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 147?498 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, 73?847 patients underwent nontargeted screening, resulting in 9867 (13.4%) tested for HCV and 154 new HCV diagnoses, whereas 73?651 patients underwent targeted screening and 23?400 (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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04003454.
| Specialty Area | Score |
|---|---|
| Gastroenterology | |
| Infectious Disease | |
| Emergency Medicine | |
| Hospital Doctor/Hospitalists | |
| Internal Medicine |
The non-targeted screening strategy increased the number of hepatitis C diagnoses compared with the targeted strategy. However, its clinical impact, cost-effectiveness, the phenomenon of over-diagnosis, and the effects of false positives and false negatives were not assessed. Therefore, the conclusion that the non-targeted strategy is superior remains highly questionable.
Sadly this paper dealing with a huge cohort of patients, provides no direction for increasing the treatment and cure rates in this population.
This provides evidence in favor of universal screening in emergency departments to maximize diagnosis but highlights a major issue in the subsequent care cascade.
As an Internist-Hepatologist, I think this article is very useful for everyday clinical practice.
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