HIV RNA < 50 c/mL at W48 was 25% less in patientswith baseline HIV RNA > 100,000 c/mL as compared with baseline HIV RNA< 100,000 c/mL • Virologic failure occurred more frequently in the ATV group (9.5% vs 3.2%)with emergence of major atazanavir-associated mutations in 3/8 tested patients in the ATV group • Results (HIV RNA < 50 c/mL at W48, virologic failure rate, resistance data) suggest ATV/r is more potent than ATV • Discontinuation due to treatment-related adverse event occurred more frequently in the ATV/r group • Increases in total cholesterol and triglycerides were greater in the ATV/r group • Possible impact of stavudine on lipid increases • Limitation: small size of the study Malan DR. JAIDS 2008;47:161-7

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