Effectiveness, safety and discontinuation rates of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in people with HIV using real-world data: a systematic review and meta-analysis.


Journal

The Journal of antimicrobial chemotherapy
ISSN: 1460-2091
Titre abrégé: J Antimicrob Chemother
Pays: England
ID NLM: 7513617

Informations de publication

Date de publication:
17 May 2024
Historique:
received: 27 12 2023
accepted: 23 04 2024
medline: 17 5 2024
pubmed: 17 5 2024
entrez: 17 5 2024
Statut: aheadofprint

Résumé

The use of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is based on the results of robust clinical trials. To assess the effectiveness and safety of BIC/FTC/TAF in treatment-naïve (TN) and treatment-experienced (TE) people with HIV using available real-world cohort studies. Systematic review and meta-analysis of publications and communications identified via Boolean search in Medline, PubMed and Embase, and conference abstracts reporting retrospective real-world use of BIC/FTC/TAF, published until 31 January 2024. The primary endpoint was the proportion of TN and TE people with HIV with viral load (VL) < 50 copies/mL at 48 weeks while on treatment. Of the 38 identified publications and conference abstracts, for the present analysis we included 12 publications (comprising 792 TN and 6732 TE individuals). For the three publications including 507 TN participants reporting the primary outcome, VL suppression was 97% [95% confidence intervals (CI): 89-100]. For the nine publications including 4946 TE participants reporting the primary outcome, VL suppression was 95% (95% CI: 94-96), with suppression >93% in all studies. Total discontinuations at 48 weeks in TE individuals were 3% (95% CI: 2-5), 1% (95% CI: 0-2) due to side effects. A total of four publications with 151 TE individuals with previous presence of M184V substitution were identified, reporting a suppression rate at 48 weeks of 95% (95% CI: 88-100). Real-world studies demonstrate low discontinuation rates and high rates of virologic suppression in individuals treated with BIC/FTC/TAF, both TN and TE with and without previous detection of M184V substitution.

Sections du résumé

BACKGROUND BACKGROUND
The use of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is based on the results of robust clinical trials.
OBJECTIVES OBJECTIVE
To assess the effectiveness and safety of BIC/FTC/TAF in treatment-naïve (TN) and treatment-experienced (TE) people with HIV using available real-world cohort studies.
METHODS METHODS
Systematic review and meta-analysis of publications and communications identified via Boolean search in Medline, PubMed and Embase, and conference abstracts reporting retrospective real-world use of BIC/FTC/TAF, published until 31 January 2024. The primary endpoint was the proportion of TN and TE people with HIV with viral load (VL) < 50 copies/mL at 48 weeks while on treatment.
RESULTS RESULTS
Of the 38 identified publications and conference abstracts, for the present analysis we included 12 publications (comprising 792 TN and 6732 TE individuals). For the three publications including 507 TN participants reporting the primary outcome, VL suppression was 97% [95% confidence intervals (CI): 89-100]. For the nine publications including 4946 TE participants reporting the primary outcome, VL suppression was 95% (95% CI: 94-96), with suppression >93% in all studies. Total discontinuations at 48 weeks in TE individuals were 3% (95% CI: 2-5), 1% (95% CI: 0-2) due to side effects. A total of four publications with 151 TE individuals with previous presence of M184V substitution were identified, reporting a suppression rate at 48 weeks of 95% (95% CI: 88-100).
CONCLUSIONS CONCLUSIONS
Real-world studies demonstrate low discontinuation rates and high rates of virologic suppression in individuals treated with BIC/FTC/TAF, both TN and TE with and without previous detection of M184V substitution.

Identifiants

pubmed: 38758191
pii: 7675998
doi: 10.1093/jac/dkae138
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Gilead Sciences

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

Auteurs

Iván Chivite (I)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

Leire Berrocal (L)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

Elisa de Lazzari (E)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.

Soodabeh Navadeh (S)

Gilead Sciences, Inc, Foster City, USA.

Carla Lluis-Ganella (C)

Gilead Sciences SL, Madrid, Spain.

Alexy Inciarte (A)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

Lorena de la Mora (L)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

Ana González-Cordón (A)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

Maria Martínez-Rebollar (M)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

Montserrat Laguno (M)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.

Berta Torres (B)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.

José Luis Blanco (JL)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.

Esteban Martínez (E)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.

Josep Mallolas (J)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.

Juan Ambrosioni (J)

HIV Unit, Infectious Disease Service, Hospital Clinic- Fundacio de Recerca Clinic Barcelona-Institut d'nvestigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.

Classifications MeSH