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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/3TCMONARK • 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. MONARK Study: LPV/r BID monotherapy vs LPV/r BID + ZDV/3TC Design MONARK Randomisation Open-label W96 N = 84 LPV/r 400/100 mg BID Adults > 18 years ARV-naïve HIV RNA < 100,000 c/mL CD4 cell count > 100/mm3 N = 54 LPV/r 400/100 mg BID + ZDV/3TC BID LPV/r soft-gel capsule was used • Objective • Primary endpoint: HIV RNA < 400 c/mL at W24 and < 50 c/mL at W48 • No power calculation due to limited sample size, and pilot nature of the study Delfraissy JF. AIDS 2008;22:385-93

  3. MONARK Study: LPV/r BID monotherapy vs LPV/r BID + ZDV/3TC MONARK Baseline characteristics and patient disposition Delfraissy JF. AIDS 2008;22:385-93

  4. MONARK Study: LPV/r BID monotherapy vs LPV/r BID + ZDV/3TC MONARK Efficacy (HIV RNA) at weeks 24 and 48 Primary endpoint : < 400 c/mL at W24 and < 50 c/mL at W48 < 400 c/mL at W24 < 50 c/mL at W48 < 400 c/mL at W24 and < 50 c/mL at W48 % p = 0.02 LPV/r (N = 83) LPV/r + ZDV/3TC (N = 53) 98 100 80 77 78 80 75 75 67 64 60 40 66 41 0 On treatment analysis ITT, missing and intensification = failure Median CD4 increase at W48: 151/mm3 (LPV/r monotherapy) vs 159/mm3 (LPV/r + ZDV/3TC) (p = 0.65) Delfraissy JF. AIDS 2008;22:385-93

  5. Resistance, safety and tolerability 24/136 patients qualified for resistance testing (rebound of HIV RNA > 500 c/mL): 21/83 in the LPV/r monotherapy group and 3/53 in the LPV/r + ZDV/3TC group PI-associated resistance mutations emerged in 3/21 patients on LPV/r monotherapy (L76V, M46I) Serious adverse event: 12% LPV/r mono vs 8% LPV/r + ZDV/3TC Similar frequency of clinical adverse events (mainly diarrhoea) and laboratory abnormalities (transaminases elevations) of at least moderate severity in the 2 groups Conclusion In antiretroviral-naïve patients, LPV/r monotherapy demonstrates lower rates of virologic suppression as compared with LPV/r + ZDV/3TC LPV/r monotherapy should not be offered for first-line antiretroviral therapy MONARK Study: LPV/r BID monotherapy vs LPV/r BID + ZDV/3TC MONARK Delfraissy JF. AIDS 2008;22:385-93