Less Drugs for more Safety, Convenience and Sustainability: the Italian experiences Roma, Istituto Superiore Sanità marzo 2011 Conference Chairmen: Roberto Cauda, Giuliano Rizzardini Tavola rotonda: i nuovi paradigmi nellesperienza italiana Antonio Di Biagio, Genova
Inclusion Criteria for PROGRESS (M10-336) HIV-1 infection ARV-naïve Plasma HIV-1 RNA >1000 copies/mL Any CD4+ T-cell count LPV/r + RAL vs. LPV/r + TDF/FTC in Treatment- Naive Subjects: PROGRESS Study Design Primary endpoint: plasma HIV-1 RNA <40 copies/mL at week 48 (FDA ITT TLOVR) Non-inferiority assessed by 95% CI for the difference ([LPV/r + RAL] – [LPV/r + TDF/FTC]) using a -20% threshold If non-inferiority with respect to the -20% margin was demonstrated, then non-inferiority with respect to a - 12% margin was to be evaluated
Primary Efficacy Endpoint at Week 48: Proportion of Subjects Responding (FDA ITT TLOVR)
RAL+LPV/r: Esperienza personale 4 pazienti nella sperimentazione PROGRESS (M10-336) 5 pazienti off-label 1 paziente naive (pregresso aneurisma aorta, rene policistico, GFR ml/min) 4 cART experienced (mai PI booster) Nessuna resistenza a LPV/r
21/10/2008: prima visita ambulatoriale EO: riduzione del pannicolo adiposo –Peso 47 Kg Esami ematochimici: –GB 3530 (N 63,7%) –Hb 13,9; MCV ( 85,5) –PLT –Funzionalità epatica e renale nn –CD4+ 32/mmc (6,3%) –HIV RNA cp/ml –GRT: Wild Type
Buona compliance alla TARV No effetti collaterali TARV correlati Peso 57 KgPeso 47 Kg
Costi: stima A.O.U. San Martino, Genova In collaborazione Dr.ssa Marcella Bado, U.O. Farmacia