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Volume 15
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10.3390/v15061222
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Article

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

by
Alessandro Lazzaro
1,
Diana Bianchini
1,
Elio Gentilini Cacciola
1,
Ivano Mezzaroma
2,
Mario Falciano
1,
Carolina Andreoni
1,
Caterina Fimiani
1,
Letizia Santinelli
1,
Luca Maddaloni
1,
Ginevra Bugani
1,
Giancarlo Ceccarelli
1,
Claudio Maria Mastroianni
1 and
Gabriella d’Ettorre
1,*
1
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy
2
Department of Translational and Precision Medicine, Sapienza University of Rome, AOU Policlinico Umberto I of Rome, 00185 Rome, Italy
*
Author to whom correspondence should be addressed.
Viruses 2023, 15(6), 1222; https://doi.org/10.3390/v15061222
Submission received: 31 March 2023 / Revised: 11 May 2023 / Accepted: 14 May 2023 / Published: 23 May 2023
(This article belongs to the Special Issue Efficacy and Safety of Antiviral Therapy)
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Abstract

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.
Keywords: bictegravir; BIC/FTC/TAF; switch; HIV; antiretroviral; real-life; safety; efficacy; tolerability; immune reconstitution bictegravir; BIC/FTC/TAF; switch; HIV; antiretroviral; real-life; safety; efficacy; tolerability; immune reconstitution

Share and Cite

MDPI and ACS Style

Lazzaro, A.; Bianchini, D.; Gentilini Cacciola, E.; Mezzaroma, I.; Falciano, M.; Andreoni, C.; Fimiani, C.; Santinelli, L.; Maddaloni, L.; Bugani, G.; et al. 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. Viruses 2023, 15, 1222. https://doi.org/10.3390/v15061222

AMA Style

Lazzaro A, Bianchini D, Gentilini Cacciola E, Mezzaroma I, Falciano M, Andreoni C, Fimiani C, Santinelli L, Maddaloni L, Bugani G, et al. 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. Viruses. 2023; 15(6):1222. https://doi.org/10.3390/v15061222

Chicago/Turabian Style

Lazzaro, Alessandro, Diana Bianchini, Elio Gentilini Cacciola, Ivano Mezzaroma, Mario Falciano, Carolina Andreoni, Caterina Fimiani, Letizia Santinelli, Luca Maddaloni, Ginevra Bugani, and et al. 2023. "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" Viruses 15, no. 6: 1222. https://doi.org/10.3390/v15061222

APA Style

Lazzaro, A., Bianchini, D., Gentilini Cacciola, E., Mezzaroma, I., Falciano, M., Andreoni, C., Fimiani, C., Santinelli, L., Maddaloni, L., Bugani, G., Ceccarelli, G., Mastroianni, C. M., & d’Ettorre, G. (2023). 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. Viruses, 15(6), 1222. https://doi.org/10.3390/v15061222

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