For your patients with HBV, HEPATITIS DELTA adds layers of risk for disease progression1
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BECAUSE OF THE SEVERITY OF HDV, SCREENING IS URGENTLY NEEDED
Recent guidance advises HDV screening for all HBsAg-positive patients2_4
Studies show that the prevalence of HDV in the US varies significantly due to inconsistent screening5
In recent studies, prevalence estimates for HDV in the US range from 1% to 5% of patients with HBV5
Results from a 2023 retrospective analysis of 1444 patients with chronic hepatitis B in the US indicated that 18% of patients with HDV would be missed under US-recommended risk-based screening approaches6
The study analyzed medical records for 11,190 patients diagnosed with chronic hepatitis B infection in a tertiary health system in a multicultural urban area in the US from January 2016 to December 2021. A total of 1444 of the patients with chronic hepatitis B were screened for HDV and 88 (6%) were positive for HDV antibodies.6
Persons from endemic regions are at the most significant risk for hepatitis delta3
In 2022, it was estimated that ~65,000 foreign-born individuals in the US were living with HDV infection7
Endemic regions8:
- Africa (West Africa, Horn of Africa)
- Asia (Central and Northern Asia, Vietnam, Mongolia, Pakistan, Japan, Taiwan)
- Pacific Islands (Kiribati, Nauru)
- Middle East (all countries)
- Eastern Europe (Eastern Mediterranean regions, Turkey)
- South America (Amazon basin)
- Other (Greenland)
HDV only infects people with HBV9
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HDV infection leads to a faster progression towards liver-related death and hepatocellular carcinoma (HCC)9
Patients infected with HBV/HDV can have more severe disease compared to individuals with HBV monoinfection1,10
2-3× more likely to develop cirrhosis
2-3× higher risk of death or liver transplantation
3-6× higher risk for hepatocellular carcinoma
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Recent guidance advises HDV screening for all HBsAg-positive patients2_4
All HBsAg-positive individuals should be screened for HDV at least once.4
– 2025 HBV Guidelines from the European Association for the Study of the Liver (EASL)
- The American Association for the Study of Liver Diseases (AASLD) recommends testing of HBsAg-positive persons at risk for HDV, which include8:
- Persons born in HDV endemic regions:
- Africa (West Africa, Horn of Africa)
- Asia (Central and Northern Asia, Vietnam, Mongolia, Pakistan, Japan, Taiwan)
- Pacific Islands (Kiribati, Nauru)
- Middle East (all countries)
- Eastern Europe (Eastern Mediterranean regions, Turkey)
- South America (Amazon basin)
- Other (Greenland)
- Low HBV DNA with unexplained ALT elevations should be considered
Map of Endemic Areas11
How to Screen for HDV12
Convenient reflex testing is available through the following laboratories
| Laboratory | Test Code |
|---|---|
| Quest Diagnostics | 37231 |
| Labcorp | 550672* |
| Mayo Clinic | AHDV |
| ARUP Laboratories | 3006379 |
*Must be ordered in combination with test code 144012 (HDV antibody total).
Reflex testing consists of 2 tests:
Anti-HDV antibody (CPT 86692)
if positive
HDV RNA viral load (CPT 87523)
If CPT 87523 (HDV RNA Quantitative Real-Time PCR) is not available, try to use CPT 87798 (HDV RNA PCR)
Note: The above lists are not exhaustive and are for informational purposes only. Please consult the latest test and CPT codes for a full list. Each provider must make an individualized decision for each patient’s needs. Gilead does not guarantee the coverage or reimbursement of any item or service through the use of these codes.
ALT, alanine aminotransferase; ARUP, Associated Regional and University Pathologists; HCV, hepatitis C virus; HIV, human immunodeficiency virus; STD, sexually transmitted disease.
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Resources
References
References:
1. Da BL, Heller T, Koh C. Hepatitis D infection: from initial discovery to current investigational therapies. Gastroenterol Rep (Oxf). 2019;7(4):231-245. doi:10.1093/ gastro/goz023 2. Ahn J, Gish RG. Hepatitis D virus: a call to screening. Gastroenterol Hepatol (NY). 2014;10(10):647-686. 3. Terrault NA, Ghany MG. Enhanced screening for hepatitis D in the USA: overcoming the delta blues. Dig Dis Sci. 2021;66:2483-2485. doi:10.1007/s10620-020-06584-w 4. European Association for the Study of the Liver. EASL Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2025;83(2):502-583. doi: 10.1016/ j.jhep.2025.03.018 5. Gish RG, Cohen C, Holden LR, et al. A call to reclassify the delta hepatitis virus as an orphan disease. Hepatol Commun. 2025;9:e0746. doi:10.1097/HC9.0000000000000746 6. Nathani R, Leibowitz R, Giri D, et al. The Delta Delta: Gaps in screening and patient assessment for hepatitis D virus infection. J Viral Hepat. 2023;30:195-200. doi:10.1111/jvh.13779 7. Wong RJ, Brosgart C, Wong SS, et al. Estimating the prevalence of hepatitis delta virus infection among adults in the United States: A meta-analysis. Liver Int. 2024;44(7):1715-1734. doi:10.1111/liv.15921 8. Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560-1599. doi:10.1002/hep.29800 9. World Health Organization. Hepatitis D fact sheet. Updated July 25, 2025. Accessed September 18, 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d 10. Brancaccio G, Fasano M, Grossi A, Santantonio TA, Gaeta GB. Clinical outcomes in patients with hepatitis D, cirrhosis and persistent hepatitis B virus replication, and receiving long-term tenofovir or entecavir. Aliment Pharmacol Ther. 2019;49(8):1071-1076. doi:10.1111/apt.15188 11. Miao Z, Zhang S, Ou X, et al. Estimating the global prevalence, disease progression, and clinical outcome of hepatitis delta virus infection. J Infect Dis. 2020;221(10):1677-1687. doi:10.1093/ infdis/jiz633 12. European Association for the Study of the Liver. EASL Clinical Practice Guidelines on hepatitis delta virus. J Hepatol. 2023;79(2):433-460. doi:10.1016/j.jhep.2023.05.001