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1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results.

BACKGROUND: Switching strategy with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) has become a gold standard for people with HIV (PLWHIV) with high efficacy and safety rates in long-term data of pivotal clinical trials. However, data regarding immune status restoration in real-life c...

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Autores principales: Estévez, Samuel, Buzón, Luis, Pousada, Guillermo, Tomé, Roberto Pedrero, Galera, Carlos, Sanz, Jose, Santos, Ignacio, Dueñas, Carlos, Cabello, Noemí, Martín, Cristina, Galindo, María José, Garcinuño, María Ángeles, Hernández, Cristina, Lebón, Gabriela, Fernández, Beatriz, Troya, Jesús
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678094/
http://dx.doi.org/10.1093/ofid/ofad500.1406
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author Estévez, Samuel
Buzón, Luis
Pousada, Guillermo
Tomé, Roberto Pedrero
Galera, Carlos
Sanz, Jose
Santos, Ignacio
Dueñas, Carlos
Cabello, Noemí
Martín, Cristina
Galindo, María José
Garcinuño, María Ángeles
Hernández, Cristina
Lebón, Gabriela
Fernández, Beatriz
Troya, Jesús
author_facet Estévez, Samuel
Buzón, Luis
Pousada, Guillermo
Tomé, Roberto Pedrero
Galera, Carlos
Sanz, Jose
Santos, Ignacio
Dueñas, Carlos
Cabello, Noemí
Martín, Cristina
Galindo, María José
Garcinuño, María Ángeles
Hernández, Cristina
Lebón, Gabriela
Fernández, Beatriz
Troya, Jesús
author_sort Estévez, Samuel
collection PubMed
description BACKGROUND: Switching strategy with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) has become a gold standard for people with HIV (PLWHIV) with high efficacy and safety rates in long-term data of pivotal clinical trials. However, data regarding immune status restoration in real-life cohorts of long-time treated patients are needed. METHODS: We performed a multicenter, retrospective study of suppressed PLWHIV switching to BIC/FTC/TAF. We evaluated the efficacy and immune status regarding CD4+ and CD8+ T-cell counts and CD4/CD8 ratio at 48 and 96 weeks after the switch. RESULTS: The study population comprised 1315 persons from 11 centers in Spain, of whom 78.5% were men, and the median age was 51 [42.0 – 57.0] years. The median time of HIV infection was 17 [10.0 – 27.0] years, and patients with AIDS diagnosis represented 23.6%. The main reasons for switching to BIC/FTC/TAF were simplification (57.5%), poor tolerability (11.5%), and drug-to-drug interactions (7.3%). Patients reached weeks 48 and 96 in 98.7% and 83.2% of cases, respectively, with only 16 (1.2%) virological failures but no resistance mutations. Other reasons for discontinuation comprised toxicity issues 3.3.% (44), loss to follow-up 2,8% (37), and simplification 5.0% (66). The baseline median CD4 was 718.0 [494.0 – 946.8]. In week 48, we found a decrease in CD8+ T-cell count of -37.5 cells/mm(3) (-244.3 – 135.3) and an increase in CD4+ T-cell count of 39.0 (-104.3 – 165.3) compared to baseline. In week 96, we found a decrease in CD8+ T-cell count of -25.0 cells/mm(3) (-245.3 – 178.5) and an increase in CD4+ T-cell count of 40.5 (-157.0 – 230.0) compared to baseline. The CD4/CD8 ratio increased by 0.05 (-0.09 – 0.29) and 0.08 (-0.12 – 0.31) in weeks 48 and 96, respectively. In the subgroup of AIDS-diagnosed patients, a significant increase in the CD4+ T-cell count of 39.0 cells/mm(3)(-77.0 – 149.0), p=0.025, was found at week 48, and a decrease in the CD8+ T-cell count of -5.0 (-202.0 – 181.5) cells/mm(3); p=0.050, at week 96. CONCLUSION: In patients with HIV-controlled infection, switching to triple therapy with BIC/FTC/TAF slightly improved the immune status during the first 48-96 weeks after switching, not only in terms of CD4+ T-cell count increase and CD8+ decrease but also in CD4/CD8 ratio with high rates of viral control and safety. DISCLOSURES: Luis Buzón, MD, PhD, Janssen: Advisor/Consultant|Janssen: Expert Testimony|MSD: Expert Testimony|Viiv: Advisor/Consultant|Viiv: Expert Testimony Carlos Galera, MD, Gilead: Expert Testimony|Jannsen: Expert Testimony|MSD: Expert Testimony|VIIV: Expert Testimony Jose Sanz, MD, PhD, Gilead: Expert Testimony|Janssen: Expert Testimony|MSD: Expert Testimony|ViiV: Expert Testimony Ignacio Santos, MD. PhD, Gilead: Expert Testimony Carlos Dueñas, MD, Gilead: Advisor/Consultant|Gilead: Expert Testimony|Jannsen: Advisor/Consultant|Jannsen: Expert Testimony Noemí Cabello, MD. PhD, Gilead: Expert Testimony|Janssen: Expert Testimony|ViiV: Expert Testimony Cristina Martín, MD, Gilead: Expert Testimony|Janssen: Expert Testimony|Pfizer: Expert Testimony María José Galindo, MD, PhD, Gilead: Expert Testimony|janssen: Expert Testimony Cristina Hernández, MD, Gilead: Expert Testimony|MSD: Expert Testimony|Viiv: Expert Testimony Jesús Troya, Staff, Gilead: Advisor/Consultant|Gilead: Expert Testimony|Janssen: Board Member|Janssen: Grant/Research Support|ViiV: Advisor/Consultant
