Liu Yiyang, Fisk-Hoffman Rebecca J, Patel Maitri, Cook Robert L, Prosperi Mattia
Department of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, US.
AIDS Res Ther. 2025 Feb 1;22(1):9. doi: 10.1186/s12981-024-00690-9.
In January 2021, the United States (US) Food and Drug Administration (FDA) approved the first long-acting injectable antiretroviral therapy (LAI ART) regimen for the treatment of HIV providing an alternative to daily oral regimens. We analyzed electronic health records (EHRs) to provide real-world evidence of demographic and clinical characteristics associated with the receipt of LAI ART among people with HIV (PWH).
Leveraging EHRs from a large clinical research network in the Southern US - OneFlorida + linked with Medicaid (updated to 08/2022) - we identified a cohort of PWH who have been prescribed at least one dose of LAI ART since January 2021 and characterized their demographics, clinical characteristics, and HIV care outcomes.
A total of 233 LAI ART recipients were identified: 56.7% female, 45.1% aged 30 to 44, 51.3% non-Hispanic Black, 78.1% on Medicaid and 4.7% on private insurance. Approximately three-quarters of injections (71.2%) were received within 37 days of the previous dose, and 84.4% were received within 67 days. About 8% of LAI ART recipients did not have optimal care engagement the year before LAI ART initiation; one in five recipients had a diagnosis of alcohol or substance use disorder in lifetime. All achieved viral suppression (< 50 copies/mL) before starting LAI ART. Of a subset of patients with HIV viral load test records, only 1 record of virologic failure (viral load > 200 copies/ml) was observed after the initiation of LAI ART.
There has been an increasing trend of LAI ART initiation since approval. People with suboptimal care engagement and with substance use disorder in lifetime were not excluded from LAI ART treatment.
2021年1月，美国食品药品监督管理局（FDA）批准了首个用于治疗HIV的长效注射抗逆转录病毒疗法（LAI ART）方案，为每日口服方案提供了替代选择。我们分析了电子健康记录（EHR），以提供HIV感染者（PWH）接受LAI ART相关的人口统计学和临床特征的真实世界证据。
利用美国南部一个大型临床研究网络——OneFlorida + 与医疗补助计划（更新至2022年8月）相关联的电子健康记录，我们确定了一组自2021年1月以来至少开具过一剂LAI ART的PWH队列，并描述了他们的人口统计学、临床特征和HIV治疗结果。
共确定了233名LAI ART接受者：56.7%为女性，45.1%年龄在30至44岁之间，51.3%为非西班牙裔黑人，78.1%参加医疗补助计划，4.7%参加私人保险。大约四分之三的注射（71.2%）在前一剂注射后37天内进行，84.4%在67天内进行。约8%的LAI ART接受者在开始LAI ART前一年的治疗依从性不佳；五分之一的接受者一生中被诊断患有酒精或物质使用障碍。所有患者在开始LAI ART前均实现了病毒抑制（<50拷贝/毫升）。在有HIV病毒载量检测记录的部分患者中，开始LAI ART后仅观察到1例病毒学失败记录（病毒载量>200拷贝/毫升）。
自获批以来，LAI ART的启动呈上升趋势。治疗依从性不佳和一生中患有物质使用障碍的人并未被排除在LAI ART治疗之外。
