Long-term outcomes of switching to BIC/FTC/TAF with or without prior INSTI experience: real-life data from a monocentric cohort of ART- experienced people with HIV

Objective: Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is currently one of the most valuable switch options for antiretroviral therapy (ART)-experienced people with HIV (PWH). Nevertheless, studies on long-term impact of prior experience of integrase strand transfer inhibitors (INSTIs) on such switch option are currently lacking. Methods: This observational retrospective real-life study presents a longitudinal analysis of data from a monocentric cohort of PWH who underwent a therapeutic switch to BIC/FTC/TAF from any other previous regimens. Results: Overall, 441 PWH were included in the study: 318 INSTI-experienced and 123 INSTI-naïve, of which 65 switching from non-nucleoside reverse transcriptase inhibitors (NNRTI)-based regimens and 58 from protease inhibitors (PI)-based regimens. At the end of 12 months follow-up, the overall population presented significant improvements in immunological and lipidic parameters, especially benefitting PWH switching from boosted INSTI-based regimes and INSTI-naïve PWH switching from PI-based regimens. Hepatic profiles were stable and a minor, not clinically relevant decrement of eGFR was reported. Virological efficacy of BIC/FTC/TAF switch could be inferred by observing PWH with detectable viral loads at the moment of switch (73, 16.6%): only five of them subsequently discontinued the regimen due to virologic failure or persistently detectable low viraemia. After a median duration of follow-up of 181 ± 66 weeks (3.48 ± 1.27 years), a quarter of the overall population discontinued BIC/FTC/TAF, with a median time of discontinuation of 213 weeks (4.38 years), with no differences according to prior INSTI experience. Conclusions: Our real-life data further support the role of BIC/FTC/TAF as a durable, safe and “lipid-friendly” ART switch option, also for PWH without prior INSTI experience.