AIDS, new data on the efficacy and safety of Gilead HIV therapy Glasgow 2022

New clinical results presented at the 30th International Congress on Drug Therapy in HIV Infection, Glasgow, highlight Bic / Ftc / Taf (bictegravir 50 mg / emtricitabine 200 mg / tenofoviralafenamide 25 mg tablets, B / F / Taf) as a generally well tolerated and effective in people with HIV, regardless of previous treatment and comorbid status. This was announced by Gilead who promoted the real world study BICSTaR, presented at the ‘Hiv Glasgow 2022’ meeting. The latest 5-year data from two phase III studies (Study 1489 and Study 1490) – reads a note – provide evidence on the long-term safety and efficacy profile of Bic / Ftc / Taf in subjects who switch from a regimen containing dolutegravir. New ‘real-world’ data from the 24-month follow-up analysis of BICSTaR were presented at the international conference, which assessed the efficacy and safety of Bic / Ftc / Taf in clinical practice in nine countries. . The analysis included follow-up performed during the Covid-19 pandemic and considered age, race, sex, adherence and late diagnosis in the population arm. Study participants who started treatment experienced high viral suppression (HIV-1 Rna <50 copie/ml). Complessivamente, il 97% (104/107) dei partecipanti naïve al trattamento e il 95% (497/521) dei partecipanti con esperienza di trattamento hanno ottenuto la soppressione virale a 24 mesi. Non ci sono state segnalazioni di resistenza emergente durante il trattamento. Le interruzioni del trattamento (14% in totale) sono state poche e una percentuale limitata di persone (7%) ha interrotto Bic/Ftc/Taf a causa di eventi avversi correlati al farmaco: i più segnalati sono stati variazioni di peso (3%) e depressione (1%). Ulteriori dati degli Studi 1489 e 1490 presentati alla conferenza di Glasgow dimostrano che Bic/Ftc/Taf ha un’elevata efficacia e una sicurezza prolungata nelle persone che effettuano lo switch al trattamento, con un’elevata barriera genetica. Questi risultati sono stati segnalati nei partecipanti 96 settimane in seguito allo switchin aperto a Bic/Ftc/Taf, dopo 144 settimane di dolutegravir in cieco + 2 NRTI. Alla settimana 240, oltre il 99% dei partecipanti sia allo Studio 1489 (217/218) sia allo Studio 1490 (232/234) ha ottenuto la soppressione virale. Inoltre, a ogni visita, per 240 settimane, lo studio ha dimostrato che, dopo lo switch a Bic/Ftc/Taf, l’efficacia era >96%, which proves that Bic / Ftc / Taf can provide sustained viral suppression to people with HIV even after a treatment change. Bic / Ftc / Taf was generally well tolerated, with 0.4% (2/519) of participants switching in both studies experiencing an adverse event that resulted in drug discontinuation during the open extension. There were no interruptions due to renal events. The most frequently reported adverse events during the open-label extension phase were diarrhea (0.6%) and weight change (0.6%).