1 / 6

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 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.

hume
Télécharger la présentation

Comparison of PI vs PI

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related