A multicenter randomized clinical trial has demonstrated that nontargeted hepatitis C virus (HCV) screening in emergency departments significantly outperforms risk-based targeted screening for identifying new infections, according to findings from the DETECT Hep C Trial published in the Journal of the American Medical Association.
The study, conducted across three high-volume emergency departments at Denver Health Medical Center, Johns Hopkins Hospital, and the University of Mississippi Medical Center, represents the largest and most comprehensive evaluation of HCV screening strategies in emergency departments to date.
Trial Design and Patient Population
The prospective, pragmatic randomized trial enrolled 147,498 patient visits from November 2019 through August 2022. Patients aged 18 years and older who provided consent, did not have critical illness, and had not been previously diagnosed with HCV were randomly assigned to one of two screening approaches.
In the nontargeted screening group (73,847 patients), HCV testing was offered regardless of risk factors. The targeted screening group (73,651 patients) received testing based on established risk criteria including birth between 1945 and 1965, injection drug use, intranasal drug use, tattoos or piercings in unregulated settings, or blood transfusion or organ transplant before 1992.
The study population had a median age of 41 years, with 51.5% male patients and 42.3% Black patients, reflecting the diverse demographics typically seen in urban emergency departments.
Screening Effectiveness Results
Nontargeted screening demonstrated superior performance in identifying new HCV infections. Of the 73,847 patients in the nontargeted group, 9,867 (13.4%) were tested for HCV, resulting in 154 new diagnoses. In comparison, among the 73,651 patients in the targeted screening group, 23,400 (31.8%) were identified as having risk factors, but only 4,640 (6.3%) were actually tested, yielding 115 new HCV diagnoses.
The prevalence of new HCV diagnoses was 0.21% in the nontargeted screening group versus 0.16% in the targeted screening group, representing a difference of 0.05% (95% CI, 0.01%-0.1%). Nontargeted screening was associated with a significantly greater number of new HCV diagnoses, with a relative risk of 1.34 (95% CI, 1.05-1.70; P = 0.02).
Critical Gaps in Care Continuum
Despite the improved detection rates, both screening approaches revealed concerning deficiencies in the hepatitis C care continuum. Among patients newly diagnosed with HCV, the proportion who successfully progressed through each stage of care was alarmingly low in both groups.
For linkage to follow-up care, only 19.5% of nontargeted screening patients and 24.3% of targeted screening patients were successfully connected to ongoing care. The rates declined further for treatment initiation, with 15.6% of nontargeted and 17.4% of targeted screening patients beginning direct-acting antiviral (DAA) treatment.
Treatment completion rates were similarly low, with 12.3% of nontargeted and 12.2% of targeted screening patients completing their DAA regimens. Most concerning, only 9.1% of patients identified through nontargeted screening and 9.6% of those identified through targeted screening achieved sustained virologic response at 12 weeks (SVR12), the standard measure of HCV cure.
Clinical Implications and Future Directions
According to the World Health Organization, an estimated 50 million people globally have chronic HCV infection, with approximately 1 million new infections occurring annually. The availability of short-course oral, curative pangenotypic HCV direct-acting antiviral treatment regimens has made elimination of hepatitis C a realistic public health goal.
Emergency departments have emerged as important venues for HCV screening because they serve large numbers of at-risk patients who commonly do not access healthcare elsewhere. The current study's findings support the implementation of nontargeted screening approaches in these settings.
However, the dramatic attrition from diagnosis to cure represents a critical challenge that extends beyond screening strategy. As study author Jason Haukoos, M.D., from Denver Health and the University of Colorado Anschutz Medical Campus, noted with colleagues, "The substantial decrease in patients who went from diagnosis to SVR12 highlights an urgent need for innovative models of HCV treatment."
The researchers emphasized that while nontargeted screening proves superior for case identification, the healthcare system must address the systemic barriers that prevent patients from completing the journey from diagnosis to cure. This may require integrated care models, simplified treatment protocols, and enhanced patient navigation services specifically designed for emergency department-identified patients.
