Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study)

IF 4.8 2区医学 Q1 INFECTIOUS DISEASES

International Journal of Infectious Diseases Pub Date : 2025-06-18 DOI:10.1016/j.ijid.2025.107961

Roberta Gagliardini , Marta Camici , Simone Lanini , Rita Bellagamba , Sandrine Ottou , Maria Maddalena Plazzi , Alessandra Vergori , Valentina Mazzotta , Annalisa Mondi , Marisa Fusto , Jessica Paulicelli , Massimo Tempestilli , Carmela Pinnetti , Elisabetta Grilli , Ilaria Mastrorosa , Federico De Zottis , Giulia Del Duca , Andrea Antinori

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引用次数: 0

Abstract

Objectives

No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) given once daily (OD) or on alternate days (ATAD) to BIC/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in virologically suppressed people with HIV (PWH).

Methods

A pilot, single-arm, prospective study was conducted.

Results

Overall, 234 PWH were enrolled. 217 of 234 (92.7%, 95% confidence interval [CI], 88.6-95.7%) participants had HIV-RNA <40 cp/ml at 48 weeks. Virological failure occurred in three participants, none with documented resistance, and all resuppressed without antiretroviral therapy change. After 48 weeks, a slight increase in cluster of differentiation (CD)4 cell count was observed from the baseline (+ 59 cells/mmc, 95% CI, 31; 86, P <0.001), but not in CD4/CD8 ratio. A slight increase in creatinine (mean change +0.11 mg/dl, 95% CI 0.10; 0.13, P <0.001) and a decrease in total cholesterol (mean change −8 mg/dl, 95% CI −14; −3, P = 0.001) were also observed.

Conclusions

Our data showed that BIC/FTC/TAF demonstrated high virologic and immunologic efficacy and an excellent safety profile.

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病毒学抑制的HIV感染者从依非韦伦/恩曲他滨/替诺福韦二氧吡酯（EFV/FTC/TDF）改用比替格拉韦/恩曲他滨/替诺福韦丙烯胺（B/F/TAF）：来自一项非随机临床试验（EBONY研究）的结果。

目的：以前没有研究专门探讨从依非韦伦到含比替格拉韦的三药抗逆转录病毒治疗方案的转换。该研究的目的是评估病毒学抑制的HIV感染者（PWH）从每日一次（OD）或隔天（ATAD）给予依非韦伦/恩曲他滨/替诺福韦二氧吡酯富马酸（EFV/FTC/TDF）治疗转换为比替重韦/恩曲他滨/替诺福韦alafenamide （B/F/TAF）的疗效和安全性结果。方法：进行一项先导、单臂、前瞻性研究。结果：共有234名PWH入组。234名参与者中有217名（92.7%,95% CI, 88.6-95.7%）携带HIV-RNA。结论：我们的数据显示BIC/FTC/TAF具有很高的病毒学和免疫功效，并且具有良好的安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Infectious Diseases 医学-传染病学

CiteScore

18.90

自引率

2.40%

发文量

1020

审稿时长

30 days

期刊介绍： International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.