There are about 155 million visits to hospital emergency departments in the United States each year, many of them by people who rarely access other forms of health care. That makes the ED a natural place to try to detect undiagnosed diseases – including hepatitis C, a potentially dangerous infection.
But when EDs screen patients for hepatitis C, is it more effective to offer tests for everyone, or only people with established risk factors?
That’s a question addressed by a recent clinical trial led by University of Colorado Anschutz School of Medicine faculty that encompassed nearly 148,000 patient visits at three high-volume, urban EDs, including Denver Health Medical Center.
The study also looked at how likely it was for ED patients diagnosed with hepatitis C to complete follow-up care. And those results proved to be disappointing.
Co-principal investigators of the trial were Jason Haukoos, MD, MSc, professor in the CU Anschutz Department of Emergency Medicine; and Sarah Rowan, MD, associate professor of medicine in the CU Anschutz Department of Medicine’s Division of Infectious Diseases. Both practice at Denver Health.
They say that to their knowledge, the trial was the largest and most comprehensive evaluation of hepatitis C screening strategies in EDs to date.
The trial was called DETECT, or Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes for Hepatitis C. A paper on the trial results for screening was published recently in the Journal of the American Medical Association.
Haukoos and Rowan formed a research partnership years ago to investigate how EDs can be a powerful setting for detecting infectious diseases like hepatitis C, HIV, and others, and for steering patients into treatment.
In EDs, “our priority is taking care of acutely ill and injured people, but there’s another layer to EDs,” Haukoos says. “If you’re able to integrate hepatitis C screening into an ED, for example, and identify patients who are otherwise undiagnosed, and then link them to treatment, there’s an opportunity for big impact.”
Hepatitis C is a viral infection that spreads through contact with the blood of someone who has the virus, known as HCV. It slowly damages the liver, often without symptoms for years.
“The worst and most commonly feared outcome of chronic hep C is cirrhosis of the liver – liver scarring – and that can lead to liver failure and liver cancer,” Rowan says.
In the U.S., hepatitis C is most often spread by sharing equipment used for injection drug use with someone who has HCV – an association that leads to considerable stigma surrounding the infection, Rowan says. It can also be spread through an accidental stick with an unsterilized needle, being tattooed or pierced with unsterilized tools, through condomless sex, sharing a razor or other personal care item exposed to blood, or from mother to baby during pregnancy or childbirth.
Before 1992, hepatitis C was commonly spread through blood transfusions and organ transplants. For that reason and others, about three out of four people in the U.S. with chronic hepatitis C were born between 1945 and 1965. Since 1992, there has been routine testing of the U.S. blood supply for HCV.
An estimated 4 million Americans have hepatitis C, yet many don't know it because of a lack of obvious symptoms they might associate with it.
Modern antiviral medications can cure hepatitis C in most people, but the benefit of the cure is limited when significant liver damage has already occurred. Health authorities currently recommend that all adults be screened for HCV at least once in their lives, with additional testing for those at greater risk.
“A whole lot of people can benefit from medication – if we can find them and help them access treatment,” Rowan says.
→ VIDEO: Expanding Treatment of Hepatitis C Among Patients with Substance Use Disorder
The DETECT trial was conducted over nearly three years at the EDs of Denver Health, Johns Hopkins Hospital in Baltimore, and the University of Mississippi Medical Center in Jackson, Mississippi.
It was a pragmatic trial – a study designed to evaluate the effectiveness of interventions in real-world clinical situations involving diverse populations, rather than in ideal, controlled settings.
In the trial, 147,498 patient visits by adults were randomly assigned to one of two screening groups, or arms:
Screening was voluntary, and many ED patients in the study opted out of being tested.
The trial team reported that nontargeted screening led to more new hepatitis C diagnoses — 154 versus 115 in the targeted group, a 34% advantage. But they also found that the percentage of newly diagnosed hepatitis C cases was higher in the targeted arm (2.5% of those tested) than in the nontargeted group (1.6%).
The study concluded that “a nontargeted screening approach was superior to targeted screening for identifying new HCV infections” at large, urban EDs like the three in the trial, based on the larger number of infections detected.
But Haukoos says that some smaller EDs, including those in rural areas, may still choose to offer screening only to at-risk people. “For some, costs may be an issue, and they may not have the resources to offer testing more broadly,” he says. “There’s still value in that.”
Another paper from the DETECT trial that’s under pre-publication review will analyze the cost effectiveness of nontargeted versus targeted HCV screening.
→ How a Cure for Hepatitis C Changed the Face of Liver Transplantation
While the trial showed the effectiveness of screening for hepatitis C in EDs, it also produced discouraging results on the rate of follow-up care.
Researchers tracked patients for 18 months after their hepatitis C diagnosis. They found that of those newly diagnosed with the infection, only about 20% linked up with a hepatitis C specialist, about 16% started treatment, about 12% finished treatment, and just 9% had a documented cure, meaning that the virus was undetectable in the blood 12 weeks or more after completing antiviral therapy.
The follow-up treatment rates were similar for both targeted and nontargeted arms of the trial. Patients who disclosed recent use of injected drugs connected to care less often than others.
The study concluded that there’s an “urgent need” for expanded approaches to improve treatment rates once identification occurs in the ED.
Rowan says it’s ironic that treatment follow-up rates are so low, given how much better today’s hepatitis C therapies are than they used to be.
“The treatment used to be with interferon, which made people feel really sick for sometimes as long as a year. It was only effective for half the people at most, so it was a horrible option,” she says. “But now that we have better, well-tolerated medications, there’s a heartbreaking disconnect between the number of people who need treatment and the number of people who get treatment.”
In a subsequent trial, the results of which Haukoos and Rowan hope to publish later this year, they examined methods of linking patients with untreated hepatitis C to treatment. Their preliminary results show advantages of using patient navigators to help people access care, compared with standard ED referral without navigation.
And in a forthcoming study for which Haukoos and Rowan are seeking grant funding, they hope to explore the effectiveness of treating newly diagnosed hepatitis C right in the ED. “We want to look into bringing treatment to the bedside in the ED, which we think is the next wave, based on the results of DETECT,” Haukoos says.
For Rowan, the bottom line of this research is demonstrating the potential of EDs to help people in new ways. “Even if not all emergency departments offer nontargeted hep C testing to all adults, this helps to elevate the conversation and show how the ED can be a really impactful venue on this.”
Illustration at top provided by the U.S. Centers for Disease Control and Prevention.