近日，美国丹佛健康公共卫生研究所Sarah E. Rowan团队研究了急诊科丙型肝炎筛查的随机临床试验结果。这一研究成果发表在2025年7月9日出版的《美国医学会杂志》上。

识别丙型肝炎病毒（HCV）感染者是一项公共卫生重点工作。急诊科（EDs）一直是筛查工作的重点，因为它们服务于大量通常无法在其他地方获得医疗保健的高危患者。然而，在ED环境中HCV筛查的最佳方法仍然未知。

为了在假设非靶向筛查比靶向筛查发现更多新诊断的情况下，评估急诊科丙型肝炎筛查的有效性，研究组在科罗拉多州丹佛市、马里兰州的巴尔的摩以及密西西比州的杰克逊3个城市急诊科进行了一项前瞻性、多中心、实用的随机临床试验。招募患者年龄≥18岁，排除危重疾病、无法提供同意或先前诊断为HCV的患者。

作为常规急诊科护理的一部分，患者被随机分配接受非靶向筛查，其中不考虑风险进行HCV检测，或接受靶向筛查，其中根据风险评估进行检测。主要终点是新诊断的HCV感染（检测到RNA）。次要结局是重复HCV诊断；HCV检测提供、验收和完成；HCV基因型与纤维化分期；丙型肝炎病毒治疗连续体的组成部分；以及18个月的全因死亡率。2025年1月至3月，通过意向治疗分析，使用95% CI的相对风险（RR）和Fisher精确检验进行分析。

总共147498例患者随机就诊(中位[IQR]年龄41[29-57]岁；男性51.5%；黑人42.3%，西班牙裔20.9%，白人32.2%)。其中，73847例患者接受了非靶向筛查，9867例（13.4%）患者接受了HCV检测，154例新诊断为HCV。73651名患者接受了靶向筛查，23400例（31.8%）被确定有HCV感染的危险因素，导致4640例（6.3%）患者接受HCV检测，115例新诊断为HCV。

与靶向HCV筛查相比，非靶向HCV筛查发现的HCV感染新诊断明显增加(RR, 1.34；P = .02)。在新诊断为HCV感染的患者中，来自非靶向和靶向筛查组的一小部分患者接受了随访护理（分别为19.5%和24.3%），开始了直接作用抗病毒（DAA）治疗（15.6%对17.4%），完成了DAA治疗（12.3%对12.2%），并在12周（SVR12）获得了持续的病毒学应答（9.1%对9.6%）。

研究结果表明，在这项多中心随机临床试验中，在3个城市急诊科发现的患者中，非靶向筛查方法优于靶向筛查方法来识别新的HCV感染。从诊断到SVR12的患者数量大幅减少，这凸显了对HCV治疗创新模式的迫切需求。

附：英文原文

Title: Hepatitis C Screening in Emergency Departments: The DETECT Hep C Randomized Clinical Trial

Author: Jason Haukoos, Richard E. Rothman, James W. Galbraith, Emily Hopkins, Yu-Hsiang Hsieh, Carolynn Lyle, Stephanie Gravitz, Kevin F. Kamis, Douglas A. E. White, Michael S. Lyons, Edward M. Gardner, Alia A. Al-Tayyib, Allison L. Sabel, Benjamin P. Linas, Jake R. Morgan, David L. Wyles, Sarah E. Rowan, DETECT Hep C Screening Trial Investigators, Amy Adler, Musheng Alishahi, Gideon Avornu, Simon Barinas, Alexis Becerra, Erika Becerra-Ashby, Meghan Bellamy, Samantha Bot, Alexander Boyle, Annetta M. Bracey, Dante Brown, Meggan Bucossi, Claudia Camacho, Alicia Cupelo, Deanna Curbeam, Larsan Czoty, Gaby Dashler, Carrie Anne De Gruiter, Pamela Doyle, Amy Eichler, Heather Gardner, Trevor Hill, Mauren Henley, Sophia Henry, David Higgins, Rachel Houk, Nyah Johnson, Austin Jones, Kathleen Joseph, Gabor Kelen, Alex Kile, Rachel Kurzdorfer, Roger J. Lewis, Janet Liebl, Mia Lundin, Barbara Maliszewski, Taylor McCormick, Robert McGoey, Catherine McKenzie, Matthew Minturn, Evangelia Murray, Deanna Myer, Kenddra Neumann, Erin Niell, Cole Ossian, Rebekah Peacock, Danielle Perez, Erin Ricketts, Benji Riggan, Sherry Riser, Genie Roosevelt

Issue&Volume: 2025-07-09

Abstract:

Importance  Identification of individuals with hepatitis C virus (HCV) infection is a public health priority. Emergency departments (EDs) have been a focus of screening efforts, as they serve large numbers of at-risk patients who commonly do not access health care elsewhere. However, the optimal approach to HCV screening in ED settings remains unknown.

Objective  To evaluate the effectiveness of HCV screening in EDs with the hypothesis that nontargeted screening identifies more new diagnoses than targeted screening.

Design, Setting, and Participants  Prospective, multicenter, pragmatic randomized clinical trial performed at 3 urban EDs in Denver, Colorado; Baltimore, Maryland; and Jackson, Mississippi. Patients were 18 years or older, with exclusions for critical illness, inability to provide consent, or previously diagnosed HCV.

Interventions  As part of routine ED care, patients were randomly assigned to undergo either nontargeted screening, in which HCV testing was offered regardless of risk, or targeted screening, in which testing was offered based on risk assessment.

Main Outcomes and Measures  The primary outcome was newly diagnosed HCV infection (RNA detected). Secondary outcomes were repeat HCV diagnoses; HCV test offer, acceptance, and completion; HCV genotype and fibrosis staging; components of the HCV care continuum; and all-cause mortality through 18 months of follow-up. Analyses were conducted from January to March 2025 by intention-to-treat analysis, using relative risk (RR) with 95% CIs and Fisher exact tests.

Results  A total of 147498 patient visits were randomized (median [IQR] age, 41 [29-57] years; 51.5% male; and 42.3% Black, 20.9% Hispanic, and 32.2% White). Of these, 73847 patients underwent nontargeted screening, resulting in 9867 (13.4%) tested for HCV and 154 new HCV diagnoses, whereas 73651 patients underwent targeted screening and 23400 (31.8%) were identified to have risk factors for HCV infection, resulting in 4640 (6.3%) patients tested for HCV and 115 new HCV diagnoses. Compared with targeted HCV screening, nontargeted HCV screening identified significantly more new diagnoses of HCV infection (RR, 1.34 [95% CI, 1.05-1.70]; P=.02). Among patients newly diagnosed with HCV infection, small proportions from the nontargeted and targeted screening groups were linked to follow-up care (19.5% vs 24.3%, respectively), initiated direct-acting antiviral (DAA) treatment (15.6% vs 17.4%), completed DAA treatment (12.3% vs 12.2%), and attained sustained virologic response at 12 weeks (SVR12) (9.1% vs 9.6%).

Conclusions and Relevance  In this multicenter randomized clinical trial, a nontargeted screening approach was superior to targeted screening for identifying new HCV infections among patients seen in 3 urban EDs. The substantial decrease in patients who went from diagnosis to SVR12 highlights an urgent need for innovative models of HCV treatment.

DOI: 10.1001/jama.2025.10563

Source: https://jamanetwork.com/journals/jama/fullarticle/2836253