Background We aim to confirm in a real-life setting the clinical trial data of the long-term effectiveness of B/F/TAF, both as first-line therapy and as a switch strategy, in virologically suppressed persons with HIV (PWH) up to 192-weeks. Materials and Methods Observational cohort study of PWH enrolled in ICONA who started B/F/TAF as initial therapy or as switching regimen while virologically suppressed from June 2016 to August 2023. The primary endpoint was time to treatment failure (TF): discontinuation for toxicity/intolerance or virological failure (VF, 2 HIV-RNA>200 copies/ml or 1 >1000 copies/ml followed by ART change, >6 months from starting for naive). Secondary endpoints: i) VF as previously defined and ii) discontinuation for toxicity/intolerance (TDT). Cumulative probabilities of the three endpoints were calculated by Kaplan- Meier curves at 144 weeks (and 192 weeks for ART experienced). Results 929 ART-naive and 1653 ART-experienced PWH initiated B/F/TAF. Baseline characteristics are shown in table 1. ART-naïve group: over a median follow-up of 141 weeks (IQR 94–189), 54 (5.8%) ART-naïve PWH experienced TF, 17 VF and 37 discontinuations for toxicity/intolerance. The cumulative probability of TF at 144 weeks was 6.7% (95%CI 5.0–8.8) [figure 1A]. The 144-week probability of VF was 2.7% (1.6–4.4): in detail, 9 of 17 VF did not reach VS after 6 months, while 8/17 had a viral rebound after the first suppression. The median HIV-RNA at VF were 2,287 and 958 copies/ml. Only 4 changed B/F/TAF after VF, 6 out of the 9 PWH with virological follow-up after VF reached HIVRNA< 50 while remaining on B/F/TAF. The 144-week probability of TDT was instead 4.3% (3–6.2). The reasons for TDT are shown in table 2A. ART-experienced virologically suppressed group Over a median follow-up of 216 weeks (IQR 156, 244), 76 (4.6%) out of 1653 switching PWH experienced TF (11 VF and 65 TDT); The cumulative probability of TF at 144- and 192-weeks were 4.0% (4.2–6.7) and 5.3% (4.2–6.7), respectively [figure 1B]. The probabilities of VF were 0.7% (0.4–1.4) at 144- and 1.0% (0.5–1.8) at 192 weeks. Median HIV-RNA values at VF were 3400 and 1539 copies/ml, respectively. Only 4 PWH changed B/F/TAF after VF, 6/6 PWH with virological followup after VF while remaining on B/F/TAF reached HIVRNA< 50 copies/ml. Finally, the 144-week and 192-week probability of TDT were 3.4% (2.6–4.4) and 4.4% (3.4%- 5.7%), respectively. The reasons for TDT are shown in table 2B. Conclusion Overall, we in the clinical real-life setting B/F/TAF is well tolerated and virologically effective in ART-naïve and experienced PWH in the long term up to 192-weeks. Discontinuation for toxicity remains a rare event both in naïve (4.3% at 144 weeks) and experienced (3.4% and 4.4% at 144 and 192 weeks). VF was low both in naïve and experienced PWH, given the subsequent VS without ART change, we can hypothesize that in those PWH, poor adherence was the cause of VF.
OC52 Long-term effectiveness of bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF) as first-line therapy and as switch strategy in virologically suppressed persons with HIV up to 192-weeks: 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; Null, Null. - In: SEXUALLY TRANSMITTED INFECTIONS. - ISSN 1368-4973. - STAMPA. - 101 (Suppl. 1):(2025), pp. OC52.49-OC52.50. [10.1136/sextrans-icar-2025.46]
OC52 Long-term effectiveness of bictegravir-emtricitabine-tenofovir alafenamide (B/F/TAF) as first-line therapy and as switch strategy in virologically suppressed persons with HIV up to 192-weeks: data from the ICONA-BIC Study
Costantini, A;
2025-01-01
Abstract
Background We aim to confirm in a real-life setting the clinical trial data of the long-term effectiveness of B/F/TAF, both as first-line therapy and as a switch strategy, in virologically suppressed persons with HIV (PWH) up to 192-weeks. Materials and Methods Observational cohort study of PWH enrolled in ICONA who started B/F/TAF as initial therapy or as switching regimen while virologically suppressed from June 2016 to August 2023. The primary endpoint was time to treatment failure (TF): discontinuation for toxicity/intolerance or virological failure (VF, 2 HIV-RNA>200 copies/ml or 1 >1000 copies/ml followed by ART change, >6 months from starting for naive). Secondary endpoints: i) VF as previously defined and ii) discontinuation for toxicity/intolerance (TDT). Cumulative probabilities of the three endpoints were calculated by Kaplan- Meier curves at 144 weeks (and 192 weeks for ART experienced). Results 929 ART-naive and 1653 ART-experienced PWH initiated B/F/TAF. Baseline characteristics are shown in table 1. ART-naïve group: over a median follow-up of 141 weeks (IQR 94–189), 54 (5.8%) ART-naïve PWH experienced TF, 17 VF and 37 discontinuations for toxicity/intolerance. The cumulative probability of TF at 144 weeks was 6.7% (95%CI 5.0–8.8) [figure 1A]. The 144-week probability of VF was 2.7% (1.6–4.4): in detail, 9 of 17 VF did not reach VS after 6 months, while 8/17 had a viral rebound after the first suppression. The median HIV-RNA at VF were 2,287 and 958 copies/ml. Only 4 changed B/F/TAF after VF, 6 out of the 9 PWH with virological follow-up after VF reached HIVRNA< 50 while remaining on B/F/TAF. The 144-week probability of TDT was instead 4.3% (3–6.2). The reasons for TDT are shown in table 2A. ART-experienced virologically suppressed group Over a median follow-up of 216 weeks (IQR 156, 244), 76 (4.6%) out of 1653 switching PWH experienced TF (11 VF and 65 TDT); The cumulative probability of TF at 144- and 192-weeks were 4.0% (4.2–6.7) and 5.3% (4.2–6.7), respectively [figure 1B]. The probabilities of VF were 0.7% (0.4–1.4) at 144- and 1.0% (0.5–1.8) at 192 weeks. Median HIV-RNA values at VF were 3400 and 1539 copies/ml, respectively. Only 4 PWH changed B/F/TAF after VF, 6/6 PWH with virological followup after VF while remaining on B/F/TAF reached HIVRNA< 50 copies/ml. Finally, the 144-week and 192-week probability of TDT were 3.4% (2.6–4.4) and 4.4% (3.4%- 5.7%), respectively. The reasons for TDT are shown in table 2B. Conclusion Overall, we in the clinical real-life setting B/F/TAF is well tolerated and virologically effective in ART-naïve and experienced PWH in the long term up to 192-weeks. Discontinuation for toxicity remains a rare event both in naïve (4.3% at 144 weeks) and experienced (3.4% and 4.4% at 144 and 192 weeks). VF was low both in naïve and experienced PWH, given the subsequent VS without ART change, we can hypothesize that in those PWH, poor adherence was the cause of VF.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.