To identify, manage HDV, ‘the simple approach is to just screen’ all patients with HBV
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Over recent years, there has been increased interest and attention to hepatitis delta virus, as we are beginning to understand that this is a real problem that at the moment is under-addressed and under-identified.
In part, this is due to inconsistent screening guidelines and inadequate rates of screening. Our team, led by Lauren Alpert, a student at Icahn School of Medicine at Mount Sinai, presented an abstract at EASL 2024 that looked at screening rates, as well as predictors of screening, using a regional database called INSIGHT in New York City. We found that among patients with a documentation of hepatitis B surface antigen in the system, almost half had never had HDV screening, and fewer ever received HDV RNA testing. Furthermore, proximity to large health systems as well as the community deprivation index, which measures neighborhood resources, appeared to influence who gets screened for HDV. These add to the concern that not only is screening for HDV inadequate, but there appear to be disparities in terms of who is actually being screened.
As Nancy S. Reau, MD, FAASLD, AGAF, mentioned in this Healio Exclusive, AASLD guidance recommends risk-based screening and details risk factors that should prompt providers to screen for HDV. But, we found in our research that providers are not always following this guidance. For example, patients with HBV who have a low viral load but high alanine aminotransferase levels are generally more likely to have HDV, but providers are more commonly screening those with high HBV DNA levels.
This suggests that increased provider education is needed to help inform who should be screened and how to screen adequately. Given that HDV is a rare disease and not always front of mind, the solution many are advocating for is reflex testing, which means that all patients within a health system who screen positive for HBV are automatically screened for HDV. This is something we at Icahn School of Medicine at Mount Sinai are in the process of implementing, with our preliminary results submitted for presentation at The Liver Meeting 2024.
Treatment Options on the Horizon
Hepcludex (bulevirtide, Gilead Sciences) is an exciting treatment option that is approved for use in Europe. We have both clinical trial and real-world data that have shown its benefit, but the challenge is that it is not currently available in the U.S. However, you may be able obtain it on a case-by-case basis through Gilead’s Compassionate Use program.
In addition, Vir Biotechnology presented data at EASL 2024 from the phase 2 SOLSTICE trial that evaluated the use of two different agents — a small interfering RNA and a monoclonal antibody — that worked in combination to improve outcomes in HDV.
My hope is that, as long as results pan out in phase 3 study, this will follow bulevirtide as another potential treatment option for patients with HDV.
Advice to the Provider
The most important message is that when you see a patient with HBV, whether it be for the first time or as an existing patient in your practice, make sure to screen them for HDV at least once. They may not have the classic risk factors and, especially if you are not aware of all the relevant risk factors, the simple approach is just to screen once. Knowledge of HDV status will influence your treatment approach.
The other message I have is that, in addition to hopefully gaining access to bulevirtide in the not-too-distant future, there are ongoing clinical trials for HDV treatment. Whether your site participates in these trials or trials are just being conducted at institutions in your geographic vicinity, it is important to consider offering your patients that opportunity.
- References:
- Alpert L, et al. Patient, provider and neighborhood-level factors associated with hepatitis delta testing in an academic health system. Presented at: EASL Congress; June 5-8, 2024; Milan (hybrid).
- Asselah T, et al. Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR-2218) in participants with chronic hepatitis delta virus infection: preliminary results from the phase 2 SOLSTICE trial in noncirrhotic and compensated cirrhotic participants. Presented at: EASL Congress; June 5-8, 2024; Milan (hybrid).
- For more information:
- Tatyana Kushner, MD, MSCE, is an associate professor in the division of liver diseases at Icahn School of Medicine at Mount Sinai. She can be reached at tatyana.kushner@mssm.edu.
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