1. Rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy in HIV infection. A prospective study.
- Author
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Ugarte A, De La Mora L, De Lazzari E, Chivite I, Fernández E, Inciarte A, Laguno M, Ambrosioni J, Solbes E, Berrocal L, González-Cordón A, Martínez-Rebollar M, Foncillas A, Calvo J, Blanco JL, Martínez E, Mallolas J, and Torres B
- Subjects
- Humans, Male, Adult, Prospective Studies, Female, Heterocyclic Compounds, 4 or More Rings administration & dosage, Heterocyclic Compounds, 4 or More Rings therapeutic use, Heterocyclic Compounds, 4 or More Rings adverse effects, Piperazines administration & dosage, Amides administration & dosage, Amides therapeutic use, Adenine analogs & derivatives, Adenine therapeutic use, Adenine administration & dosage, Adenine adverse effects, Drug Combinations, Heterocyclic Compounds, 3-Ring administration & dosage, Heterocyclic Compounds, 3-Ring therapeutic use, Heterocyclic Compounds, 3-Ring adverse effects, Middle Aged, Young Adult, Viral Load drug effects, HIV Infections drug therapy, Tenofovir therapeutic use, Tenofovir administration & dosage, Tenofovir analogs & derivatives, Emtricitabine therapeutic use, Emtricitabine administration & dosage, Anti-HIV Agents therapeutic use, Anti-HIV Agents administration & dosage, Pyridones administration & dosage, Alanine therapeutic use, Alanine administration & dosage
- Abstract
Introduction: Rapid initiation of ART after HIV diagnosis is recommended for individual and public health benefits. However, certain clinical and ART-related considerations hinder immediate initiation of therapy., Methods: An open-label, single-arm, single-centre 48-week prospective clinical trial involving ART-naïve HIV-diagnosed adults who started bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) within a week from the first hospital visit, before the availability of baseline laboratory and genotype results. The primary aim was to determine the proportion of people with at least one condition that would hinder immediate initiation of any recommended ART regimen other than BIC/FTC/TAF. Clinicaltrials.gov: NCT04416906., Results: We included 100 participants: 79% men, 64% from Latin America, median age 32 years. According to European AIDS Clinical Society (EACS) and US Department of Health and Human Services 2023 guidelines, 11% (95%CI 6; 19) of participants had at least one condition that made any ART different from BIC/FTC/TAF less appropriate for a rapid ART strategy. Seventy-nine percent of the people started BIC/FTC/TAF within the first 48 hours of their first hospital visit. There were 16 early discontinuations (11 lost to follow-up). By week 48, 92% (95%CI 86; 98) of the participants of the ITT population with observed data achieved viral suppression. Eight grade 3-4 adverse events (AEs), five serious AEs and six ART-related AEs were identified. Adherence remained high., Conclusions: BIC/FTC/TAF is an optimal treatment for rapid initiation of ART. However, additional strategies to improve retention in care must be implemented., (© 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.)
- Published
- 2024
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