Identify Hepatitis D (HDV) Early

EARLY IDENTIFICATION OF HDV STARTS WITH  SCREENING ALL PATIENTS WITH HBV¹

Chronic HDV Is the Most Aggressive Form of Viral Hepatitis, Accelerating
Progression to Cirrhosis, Hepatic Decompensation, and Liver Failure^2-5

Delays in diagnosis can lead to serious consequences for patients with chronic HDV⁶

70%-80% of patients with chronic HDV develop cirrhosis within 5-10 years.

There is 2-3x higher risk of liver transplant or death in patients with HDV vs HBV monoinfection.

More than 50% of patients die of liver disease within 10 years of chronic HDV diagnosis.

HDV infection occurs only in people who are infected
with the Hepatitis B Virus⁷

Serious Liver Disease May Develop Earlier in Patients With Chronic HDV⁹

Compared with HBV monoinfection, chronic HDV is associated with a more severe clinical course and faster progression to cirrhosis, which may increase the risk of serious liver-related complications earlier in the disease course.⁹

Chronic HDV can progress to cirrhosis at a younger age than
chronic HBV monoinfection.^9,10

Screen Early and Help Make a Difference for Your Patients With HBV¹

Recent guideline recommendations support screening all patients who are HBsAg+^1,11,12

AGA 2025

HDV Guidelines

WHO 2024

HBV Guidelines

EASL 2023

HDV Guidelines

THE 2018 AASLD guidelines recommend risk-based screening
in HBsAg+ individuals with risk factors^13,b

How to Screen for HDV

Reflex testing^c is available through these laboratories:

Laboratory	Test code
Quest Diagnostics	37231
Labcorp	550672^d
Mayo Clinic Laboratories	AHDV
ARUP Laboratories	3006379

Consider repeat HDV testing for those with ongoing risk behaviors^11,e

Note: The above list is not exhaustive and is 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.

Anti-HDV=marker of HDV exposure; HDV RNA=marker of active HDV infection if detectable.

Universal screening of patients with HBV identifies
INDIVIDUALS with HDV infection and
may help prevent serious consequences^2,3,14,15,f

AASLD=American Association for the Study of Liver Diseases; AGA=American Gastroenterological Association; ARUP=Associated Regional and University Pathologists; CPT=Current Procedural Terminology; EASL=European Association for the Study of the Liver; HBsAg+=hepatitis B surface antigen positive; PCR=polymerase chain reaction; WHO=World Health Organization.

^aPatients with chronic HDV superinfection.

^bHDV screening is not specifically addressed in 2025 AASLD HBV treatment guidelines.¹⁶

^cDouble-reflex testing (HBsAg+ >> anti-HDV antibody+ >> HDV RNA) is available from ARUP Laboratories (test code 3018776).

^dMust be ordered in combination with test code 144012 (HDV antibody total).¹⁴

^ePer AGA HDV guidelines, populations with ongoing risk behaviors include people who inject drugs and/or who are at risk of acquiring sexually transmitted diseases.¹¹

^fCompared to risk-based testing of HBsAg+ patients.

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INDICATION¹

HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.

This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information for HEPCLUDEX, including BOXED WARNING and Instructions for Use.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B

Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted.

Warnings and Precautions

Hypersensitivity Reactions Including Anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment.

Adverse Reactions

Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus.

Dosage and Administration

Dosage in adults: 8.5 mg once daily administered by subcutaneous injection.
HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown.
In all patients, manage the underlying hepatitis B virus (HBV) infection as clinically appropriate.

Pregnancy and Lactation

Pregnancy: There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Lactation: There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition.

EARLY IDENTIFICATION OF HDV STARTS WITH SCREENING ALL PATIENTS WITH HBV1

Chronic HDV Is the Most Aggressive Form of Viral Hepatitis, Accelerating Progression to Cirrhosis, Hepatic Decompensation, and Liver Failure2-5

HDV infection occurs only in people who are infected with the Hepatitis B Virus7

Serious Liver Disease May Develop Earlier in Patients With Chronic HDV9

Compared with HBV monoinfection, chronic HDV is associated with a more severe clinical course and faster progression to cirrhosis, which may increase the risk of serious liver-related complications earlier in the disease course.9

Chronic HDV can progress to cirrhosis at a younger age than chronic HBV monoinfection.9,10

Screen Early and Help Make a Difference for Your Patients With HBV1