d'Arminio Monforte Antonella, Tavelli Alessandro, Quiros-Roldan Eugenia, Fabbiani Massimiliano, Ferrara Micol, Lo Caputo Sergio, Squillace Nicola, Rusconi Stefano, Ponzano Marta, Bovis Francesca, Antinori Andrea, Saracino Annalisa, Cozzi-Lepri Alessandro
Icona Foundation, Milan, Italy.
National PhD Programme in One Health approaches to infectious diseases and life science research, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.
HIV Med. 2025 Mar;26(3):489-499. doi: 10.1111/hiv.13740. Epub 2024 Dec 2.
Doravirine (DOR) is an attractive new option both for ART-naïve people with HIV (PWH) and those with suppressed HIV-RNA who seek treatment simplification. We used real-world data to examine the pattern of use of DOR-containing regimens in these settings.
All PWH enrolled in the Icona cohort after January 2020 who initiated a three-drug regimen (3-DR) with DOR or an integrase inhibitor (INSTI)-based regimen as first antiretroviral therapy (ART) or when switching ART, with HIV-RNA ≤50 copies/mL, were included. We used univariate and multivariable logistic regression models to identify demographic factors, immuno-virological and laboratory markers associated with the prescription of 3-DR DOR instead of INSTI-based regimens.
A total of 5803 PWH were included; 1958 were in the first regimen (80 DOR, 1,878 INSTI) and 3854 (387 DOR, 3,458 INSTI) were ART-experienced virologically suppressed. In the first line, 3-DR DOR was more frequently started in people who inject drugs, and its use was also associated with higher body mass index, higher low-density lipoprotein levels, and less advanced HIV disease compared with PWH initiating an INSTI-based regimen. In the switch setting, older age, Italian origin, higher estimated glomerular filtration rate and aspartate aminotransferase levels were all strongly associated with 3-DR DOR use, as well as higher a CD4/CD8 ratio (only vs. 3-DR INSTI), while the association with lipid abnormalities was attenuated.
Our analysis shows that among PWH in care in Italy, those with less advanced HIV disease but with other fragilities and potential risk factors for comorbidities are more likely to use DOR- than INSTI-based regimens, regardless of prior treatment history.
多拉韦林（DOR）对于未接受过抗逆转录病毒治疗（ART）的HIV感染者（PWH）以及那些HIV-RNA已被抑制且寻求简化治疗方案的患者来说，是一个有吸引力的新选择。我们利用真实世界数据来研究在这些情况下含DOR方案的使用模式。
纳入2020年1月后在伊科纳队列中登记的所有PWH，这些患者启动了含DOR的三联药物方案（3-DR）或基于整合酶抑制剂（INSTI）的方案作为初始抗逆转录病毒治疗（ART），或在切换ART时HIV-RNA≤50拷贝/mL。我们使用单变量和多变量逻辑回归模型来确定与开具3-DR DOR而非基于INSTI方案相关的人口统计学因素、免疫病毒学和实验室指标。
共纳入5803名PWH；1958名处于初始治疗方案（80名使用DOR，1878名使用INSTI），3854名（387名使用DOR，3458名使用INSTI）有ART经验且病毒学得到抑制。在一线治疗中，注射毒品者更常开始使用3-DR DOR，与启动基于INSTI方案的PWH相比，其使用还与更高的体重指数、更高的低密度脂蛋白水平以及不太严重的HIV疾病相关。在切换治疗的情况下，年龄较大、意大利裔、较高的估计肾小球滤过率和天冬氨酸转氨酶水平均与使用3-DR DOR密切相关，以及较高的CD4/CD8比值（仅与3-DR INSTI相比），而与脂质异常的关联则减弱。
我们的分析表明，在意大利接受治疗的PWH中，无论既往治疗史如何，HIV疾病不太严重但有其他脆弱性和合并症潜在风险因素的患者比使用基于INSTI方案的患者更有可能使用含DOR的方案。
