Risultati a 24 settimane, su pazienti fortemente pre-trattati, molto buoni del TMC 114/rtv (600/100 mg), bis in die, nuovo IP della Tibotec. Nessun effetto collaterale particolare segnalato.
“Efficacy of TMC114/r in 3-Class-Experienced Patients with Limitred Treatment Options: 24 week planned interim analysis of two 96-week multi-national studies”
–study patients had extensive treatment-experience; used average of 11 prior ARVs, 4 PIs, 1 NNRTI, 5 NRTIs. 15% previously used T20. Patients had extensive resistance to PIs: LPV/r 80-fold; ATV 38-fold; SQV 29-fold; APV 19-fold; TMC114 4-fold; patients had 18 protease mutations.
–Efficacy of TMC114 was greatest with 600 mg b.i.d. and significantly better than control
–Sustained mean VL reduction 1.85 vs. 0.27 log for control group
–Patients with >1 log reduction 72% vs. 16% for control group
–Patients with <50 copies/mL 47% vs. 9% for control group
–Mean CD4 cells/mm3 increase 75 vs. 15 for control group
–patients who used T20 (naive) : 67% in 600mg bid group had <50 copies/ml (ITT NC=F); patients with 3 or more primary PI mutations: 48% had <50 copies/ml; patients with no sensitive ARV in OBR: 31% had <50 copies/ml
–TMC114 safety and tolerability was comparable to available boosted PI regimens and not dose dependent
–TMC114/RTV 600/100 mg b.i.d. shows promise for 3-class-experienced patients with limited treatment options and has been selected for Phase 3 studies