Immune Reconstitution and Safe Metabolic Profile after the Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate among Virologically Controlled PLWH: A 96 Week Update from the BICTEL Cohort
Alessandro Lazzaro,
Diana Bianchini,
Elio Gentilini Cacciola,
Ivano Mezzaroma,
Mario Falciano,
Carolina Andreoni,
Caterina Fimiani,
Letizia Santinelli,
Luca Maddaloni,
Ginevra Bugani,
Giancarlo Ceccarelli,
Claudio Maria Mastroianni,
Gabriella d’Ettorre
Affiliations
Alessandro Lazzaro
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Diana Bianchini
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Elio Gentilini Cacciola
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Ivano Mezzaroma
Department of Translational and Precision Medicine, Sapienza University of Rome, AOU Policlinico Umberto I of Rome, 00185 Rome, Italy
Mario Falciano
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Carolina Andreoni
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Caterina Fimiani
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Letizia Santinelli
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Luca Maddaloni
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Ginevra Bugani
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Giancarlo Ceccarelli
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Claudio Maria Mastroianni
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Gabriella d’Ettorre
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
Background: Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) is a recommended once-daily single-tablet regimen for the treatment of people living with HIV (PLWH). We aimed to assess efficacy, safety, and tolerability of BIC/FTC/TAF among PLWH, with a specific focus on people older than 55 years. Methods: We recruited an observational retrospective real-life cohort, including all PLWH who underwent a therapeutic switch to BIC/FTC/TAF, independently from the previous treatment regimen (the BICTEL cohort). Longitudinal nonparametric analyses and linear models were built. Results: After 96 weeks of follow-up, 164 PLWH were included, with 106 older than 55. Both the intention-to-treat and the per-protocol analysis showed low rates of virologic failure, independent of the pre-switch anchor drug. At week 96, a significant increase in CD4+ T cell count and in CD4+/CD8+ ratio was observed, inversely correlated with baseline immune status. Fasting serum lipid profile, total body weight, BMI, and hepatic function were not affected by the switch, without new onset of metabolic syndrome or weight gain. Compared to baseline, we observed a renal function worsening which is worthy of further follow-up. Conclusion: BIC/FTC/TAF is an effective, safe, and well-tolerated switching strategy for PLWH, especially among those older than 55.
