Ramers Christian B, Vawter Natalie, Northrup Adam, Klaman Stacey L, Lewis Sydney V, Tam Aaron, Del Aguila Carolina, Lewis Robert, Mendez Blanca, Reyes Letty, Matthews Eva, Rojas Sarah, Godino Job G
Global Medical Affairs, Gilead Sciences, Foster City, California, USA.
Laura Rodriguez Research Institute, Family Health Centers of San Diego, San Diego, California, USA.
Open Forum Infect Dis. 2025 May 22;12(6):ofaf302. doi: 10.1093/ofid/ofaf302. eCollection 2025 Jun.
Hepatitis C virus (HCV) infection disproportionately affects people who inject drugs (PWID), particularly people experiencing homelessness, who face significant barriers to testing and treatment. Simplified testing and treatment algorithms, including the use of mobile medical units (MMUs), may improve access to care for this population. This study evaluated the effectiveness of a simplified HCV testing and treatment algorithm with integrated care delivered via MMU to unhoused PWID in an urban United States setting.
This pragmatic, randomized controlled trial compared a simplified MMU care model with usual care among 201 PWID who tested positive for HCV antibody. Patients were randomized into simplified MMU or usual care. The primary outcome was treatment initiation within 6 months. Secondary outcomes included treatment completion, sustained virologic response at 12 weeks (SVR12), and initiation of medication-assisted treatment for opioid use disorder.
Of 98 patients with confirmed HCV RNA, 33% in the MMU group initiated treatment compared to 24% in the usual care group ( = .4). Treatment completion and SVR12 rates were higher in the usual care group (16% vs 10% and 12% vs 4%, respectively), but differences were not statistically significant. MMUs facilitated faster treatment initiation but encountered challenges with patient retention and follow-up.
While the MMU model demonstrated potential for improving rapid access to HCV treatment, overall treatment initiation, retention, and cure rates remained low. A critical need remains to develop approaches that more closely approximate a test-and-treat model to increase treatment initiation and completion and achieve elimination in unhoused PWID.
NCT04741750.
丙型肝炎病毒（HCV）感染对注射吸毒者（PWID）的影响尤为严重，尤其是那些无家可归的人，他们在检测和治疗上面临重大障碍。简化的检测和治疗方案，包括使用移动医疗单位（MMU），可能会改善这一人群获得医疗服务的机会。本研究评估了一种简化的HCV检测和治疗方案结合通过MMU提供的综合护理对美国城市地区无家可归的PWID的有效性。
这项实用的随机对照试验比较了201名HCV抗体检测呈阳性的PWID中简化的MMU护理模式与常规护理。患者被随机分为简化的MMU组或常规护理组。主要结局是在6个月内开始治疗。次要结局包括治疗完成、12周时的持续病毒学应答（SVR12）以及开始针对阿片类药物使用障碍的药物辅助治疗。
在98名确诊HCV RNA的患者中，MMU组33%的患者开始治疗，而常规护理组为24%（P = 0.4）。常规护理组的治疗完成率和SVR12率更高（分别为16%对10%和12%对4%），但差异无统计学意义。MMU促进了更快的治疗开始，但在患者留存和随访方面遇到了挑战。
虽然MMU模式显示出改善快速获得HCV治疗的潜力，但总体治疗开始、留存和治愈率仍然较低。迫切需要开发更接近检测即治疗模式的方法，以提高治疗开始率和完成率，并在无家可归的PWID中实现消除。
NCT04741750。
