Background Long-acting injectable antiretroviral therapy (LAI-ART) is approved for treatment-naïve or experienced people living with HIV (PLWH) based on trials that only included participants with viral suppression. We performed the first LAI-ART demonstration project to include PLWH unable to achieve or maintain viral suppression due to challenges adhering to oral ART. Methods Ward 86 is a large HIV clinic in San Francisco that serves publicly insured or underinsured patients. We started patients on LAI-ART via a structured process of provider referral, multidisciplinary review (MD, RN, pharmacist), and monitoring for on-time injections. Inclusion criteria were willingness to receive monthly injections and a reliable contact method. Descriptive statistics evaluated program outcomes. Results Between June 2021-April 2022, 51 patients initiated LAI-ART, with 39 receiving at least two follow-up injections by database closure (median age 46; 90% cisgender men, 61% non-White, 41% marginally housed, 54% currently using stimulants). Of 24 patients initiating injections with viral suppression (median CD4 706), 100% (95% CI 86-100%) maintained viral suppression. Of 15 patients initiating injections with detectable viremia (median CD4 99, mean log10 viral load 4.67 SD 1.16), 12 (80%; 95% CI 55-93%) achieved viral suppression and the other 3 had a 2-log viral load decline by a median of 22 days. Conclusions This small demonstration project of LAI-ART in a diverse group of patients with high levels of substance use and marginal housing demonstrated promising early treatment outcomes, including in those with detectable viremia due to adherence challenges. More data on LAI-ART in hard-to-reach populations are needed.

中文翻译：

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城市艾滋病诊所首个针对可检测到和未检测到艾滋病病毒血症者的长效注射抗逆转录病毒治疗示范项目


背景 基于仅纳入接受病毒抑制治疗的受试者的试验，长效注射抗逆转录病毒疗法 (LAI-ART) 被批准用于未经治疗或有治疗经验的艾滋病毒感染者 (PLWH)。我们开展了第一个 LAI-ART 示范项目，其中包括由于口服 ART 面临的挑战而无法实现或维持病毒抑制的 PLWH。方法 Ward 86 是旧金山的一家大型 HIV 诊所，为公共保险或保险不足的患者提供服务。我们通过提供者转诊、多学科审查（医学博士、注册护士、药剂师）和按时注射监测的结构化流程开始患者接受 LAI-ART。纳入标准是愿意每月接受注射和可靠的接触方法。描述性统计评估了计划结果。结果 2021 年 6 月至 2022 年 4 月期间，51 名患者开始了 LAI-ART，其中 39 名患者在数据库关闭时接受了至少两次后续注射（中位年龄 46 岁；90% 顺性别男性，61% 非白人，41% 边缘居住，54目前使用兴奋剂的百分比）。在 24 名开始注射病毒抑制的患者中（中位 CD4 706），100% (95% CI 86-100%) 维持病毒抑制。在 15 名开始注射且可检测到病毒血症的患者中（中位 CD4 99，平均 log10 病毒载量 4.67 SD 1.16），12 名（80%；95% CI 55-93%）实现了病毒抑制，另外 3 名病毒载量下降了 2 个对数中位数为 22 天。结论 LAI-ART 的这一小型示范项目在物质使用水平较高且住房边缘化的不同患者群体中表现出良好的早期治疗结果，包括那些因依从性挑战而出现可检测到的病毒血症的患者。需要更多关于难以接触人群的 LAI-ART 数据。