Download
comparison of pi vs pi n.
Skip this Video
Loading SlideShow in 5 Seconds..
Comparison of PI vs PI PowerPoint Presentation
Download Presentation
Comparison of PI vs PI

Comparison of PI vs PI

139 Vues Download Presentation
Télécharger la présentation

Comparison of PI vs PI

- - - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

  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