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spelling pubmed-106780942023-11-27 1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results. Estévez, Samuel Buzón, Luis Pousada, Guillermo Tomé, Roberto Pedrero Galera, Carlos Sanz, Jose Santos, Ignacio Dueñas, Carlos Cabello, Noemí Martín, Cristina Galindo, María José Garcinuño, María Ángeles Hernández, Cristina Lebón, Gabriela Fernández, Beatriz Troya, Jesús Open Forum Infect Dis Abstract BACKGROUND: Switching strategy with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) has become a gold standard for people with HIV (PLWHIV) with high efficacy and safety rates in long-term data of pivotal clinical trials. However, data regarding immune status restoration in real-life cohorts of long-time treated patients are needed. METHODS: We performed a multicenter, retrospective study of suppressed PLWHIV switching to BIC/FTC/TAF. We evaluated the efficacy and immune status regarding CD4+ and CD8+ T-cell counts and CD4/CD8 ratio at 48 and 96 weeks after the switch. RESULTS: The study population comprised 1315 persons from 11 centers in Spain, of whom 78.5% were men, and the median age was 51 [42.0 – 57.0] years. The median time of HIV infection was 17 [10.0 – 27.0] years, and patients with AIDS diagnosis represented 23.6%. The main reasons for switching to BIC/FTC/TAF were simplification (57.5%), poor tolerability (11.5%), and drug-to-drug interactions (7.3%). Patients reached weeks 48 and 96 in 98.7% and 83.2% of cases, respectively, with only 16 (1.2%) virological failures but no resistance mutations. Other reasons for discontinuation comprised toxicity issues 3.3.% (44), loss to follow-up 2,8% (37), and simplification 5.0% (66). The baseline median CD4 was 718.0 [494.0 – 946.8]. In week 48, we found a decrease in CD8+ T-cell count of -37.5 cells/mm(3) (-244.3 – 135.3) and an increase in CD4+ T-cell count of 39.0 (-104.3 – 165.3) compared to baseline. In week 96, we found a decrease in CD8+ T-cell count of -25.0 cells/mm(3) (-245.3 – 178.5) and an increase in CD4+ T-cell count of 40.5 (-157.0 – 230.0) compared to baseline. The CD4/CD8 ratio increased by 0.05 (-0.09 – 0.29) and 0.08 (-0.12 – 0.31) in weeks 48 and 96, respectively. In the subgroup of AIDS-diagnosed patients, a significant increase in the CD4+ T-cell count of 39.0 cells/mm(3)(-77.0 – 149.0), p=0.025, was found at week 48, and a decrease in the CD8+ T-cell count of -5.0 (-202.0 – 181.5) cells/mm(3); p=0.050, at week 96. CONCLUSION: In patients with HIV-controlled infection, switching to triple therapy with BIC/FTC/TAF slightly improved the immune status during the first 48-96 weeks after switching, not only in terms of CD4+ T-cell count increase and CD8+ decrease but also in CD4/CD8 ratio with high rates of viral control and safety. DISCLOSURES: Luis Buzón, MD, PhD, Janssen: Advisor/Consultant|Janssen: Expert Testimony|MSD: Expert Testimony|Viiv: Advisor/Consultant|Viiv: Expert Testimony Carlos Galera, MD, Gilead: Expert Testimony|Jannsen: Expert Testimony|MSD: Expert Testimony|VIIV: Expert Testimony Jose Sanz, MD, PhD, Gilead: Expert Testimony|Janssen: Expert Testimony|MSD: Expert Testimony|ViiV: Expert Testimony Ignacio Santos, MD. PhD, Gilead: Expert Testimony Carlos Dueñas, MD, Gilead: Advisor/Consultant|Gilead: Expert Testimony|Jannsen: Advisor/Consultant|Jannsen: Expert Testimony Noemí Cabello, MD. PhD, Gilead: Expert Testimony|Janssen: Expert Testimony|ViiV: Expert Testimony Cristina Martín, MD, Gilead: Expert Testimony|Janssen: Expert Testimony|Pfizer: Expert Testimony María José Galindo, MD, PhD, Gilead: Expert Testimony|janssen: Expert Testimony Cristina Hernández, MD, Gilead: Expert Testimony|MSD: Expert Testimony|Viiv: Expert Testimony Jesús Troya, Staff, Gilead: Advisor/Consultant|Gilead: Expert Testimony|Janssen: Board Member|Janssen: Grant/Research Support|ViiV: Advisor/Consultant Oxford University Press 2023-11-27 /pmc/articles/PMC10678094/ http://dx.doi.org/10.1093/ofid/ofad500.1406 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstract
Estévez, Samuel
Buzón, Luis
Pousada, Guillermo
Tomé, Roberto Pedrero
Galera, Carlos
Sanz, Jose
Santos, Ignacio
Dueñas, Carlos
Cabello, Noemí
Martín, Cristina
Galindo, María José
Garcinuño, María Ángeles
Hernández, Cristina
Lebón, Gabriela
Fernández, Beatriz
Troya, Jesús
1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results.
title 1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results.
title_full 1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results.
title_fullStr 1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results.
title_full_unstemmed 1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results.
title_short 1571. BIC/FTC/TAF in Virologically Suppressed PLWHIV: 48-96 weeks RETROBIC Multicenter Cohort study results.
title_sort 1571. bic/ftc/taf in virologically suppressed plwhiv: 48-96 weeks retrobic multicenter cohort study results.
topic Abstract
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678094/
http://dx.doi.org/10.1093/ofid/ofad500.1406
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