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Hepatitis D Virus
2025 Case Definition

Hepatitis D Virus
2025 Case Definition
NOTE: A surveillance case definition is a set of uniform criteria used to define a disease for public health surveillance. Surveillance case definitions enable public health officials to classify and count cases consistently across reporting jurisdictions. Surveillance case definitions are not intended to be used by healthcare providers for making a clinical diagnosis or determining how to meet an individual patient’s health needs.

CSTE Position Statement(s)

24-ID-06

Background

HDV infection, often referred to as hepatitis D, can cause severe liver damage and even death among persons living with hepatitis B virus (HBV) infection. HDV infection in the United States (U.S.) is believed to be rare, but due to limited and non-uniform testing and reporting practices, the exact burden of HDV infection is unknown. A 2024 study by Quest Diagnostics found among 2,646 hepatitis B surface antigen (HBsAg) positive specimens, 1.6% were HDV antibody positive (indicating past or current infection); among those HDV antibody positive, 39% were found to be HDV RNA positive (indicating current infection)1. Identifying HDV infection is vital in the management of individuals living with HBV infection. HDV infection can accelerate progression of HBV infection, resulting in liver cirrhosis and liver failure. Despite its importance, HDV testing practices remain inconsistent. In one study, it was found that among a cohort of 157,333 persons with HBV infection, only 6.7% had received testing for HDV infection.1 A similar study of Veterans Affairs data found that among 12,002 persons with HBV infection, only 19.7% had received testing for HDV infection.2 While there are no FDA-approved HDV assays at this time, the availability of serologic and molecular HDV assays at commercial laboratories has increased in recent years. Commercially available assays were developed in a manner consistent with CLIA requirements and are intended for clinical purposes. HDV antigen testing is not a reliable marker of current HDV infection, and HDV IgM antibody, like many IgM tests, has less than ideal specificity.3 For this reason, only the total anti-HDV and HDV RNA tests are included in the criteria for case classification. The proposed standardized case definition will facilitate uniform public health surveillance, offering comprehensive insights into the burden of HDV infection and enable jurisdictions to estimate prevalence, analyze trends, and make informed decisions regarding public health interventions and resource allocation.

Laboratory Criteria

Confirmatory Laboratory Evidence:*

  • Detection of HDV RNA by nucleic acid test (qualitative, quantitative, or genotype testing).

Presumptive Laboratory Evidence:*

  • Total antibody to hepatitis D virus (total anti-HDV) is reactive.

* Note: The categorical labels used here to stratify laboratory evidence are intended to support the standardization of case classifications for public health surveillance. The categorical labels should not be used to interpret the utility or validity of any laboratory test methodology.

Criteria to Distinguish a New Case from an Existing Case

A case of HDV infection should be enumerated only if the person has not been previously enumerated as a case of HDV infection.

Case Classification

Probable

  • Meets presumptive laboratory evidence.

Confirmed

  • Meets confirmatory laboratory evidence.

Case Classification Comments

CDC does not have Office of Management and Budget approval under the Paperwork Reduction Act to collect HDV infection case notifications through NNDSS and will not plan to perform data collection at this time.

References

  1. Marlowe, E. M., Swanson, B. E., Realegeno, S. E., Kagan, R. M., & Meyer, W. A. (2024, March 3). Epidemiologic Burden of Hepatitis D Virus in the United States. Epidemiologic burden of hepatitis D virus in the United States. https://www.natap.org/2024/CROI/croi_228.htm
  2. Wong, R. J., Kaufman, H. W., Niles, J. K., Chen, C., Yang, Z., Kapoor, H., & Cheung, R. (2022). Low performance of hepatitis delta virus testing among two national cohorts of chronic hepatitis B patients in the United States. American Journal of Gastroenterology, 117(12), 2067–2070. https://doi.org/10.14309/ajg.0000000000001947
  3. Tseligka, E. D., Clément, S., & Negro, F. (2021). HDV pathogenesis: Unravelling Ariadne's thread. Viruses, 13(5), 778. https://doi.org/10.3390/v13050778
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National Notifiable Diseases Surveillance System (NNDSS)

NNDSS receives and shares case data from state, local, and territorial health departments to help public health monitor, control, and prevent serious diseases.

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