Purpose: Our aim was to investigate the durability of bictegravir/emtricitabine/tenofovir alafenamide (B/F/ TAF) regimen and its safety in a real-life setting. Method: Consecutive people with HIV (PWH) enrolled in SCOLTA project switching to or initiating their first antiretroviral treatment (ART) with B/F/TAF were included. PWH were followed up until treatment discontinuation and grade 3-4 adverse events (AE) were recorded. Hazard ratio (HR and 95% confidence interval, CI) for discontinuation were calculated using the Cox proportional hazard model. Results: Of 1164 enrolled PWH, 961 had at least one follow-up visit and entered the analysis (See Table 1). Mean age was 48.2 y (±12.6), 75.4% were male, mean BMI was 25.3 Kg/m2 (±4.5), 27.0% were naïve (N) to antiretrovirals at T0. The median CD4+ count was 532 cells/ mm3 (interquartile range (IQR) 320-785). After a median of 24 months of observation (IQR 13-36), 179 (18.6%) discontinued the treatment. The main reason was the switch to a new treatment reported in 67 PWH (25 to long-acting ART, 13 to dual treatment, 29 unspecified). Thirty-five people interrupted due to AE (12 neuropsychiatric), 6 died (4 cancers, 1 sepsis and 1 unknown), and five had a treatment failure (3 ART-naïve, 2 ARTexperienced). The median time at discontinuation was 17 months (IQR 8-27). In a multivariate model, older age was protective (aHR 0.98, 95% CI 0.97-0.99 by 1 year) and being naïve represented a risk factor for discontinuation (aHR 1.54, 95% CI 1.08-2.19). CD4+ level >350 cells/ mm3 decreased the likelihood of interruption (aHR 0.73, 95% CI 0.52-1.02, p=0.06). People starting the regimen in 2021-2022 were more likely to discontinue than those who started in 2019-2020 (aHR 1.65 95% CI 1.19- 2.29). Conclusions: B/F/TAF shows durability and tolerability in real-life use. The main reason for discontinuation is switching to a different regimen for reasons other than treatment failure or AE occurrence.
Safety and durability of treatment with bictegravir/emtricitabine/tenofovir alafenamide in a real-life cohort / Squillace, Nicola; Ricci, Elena; Maggi, Paolo; Taramasso, Lucia; Menzaghi, Barbara; Sarchi, E.; Vittorio De Socio, Giuseppe; Piconi, Stefania; Francesco Pellicanò, Giovanni; Bini, Teresa; Madeddu, Giordano; Martini, Salvatore; Pontali, Emanuele; Cenderello, Giovanni; Bandera, Alessandra; Maurizio Celesia, Benedetto; Orofino, Giancarlo; Ferrara, Sergio; Antonietta Carleo, Maria; Cascio, Antonio; Di Biagio, Antonio; Bonfanti., Paolo. - In: HIV MEDICINE. - ISSN 1468-1293. - (2025), pp. 408-409. [10.1111/hiv.70104]
Safety and durability of treatment with bictegravir/emtricitabine/tenofovir alafenamide in a real-life cohort.
Giordano Madeddu;
2025-01-01
Abstract
Purpose: Our aim was to investigate the durability of bictegravir/emtricitabine/tenofovir alafenamide (B/F/ TAF) regimen and its safety in a real-life setting. Method: Consecutive people with HIV (PWH) enrolled in SCOLTA project switching to or initiating their first antiretroviral treatment (ART) with B/F/TAF were included. PWH were followed up until treatment discontinuation and grade 3-4 adverse events (AE) were recorded. Hazard ratio (HR and 95% confidence interval, CI) for discontinuation were calculated using the Cox proportional hazard model. Results: Of 1164 enrolled PWH, 961 had at least one follow-up visit and entered the analysis (See Table 1). Mean age was 48.2 y (±12.6), 75.4% were male, mean BMI was 25.3 Kg/m2 (±4.5), 27.0% were naïve (N) to antiretrovirals at T0. The median CD4+ count was 532 cells/ mm3 (interquartile range (IQR) 320-785). After a median of 24 months of observation (IQR 13-36), 179 (18.6%) discontinued the treatment. The main reason was the switch to a new treatment reported in 67 PWH (25 to long-acting ART, 13 to dual treatment, 29 unspecified). Thirty-five people interrupted due to AE (12 neuropsychiatric), 6 died (4 cancers, 1 sepsis and 1 unknown), and five had a treatment failure (3 ART-naïve, 2 ARTexperienced). The median time at discontinuation was 17 months (IQR 8-27). In a multivariate model, older age was protective (aHR 0.98, 95% CI 0.97-0.99 by 1 year) and being naïve represented a risk factor for discontinuation (aHR 1.54, 95% CI 1.08-2.19). CD4+ level >350 cells/ mm3 decreased the likelihood of interruption (aHR 0.73, 95% CI 0.52-1.02, p=0.06). People starting the regimen in 2021-2022 were more likely to discontinue than those who started in 2019-2020 (aHR 1.65 95% CI 1.19- 2.29). Conclusions: B/F/TAF shows durability and tolerability in real-life use. The main reason for discontinuation is switching to a different regimen for reasons other than treatment failure or AE occurrence.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
