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.
