Comparing the efficacy and safety of a first line regimen with emtricitabine/tenofovir alafenamide fumarate plus either bictegravir or dolutegravir: Results from clinical practice.

Bictegravir HIV dolutegravir first-line naive

Journal

International journal of antimicrobial agents
ISSN: 1872-7913
Titre abrégé: Int J Antimicrob Agents
Pays: Netherlands
ID NLM: 9111860

Informations de publication

Date de publication:
17 Nov 2023
Historique:
received: 13 02 2023
revised: 29 10 2023
accepted: 14 11 2023
medline: 20 11 2023
pubmed: 20 11 2023
entrez: 19 11 2023
Statut: aheadofprint

Résumé

In the last decade, first-line Integrase strand transfer inhibitors (INSTI) based regimens have become commonly used in clinical practice. We aimed to analyze and compare the efficacy and safety of bictegravir (BIC) and dolutegravir (DTG) when prescribed in association with emtricitabine/tenofovir alafenamide (FTC/TAF) as part of a first-line regimen for the treatment of HIV-1 infection. We analyzed a cohort of treatment naïve PLWHIV starting a first line regimen with either BIC/FTC/TAF (BIC group) or FTC/TAF+DTG (DTG group). We performed snapshot analyses after 24 and 48 weeks evaluating virological efficacy. We also evaluated differences in the rate of treatment discontinuation (TD) between the two groups, via the Kaplan Meier method and the Log Rank test. We analyzed data from 327 PLWHIV: 140 in the DTG group and 187 in the BIC group. At 48 weeks, 90.0% of individuals in the DTG group and 86.7% of those in the BIC group achieved a HIV-RNA<50 copies/mL. We observed 88 TD in the DTG group and 38 in the BIC group; estimated probabilities of maintaining study regimen at week 48 were 59.5% in the DTG group and 84.2% in the BIC group. Analyzing changes in immunological parameters after 48 weeks, we registered a median improvement of +169 cell/mm3 (p<0.001) in the DTG group and +233 cell/mm3 (p<0.001) in the BIC group. Both BIC and DTG, in combination with FTC/TAF, show promising efficacy and safety as first-line strategies in clinical practice, with a favorable immunological recovery even in the short term.

Sections du résumé

BACKGROUND BACKGROUND
In the last decade, first-line Integrase strand transfer inhibitors (INSTI) based regimens have become commonly used in clinical practice. We aimed to analyze and compare the efficacy and safety of bictegravir (BIC) and dolutegravir (DTG) when prescribed in association with emtricitabine/tenofovir alafenamide (FTC/TAF) as part of a first-line regimen for the treatment of HIV-1 infection.
METHODS METHODS
We analyzed a cohort of treatment naïve PLWHIV starting a first line regimen with either BIC/FTC/TAF (BIC group) or FTC/TAF+DTG (DTG group). We performed snapshot analyses after 24 and 48 weeks evaluating virological efficacy. We also evaluated differences in the rate of treatment discontinuation (TD) between the two groups, via the Kaplan Meier method and the Log Rank test.
RESULTS RESULTS
We analyzed data from 327 PLWHIV: 140 in the DTG group and 187 in the BIC group. At 48 weeks, 90.0% of individuals in the DTG group and 86.7% of those in the BIC group achieved a HIV-RNA<50 copies/mL. We observed 88 TD in the DTG group and 38 in the BIC group; estimated probabilities of maintaining study regimen at week 48 were 59.5% in the DTG group and 84.2% in the BIC group. Analyzing changes in immunological parameters after 48 weeks, we registered a median improvement of +169 cell/mm3 (p<0.001) in the DTG group and +233 cell/mm3 (p<0.001) in the BIC group.
CONCLUSIONS CONCLUSIONS
Both BIC and DTG, in combination with FTC/TAF, show promising efficacy and safety as first-line strategies in clinical practice, with a favorable immunological recovery even in the short term.

Identifiants

pubmed: 37981074
pii: S0924-8579(23)00329-1
doi: 10.1016/j.ijantimicag.2023.107040
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

107040

Informations de copyright

Copyright © 2023. Published by Elsevier Ltd.

Auteurs

Arturo Ciccullo (A)

Infectious Diseases Unit, San Salvatore Hospital, L'Aquila, Italy. Electronic address: arturo.ciccullo@gmail.com.

Gianmaria Baldin (G)

Unit of Infectious Diseases, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Mater Olbia Hospital, Olbia, Italy.

Vanni Borghi (V)

Azienda Ospedaliero Universitaria di Modena, Clinica Malattie Infettive e Tropicali, Modena, Italy.

Letizia Oreni (L)

UOC Malattie Infettive III, DIBIC Luigi Sacco, University of Milan, Milan, Italy.

Filippo Lagi (F)

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

Paolo Fusco (P)

Infectious and Tropical Disease Unit, Department of Medical and Surgical Sciences, "Magna Graecia" University of Catanzaro, Catanzaro, Italy.

Andrea Giacomelli (A)

UOC Malattie Infettive III, DIBIC Luigi Sacco, University of Milan, Milan, Italy.

Carlo Torti (C)

Infectious and Tropical Disease Unit, Department of Medical and Surgical Sciences, "Magna Graecia" University of Catanzaro, Catanzaro, Italy.

Gaetana Sterrantino (G)

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

Cristina Mussini (C)

Azienda Ospedaliero Universitaria di Modena, Clinica Malattie Infettive e Tropicali, Modena, Italy.

Spinello Antinori (S)

UOC Malattie Infettive III, DIBIC Luigi Sacco, University of Milan, Milan, Italy.

Simona DI Giambenedetto (SD)

Unit of Infectious Diseases, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Catholic University of the Sacred Heart, Rome, Italy.

Classifications MeSH