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Not actual patient.

Testing & Diagnosis

Patients with HBV should be screened according to guideline recommendations

Not actual patients.

Test first for HDV antibodies,
then test for HDV RNA to diagnose active HDV infection1


The presence of anti-HDV is evidence of a past or ongoing HDV infection2

In a study, anti-HDV titers declined over time in resolved HBV/HDV infections2

For patients testing negative but have ongoing risk factors, consider periodic retesting for HDV antibodies1

Recommended tests for HDV*:

  • Total anti-HDV (CPT code: 86692) Hallmark of prior or current infection
  • HDV RNA PCR (CPT code: 87798, 87799) Marker of active infection and useful for monitoring therapy

Anti-HDV tests

TEST CODE 4990 86692 Quest Diagnostics Hepatitis D Virus (HDV) Antibody, Total Hepatitis Delta Virus Antibody Hepatitis D Total Hepatitis D Virus Total Antibodies, Serum HDV Antibody Total 86692 ARUP Laboratories 86692 BioAgilytix 86692 Mayo Clinic Laboratories 86692 Viracor 0020799 99202 TEST NAME SUPPLIER CPT CODE

HDV RNA PCR tests

TEST CODE 87799 Quest Diagnostics Hepatitis D Virus RNA, Qualitative, Real-time PCR Hepatitis D Virus RNA, Quantitative, Real-time PCR Hepatitis Delta Virus by Quantitative PCR Hepatitis D Virus (HDV) Qualitative Real-time RT-PCR 87799 Quest Diagnostics 87799 ARUP Laboratories 87798 Viracor TEST NAME SUPPLIER CPT CODE 34469 37889 3900 2013881

*This is a select list of codes and suppliers that may be used for ordering tests related to screening and diagnosing potential patients with HDV infection. Please consult the latest ICD-10-CM for a full list of ICD-10 codes. This is for your information only. 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.

SCREENING GUIDELINES FOR HEPATITIS DELTA

Guidelines
Recommendation

American Association for the Study of Liver Diseases (AASLD)1

  • HBsAg+ patients with hepatitis delta risk factors

Asian Pacific Association for the Study of the Liver (APASL)3

  • Patients with chronic HBV and chronic liver disease

European Association for the Study of the Liver (EASL)4

  • All patients infected with HBV
SCREENING GUIDELINES FOR HEPATITIS DELTA

Guidelines

American Association for the Study of Liver Diseases (AASLD)1

Recommendation

  • HBsAg+ patients with hepatitis delta risk factors

Guidelines

Asian Pacific Association for the Study of the Liver (APASL)3

Recommendation

  • Patients with chronic HBV and chronic liver disease

Guidelines

European Association for the Study of the Liver (EASL)4

Recommendation

  • All patients infected with HBV

AASLD recommends screening HBV patients with the
following risk factors1:


Persons born in regions with reported high hepatitis delta virus (HDV) endemicity

Persons with multiple sexual partners or any history of sexually transmitted disease

Men who have sex with men

Persons who have ever injected drugs

Persons with high ALT or AST with low or undetectable HBV DNA

Persons infected with the hepatitis C virus or HIV

Map of endemic areas5


Map of endemic countries

The largest populations affected by HDV infection are
in Asia and Africa5

Persons from endemic regions account for about 52% of hepatitis
delta cases in the US6


Pie chart of 52% persons from endemic regions 48% persons from the U.S.

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ALT=alanine aminotransferase; anti-HDV=hepatitis delta virus antibody; AST=aspartate aminotransferase; HBsAg=hepatitis B surface antigen; HBV=hepatitis B virus; HDV=hepatitis delta virus; PCR=polymerase chain reaction.

References: 1. 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;67:1560-1599. doi:10.1002/hep.29800 2. Patel EU, Thio CL, Boon D, Thomas DL, Tobian AAR. Prevalence of hepatitis B and hepatitis D virus infections in the United States, 2011–2016. Clin Infect Dis. 2019;69(4):709-712. doi:10.1093/cid/ciz001 3. Sarin SK, Kumar M, Lau GK, et al. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016;10(1):1-98. doi:10.1007/s12072-015-9675-4 4. European Association for the Study of the Liver. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-398. doi:10.1016/j.jhep.2017.03.021 5. 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 6. Data on file. HDV immigration data analysis. June 2021.