Purpose: We aim to confirm in an observational setting the long-term effectiveness of switching to BIC/FTC/TAF in older persons with HIV (PWH) who were already virologically suppressed. Method: Observational study in PWH enrolled in the ICONA cohort who started BIC/FTC/TAF as switching regimen while virologically suppressed from Jun-2016 to Aug-2023. Data were stratified according to be <65 or =65 years old. The primary endpoint was time to treatment failure (TF): discontinuation for toxicity/intolerance (TDT) or virological failure (VF, 2 HIV-RNA>200 copies/ml or 1>1000 copies/ml followed by ART change). Secondary endpoints were: i) VF; ii) TDT. Cumulative probabilities of endpoints were calculated by Kaplan-Meier curves till 192-weeks. Association of age strata with TF and TDT endpoints were investigated by Cox regression models adjusted for mode of HIV transmission, Italy-born, years on ART. Results: 1653 ART-experienced PWH switched to BIC/FTC/TAF: 1516 (91.7%) <65 years and 137 (8.3%) =65 years. Baseline characteristics shown in Figure1. Over a median follow-up of 216 weeks (IQR 156, 244), 76 (4.6%) out of 1653 switching PWH experienced TF (6 among =65y); 11 experienced VF (0 among =65y) and 65 experienced TDT (6 among =65y). The 192-week probabilities of TF, VF and TDT were 5.3% (95% 4.2-6.7), 1.0% (95% 0.5-1.8), and 4.4% (3.4%-5.7%), respectively. Kaplan-Meier curves according to age strata shown in Figure2. Reasons for TDT in PWH<65 and =65 years shown in Table1. Also in the adjusted analysis, we found no evidence for a different risk of TF or TDT in PWH aged =65 years compared to younger PWH. In detail, TF: aHR =65y vs <65y=1.02, 95%CI 0.43-2.38; TDT: aHR =65y vs <65y=1.13, 95%CI 0.48-2.65. Conclusions: Switching to BIC/FTC/TAF was well tolerated and virologically effective through a median follow-up of over four years, both in PWH 65< and =65 years of age.
Long-term effectiveness of bictegravir-emtricitabine-tenofovir alafenamide (BIC/FTC/TAF) as switch strategy in virologically suppressed people with HIV across age strata: observational data from the ICONA-BIC study / D'Arminio Monforte, A; Tavelli, A; Gagliardini, R; Rusconi, S; Taramasso, L; Cervo, A; Marocco, R; Mazzotta, V; Costantini, A; Burastero, G; Giacomelli, A; Saracino, A; Nozza, S; Lo Caputo, S; Antinori, A. - In: HIV MEDICINE. - ISSN 1468-1293. - STAMPA. - 26 (Suppl. 4):(2025), pp. eP091.314-eP091.315.
Long-term effectiveness of bictegravir-emtricitabine-tenofovir alafenamide (BIC/FTC/TAF) as switch strategy in virologically suppressed people with HIV across age strata: observational data from the ICONA-BIC study
Costantini A;
2025-01-01
Abstract
Purpose: We aim to confirm in an observational setting the long-term effectiveness of switching to BIC/FTC/TAF in older persons with HIV (PWH) who were already virologically suppressed. Method: Observational study in PWH enrolled in the ICONA cohort who started BIC/FTC/TAF as switching regimen while virologically suppressed from Jun-2016 to Aug-2023. Data were stratified according to be <65 or =65 years old. The primary endpoint was time to treatment failure (TF): discontinuation for toxicity/intolerance (TDT) or virological failure (VF, 2 HIV-RNA>200 copies/ml or 1>1000 copies/ml followed by ART change). Secondary endpoints were: i) VF; ii) TDT. Cumulative probabilities of endpoints were calculated by Kaplan-Meier curves till 192-weeks. Association of age strata with TF and TDT endpoints were investigated by Cox regression models adjusted for mode of HIV transmission, Italy-born, years on ART. Results: 1653 ART-experienced PWH switched to BIC/FTC/TAF: 1516 (91.7%) <65 years and 137 (8.3%) =65 years. Baseline characteristics shown in Figure1. Over a median follow-up of 216 weeks (IQR 156, 244), 76 (4.6%) out of 1653 switching PWH experienced TF (6 among =65y); 11 experienced VF (0 among =65y) and 65 experienced TDT (6 among =65y). The 192-week probabilities of TF, VF and TDT were 5.3% (95% 4.2-6.7), 1.0% (95% 0.5-1.8), and 4.4% (3.4%-5.7%), respectively. Kaplan-Meier curves according to age strata shown in Figure2. Reasons for TDT in PWH<65 and =65 years shown in Table1. Also in the adjusted analysis, we found no evidence for a different risk of TF or TDT in PWH aged =65 years compared to younger PWH. In detail, TF: aHR =65y vs <65y=1.02, 95%CI 0.43-2.38; TDT: aHR =65y vs <65y=1.13, 95%CI 0.48-2.65. Conclusions: Switching to BIC/FTC/TAF was well tolerated and virologically effective through a median follow-up of over four years, both in PWH 65< and =65 years of age.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
