Ulteriori analisi degli studi RESIST di fase III indicano che Tipranavir/rtv (500/200 mg, BID) è superiore a LPV/rtv (IP di comparazione) se combinato con altri farmaci attivi, in pazienti pre-trattati.Seguono ulteriore analisi in merito a TPV/rtv, nuovo inibitore della Boehringer Ingelheim che a breve dovrebbe vedere “il sì” delle autorità regolatorie. I ricercatori hanno messo a confronto, in questa analisi, il nuovo inibitore con LPV/rtv e la presenza di altri farmaci attivi, compreso il T-20.
Di seguito riportiamo i risultati dell’analisi, che conclude che TPV/r è superiore nella risposta a LPV/r (ed in tutti i casi di confronto, soprattutto in presenza di più farmaci attivi); inoltre è simile anche la sicurezza tra le due molecole.
1483 patients were randomized and treated in the 2 trials; 1159 were available for analysis at 24 weeks. Median baseline values: VL, 4.8 log10 copies/mL; CD4+ cell count, 162 cells/mm3; number of protease gene mutations, 16. Patients had previously received a median 12 prior ARVs.
At 24 weeks, treatment response (ITT-NCF) was seen in 39.6% (116/293) and 21.4% (62/290) in the TPV/r and LPV/r groups, respectively (P<0.05); 34% and 18% respectively had VLs <400 copies/mL; 24% and 11% respectively had <50 copies/mL; and CD4+ increase was +31 cells/mm3 and +6 cells/mm3, respectively.
The 24-week treatment response increased in both the TPV/r and CPI/r groups with the use of more active background ARVs: 0 active background ARVs used (13.1% vs 9.1%, respectively), 1 (37.4% vs 12.9%), 2 (46.2% vs 19.9%), or ≥3 (54.7% vs 34.3%). A total of 24.7% of patients used T20.
At week 24, the treatment response in patients using T20 was: TPV/r arm, 58.2%; CPI/r arm, 25.8%. The treatment response in patients not using T20 was: TPV/r arm, 34.9%; CPI/r arm, 16.9%.
D Cooper, C Hicks and others. 24-Week RESIST Study Analyses: The Efficacy of Tipranavir/Ritonavir (TPV/r) is superior to lopinavir/ritonavir (LPV/r) and the TPV/r treatment response is enhanced by inclusion of genotypically active antiretrovirals in the optimized background regimen (OBR). Abstract 560 (poster). 12th Conference on Retrovirals and Opportunistic Infections. February 22-25, 2005. Boston, MA.
J Schapiro, P Cahn and others. Impact of baseline genotype on response to tipranavir/ritonavir (TPV/r) compared with standard-of-care comparator PI (CPI/r) in treatment-experienced patients: results from the phase 3 RESIST-1 and RESIST-2 trials. 12th Conference on Retrovirals and Opportunistic Infections. February 22-25, 2005. Boston, MA.