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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. ATV vs ATV/r BMS 089 LPV/r mono vs LPV/r + ZDV/3TC MONARK LPV/r QD vs BID M02-418 M05-730A5073 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 Comparison of PI vs PI

  2. Study M05-730: LPV/r QD vs BID, in combination with TDF + FTC QD M05-730 • Design Randomisation 1:1:1:1 Open-label W8 W48 W96 LPV/r tablet BID + TDF + FTC N = 166 LPV/r tablet BID + TDF + FTC N = 331 N = 165 LPV/r SGC BID + TDF + FTC 664 patients> 18 years ARV-naïve HIV RNA > 1,000 c/mL LPV/r tablet QD + TDF + FTC N = 167 LPV/r tablet QD + TDF + FTC N = 333 N = 166 LPV/r SGC QD + TDF + FTC • Objective • Primary endpoint: HIV RNA < 50 c/mL at W48 (ITT, NC = F) • Non-inferiority of LPV/r QD vs BID if lower margin of the 95% CI for the difference = - 12% (> 90% power) LPV/r dose: 400/100 mg BID or 800/200 mg QD Gathe J. JAIDS 2009;50:474-81

  3. Study M05-730: LPV/r QD vs BID, in combination with TDF + FTC QD M05-730 Patient disposition and baseline characteristics Gathe J. JAIDS 2009;50:474-81

  4. Study M05-730: LPV/r QD vs BID, in combination with TDF + FTC QD M05-730 Response to treatment at week 48 • Mean CD4 increase at W48: 186/mm3 (QD) vs 198/mm3 (BID) (p = 0.32) • Sensitivity ITT, NC = F, analysis adjusting for baseline imbalance in HIV RNA level confirms non inferiority of virologic response (95% CI for the difference = - 6; 7) • Sub-group post hoc analyses: • % HIV RNA < 50 c/mL similar at W48 with QD and BID LPV/r, according to subgroups defined by baseline HIV RNA (< or > 100,000 c/mL) or CD4 count (< 50, 50 to < 200 or > 200/mm3) • for patients with baseline HIV RNA> 100,000 c/mL and CD4 < 200/mm3,HIV RNA < 50 c/ml = 74% QD vs 73 % BID QD (N = 333) BID (N = 331) Primaryefficacyendpoint % 100 90 87 77 76 80 60 40 20 0 ITT, NC = F Observed data 95% CI for the difference = - 5; 8 95% CI for the difference = - 8; 3 Gathe J. JAIDS 2009;50:474-81

  5. Study M05-730: LPV/r QD vs BID, in combination with TDF + FTC QD M05-730 Adverse events and resistance • During the first 8 weeks of treatment • Clinical (gastrointestinal) and laboratory (lipids) tolerability similar for SGC and tablets • Resistance • Among 17 subjects (10 QD and 7 BID) tested for resistance (HIV RNA > 50 c/mL at or after W24 and confirmed > 400 c/mL within 4 weeks): no emergence of PI or TDF resistance mutations. M184V emergence in 3 patients (2 QD, 1 BID) Gathe J. JAIDS 2009;50:474-81

  6. Study M05-730: LPV/r QD vs BID, in combination with TDF + FTC QD M05-730 • Summary - Conclusion • In antiretroviral-naïve adults, LPV/r QD was virologically non inferior at W48to LPV/r BID, when administered in combination with TDF and FTC • During the first 48 weeks of therapy, there were no significant differencesin the safety or tolerability of QD vs BID LPV/r • This study used LPV/r tablets, and did not show differences in rate of diarrhoea between QD and BID dosing • In subgroups with high baseline HIV RNA and/or low CD4 count, efficacyof LPV/r QD and BID was similar • Absence of resistance emergence to LPV/r or TDF, in either groups • Limited and similar lipid impact of both LPV/r dosing • Patient preference of the tablet over the soft-gel capsule • Results support the use of LPV/r QD in combination with TDF and FTC in antiretroviral-naive patients Gathe J. JAIDS 2009;50:474-81