دورية أكاديمية
أعرض في EDS

Rapid ART initiation with bictegravir/emtricitabine/tenofovir alafenamide in individuals presenting with advanced HIV disease (Rainbow study).

التفاصيل البيبلوغرافية
العنوان: Rapid ART initiation with bictegravir/emtricitabine/tenofovir alafenamide in individuals presenting with advanced HIV disease (Rainbow study).
المؤلفون: Camici M; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy. Electronic address: marta.camici@inmi.it., Gagliardini R; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Lanini S; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Del Duca G; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Mondi A; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Ottou S; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Plazzi MM; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., De Zottis F; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Pinnetti C; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Vergori A; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Grilli E; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Mastrorosa I; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Mazzotta V; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Paulicelli J; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Bellagamba R; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Cimini E; Laboratory of Cellular Immunology and Pharmacology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Tartaglia E; Laboratory of Cellular Immunology and Pharmacology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Notari S; Laboratory of Cellular Immunology and Pharmacology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Tempestilli M; Laboratory of Cellular Immunology and Pharmacology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Cicalini S; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Amendola A; Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Abbate I; Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Forbici F; Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Fabeni L; Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Girardi E; Scientific Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Vaia F; General Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Maggi F; Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy., Antinori A; Clinical and Research Infectious Diseases Department, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Rome, Italy.
المصدر: International journal of antimicrobial agents [Int J Antimicrob Agents] 2024 Jan; Vol. 63 (1), pp. 107049. Date of Electronic Publication: 2023 Dec 05.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Publishers Country of Publication: Netherlands NLM ID: 9111860 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-7913 (Electronic) Linking ISSN: 09248579 NLM ISO Abbreviation: Int J Antimicrob Agents Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Amsterdam : Elsevier Science Publishers, c1991-
مواضيع طبية MeSH: HIV Infections*/drug therapy , Anti-HIV Agents*/therapeutic use , Piperazines* , Alanine* , Amides* , Heterocyclic Compounds, 3-Ring*, Tenofovir/*analogs & derivatives, Humans ; Female ; Prospective Studies ; Emtricitabine/therapeutic use ; Adenine/therapeutic use ; Pyridones/therapeutic use ; Drug Combinations ; Heterocyclic Compounds, 4 or More Rings/therapeutic use
مستخلص: Background: A rapid ART initiation approach can be beneficial in people with advanced HIV disease, in consideration of their high morbidity and mortality. The aim of our study was to evaluate the feasibility, efficacy and safety of rapid ART start with BIC/FTC/TAF in this setting.
Methods: Pilot, single-centre, single-arm, prospective, phase IV clinical trial conducted in a tertiary Italian hospital. Thirty ART-naïve people presenting with advanced HIV-1 diagnosis (defined as the presence of an AIDS-defining event and/or CD4 cell count <200 µL), were enrolled. Main exclusion criteria were active tuberculosis, cryptococcosis and pregnant/breastfeeding women. BIC/FTC/TAF was started within 7 days from HIV diagnosis. The primary endpoint was clinical or virologic failure (VF). Immunological parameters, safety, feasibility, neurocognitive performances and patient-reported outcomes were assessed as well.
Results: Over the study period, 40 (34%) of 116 patients diagnosed with HIV infection at INMI Spallanzani had advanced disease, of whom 30 (26%) were enrolled. The proportion of participants with HIV-RNA <50 cp/mL was 9/30 (30%) at week (w) 4, 19/30 (63%) at w12, 24/30 (80%) at w24, 23/30 (77%) at w36 and 27/30 (90%) at w48. Two unconfirmed VF occurred. No ART discontinuation due to toxicity or VF was observed. No ART modification was performed based on the review of genotype and no mutations for the study drugs were detected. Mean CD4 cells count changed by 133 cells/μL at BL to 309 cells/μL at w 48 and 83% of participants had a CD4 > 200 cells/µL at w 48. Two participants developed IRIS and one was diagnosed with disseminated TB and needed an ART switch.
Interpretations: Our results support the feasibility, efficacy and safety of BIC/FTC/TAF as a rapid ART strategy in patients with advanced HIV disease.
(Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
فهرسة مساهمة: Keywords: AIDS; Advanced-naïve; BIC/FTC/TAF; HIV infection; IRIS; Rapid ART strategy
المشرفين على المادة: EL9943AG5J (tenofovir alafenamide)
8GB79LOJ07 (bictegravir)
G70B4ETF4S (Emtricitabine)
JAC85A2161 (Adenine)
0 (Pyridones)
0 (Drug Combinations)
0 (Heterocyclic Compounds, 4 or More Rings)
0 (Anti-HIV Agents)
0 (Piperazines)
99YXE507IL (Tenofovir)
OF5P57N2ZX (Alanine)
0 (Amides)
0 (Heterocyclic Compounds, 3-Ring)
تواريخ الأحداث: Date Created: 20231206 Date Completed: 20240115 Latest Revision: 20240115
رمز التحديث: 20240115
DOI: 10.1016/j.ijantimicag.2023.107049
PMID: 38056572
قاعدة البيانات: MEDLINE
الوصف
تدمد:1872-7913
DOI:10.1016/j.ijantimicag.2023.107049