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European Focus 29. 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(Adnkronos Salute) - Sono positivi i dati diffusi oggi da ViiV Healthcare - azienda globale specializzata nell'Hiv a maggioranza GlaxoSmithKline plc (Gsk), in partecipazione con Pfizer e Shionogi - e relativi a 48 settimane dello studio Paso Doble (Gesida studio 11720), il più ampio trial clinico randomizzato, testa a testa, di fase IV, che ha valutato il regime a 2 farmaci dolutegravir/lamivudina (Dtg/3Tc) rispetto al regime a 3 farmaci bictegravir/emtricitabina/tenofovir alafenamide fumarato (Bic/Ftc/Taf) per il trattamento dell'Hiv-1 in persone virologicamente soppresse che potrebbero trarre beneficio dall'ottimizzazione terapeutica. I risultati - si legge in una nota - hanno mostrato che lo switch a Dtg/3Tc, in adulti con Hiv virologicamente soppressi, ha dimostrato efficacia non inferiore nel mantenimento della soppressione virologica rispetto allo switch a Bic/Ftc/Taf. Questi dati saranno presentati alla 25esima Conferenza internazionale sull'Aids (Aids 2024), che si tiene a Monaco di Baviera, in Germania (22-26 luglio). "I risultati di Paso Doble - afferma Harmony P. Garges, Chief Medical Officer di ViiV Healthcare - mostrano che Dtg/3Tc ha dimostrato un'efficacia non inferiore rispetto a Bic/Ftc/Taf e che l'aumento di peso medio per i partecipanti allo studio che hanno assunto Dtg/3Tc è stato significativamente inferiore rispetto a quelli che hanno assunto Bic/Ftc/Taf nel corso dell'anno. Questo è un risultato significativo, poiché l'aumento di peso correlato al trattamento è un importante argomento per molte persone che vivono con l'Hiv. In ViiV Healthcare ci impegniamo ad offrire alle persone che vivono con l'Hiv trattamenti innovativi contro l'Hiv che non solo siano sicuri ed efficaci, ma che rispondano anche alle loro esigenze specifiche oltre la soppressione virologica".Nello studio clinico Paso Doble, 553 persone con Hiv virologicamente soppresse hanno cambiato il trattamento passando o a Dtg/3Tc (277) o a Bic/Ftc/Taf (276). La popolazione dello studio includeva individui che assumevano una terapia che poteva essere ottimizzata, come regimi a compresse multiple, regimi contenenti potenziatori farmacocinetici o farmaci associati a tossicità cumulativa, come efavirenz o tenofovir disoproxil fumarato. Lo studio ha raggiunto il suo endpoint primario quando Dtg/3Tc ha dimostrato un'efficacia non inferiore rispetto a Bic/Ftc/Taf in base alla percentuale di partecipanti con Rna virale maggiore o uguale a 50 copie/millilitro a 48 settimane secondo l'analisi snapshot Fda e un margine di non inferiorità del 4% nella popolazione intention-to-treat exposed. A 48 settimane, Dtg/3Tc era non inferiore a Bic/Ftc/Taf (differenza di rischio tra Dtg/3Tc [2,2%] meno Bic/Ftc/Taf [0,7%] dell'1,4%, Ic 95% da -0,5 a 3,4). Un partecipante nel braccio Bic/Ftc/Taf e zero nel braccio Dtg/3Tc hanno avuto un fallimento virologico confermato, definito dal protocollo, fino alla settimana 48 (Hiv-1 Rna ≥50 c/mL seguito da una seconda valutazione consecutiva di Hiv-1 Rna ≥200 c/mL). In un endpoint secondario chiave - prosegue la nota - lo studio ha rilevato che il peso è aumentato significativamente di più nei partecipanti che sono passati a Bic/Ftc/Taf (variazione media aggiustata 1,81 kg, Ic 95% 1,28-2,34) rispetto a quelli che sono passati a Dtg/3Tc (variazione media aggiustata 0,89 kg, Ic 95% 0,37-1,41) [differenza 0,92 kg, Ic 95% 0,17-1,66] fino alla settimana 48. Allo stesso modo, la percentuale di partecipanti con aumento di peso superiore al 5% alla settimana 48 era significativamente più alta, al 29,9%, per Bic/Ftc/Taf, rispetto al 20% per Dtg/3Tc (Or aggiustato 1,81, Ic 95% 1,19-2,76). La variazione di peso con Dtg/3Tc non differiva tra uomini e donne o in base al precedente regime dei partecipanti, mentre la percentuale di partecipanti allo studio che hanno riscontrato un aumento di peso superiore al 5% con Bic/Ftc/Taf era superiore di circa il 45% rispetto a quelli che assumevano Dtg/3Tc quando il regime precendente conteneva abacavir (30,6% Bic/Ftc/Taf vs 21,1% Dtg/3Tc) e circa 2 volte superiore quando il regime precedente conteneva Tdf (40,7% Bic/Ftc/Taf vs 19,5% Dtg/3Tc). La sicurezza è stata paragonabile fino alla settimana 48 e coerente con i profili di sicurezza noti. Ci sono state poche interruzioni dovute a eventi avversi in entrambi i bracci dello studio (Dtg/3Tc=1, 0,4%; Bic/Ftc/Taf=2, 0,7%), senza differenze tra i bracci."I regimi di trattamento dell'Hiv comunemente prescritti oggi - osserva Esteban Martínez, Chief Executive Investigator dello studio Paso Doble e Senior Consultant in Malattie infettive all'Hospital Clínic di Barcelona - sono tutti altamente efficaci, il che rende fondamentale studiare l'impatto di queste terapie oltre la semplice soppressione virologica. I risultati di Paso Doble mostrano che Dtg/3Tc, un regime a 2 farmaci, non solo ha dimostrato la stessa efficacia di un regime a 3 farmaci, ma ha anche mostrato un aumento di peso inferiore rispetto a Bic/Ftc/Taf nelle 48 settimane". di Adnkronos   24-07-2024 - 16:47 Link copiato Commenti Leggi la Netiquette

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