Hepatitis delta

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1FDA treatments34Active trials52Specialists8Treatment centers2Financial resources

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Hepatitis delta, also known as hepatitis D or HDV infection, is a liver infection caused by the hepatitis D virus (HDV). What makes this disease unique is that it can only infect people who already have hepatitis B (HBV). The hepatitis D virus is considered a "defective" virus because it needs the hepatitis B virus to survive and multiply in the body. You can get both viruses at the same time (called coinfection) or catch hepatitis D after you already have chronic hepatitis B (called superinfection). Hepatitis delta is considered the most severe form of viral hepatitis. It causes inflammation and damage to the liver that is often more aggressive than hepatitis B alone. Symptoms can include fatigue, nausea, loss of appetite, abdominal pain (especially in the upper right area), yellowing of the skin and eyes (jaundice), dark urine, and joint pain. Many people may not notice symptoms right away, but the disease can silently damage the liver over time. Hepatitis delta significantly increases the risk of developing cirrhosis (scarring of the liver), liver failure, and liver cancer compared to having hepatitis B alone. The disease can progress to cirrhosis much faster — sometimes within just 5 to 10 years. Treatment options have historically been very limited, but a newer medication called bulevirtide (Hepcludex) has been approved in Europe for the treatment of chronic hepatitis D. Pegylated interferon alfa has also been used, though it has significant side effects and limited success rates. Research into new therapies is ongoing and represents an area of great need for patients.

Also known as:

Key symptoms:

Fatigue and feeling very tiredYellowing of the skin and eyes (jaundice)Dark-colored urinePale or clay-colored stoolsNausea and vomitingLoss of appetitePain in the upper right side of the abdomenJoint painUnexplained weight lossSwelling of the abdomen from fluid buildup (ascites)Easy bruising or bleedingConfusion or difficulty thinking clearly (in advanced disease)Itchy skinFever

Clinical phenotype terms (18)— hover any for plain English
Elevated circulating alanine aminotransferase concentrationHP:0031964Fulminant hepatitisHP:0004787Elevated circulating aspartate aminotransferase concentrationHP:0031956MalaiseHP:0033834Hepatocellular carcinomaHP:0001402
Inheritance

Sporadic

Usually appears on its own, not inherited from a parent

Age of Onset

Variable

Can begin at different ages, from infancy through adulthood

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
Apr 2026Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D

Shanghai HEP Pharmaceutical Co., Ltd. — PHASE3

TrialNOT YET RECRUITING
Mar 2026A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)

Huahui Health — PHASE3

TrialNOT YET RECRUITING
Feb 2026Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

Mirum Pharmaceuticals, Inc. — PHASE2, PHASE3

TrialRECRUITING
Feb 202610119473 -VIROMARKERS HDV Biomarkers Study

University of Rome Tor Vergata

TrialNOT YET RECRUITING
Feb 2026Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D

Research Center of Periodontal-Systemic Interactions

TrialRECRUITING
Feb 2026"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort"

ANRS, Emerging Infectious Diseases

TrialNOT YET RECRUITING
Jan 2026A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

Mirum Pharmaceuticals, Inc. — PHASE3

TrialRECRUITING
Oct 2025"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

TrialRECRUITING
Sep 2025Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

TrialRECRUITING
Sep 2025Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France

Hospices Civils de Lyon — NA

TrialNOT YET RECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

1 available

HepaGam B

hepatitis B immune globulin (human)· Cangene Corporation
treatment of household exposure to persons with acute HBV infection in infants less than 12 months old whose mother or primary caregiver is positive for HBsAg, and other household contacts with an ide

treatment of household exposure to persons with acute HBV infection in infants less than 12 months old whose mother or primary caregiver is positive for HBsAg, and other household contacts with an identifiable blood exposure to the index patient

Clinical Trials

20 recruitingView all trials with filters →
Other20 trials
Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
Actively Recruiting
PI: Francesca Romana Ponziani (Fondazione Policlinico A. Gemelli IRCCS) · Sites: Roma · Age: 1899 yrs
Find HDV and Determine Its Status in Turkey
Actively Recruiting
PI: Mustafa Kemal Çelen, MD (Dicle University, Medical Faculty, Department of I) · Sites: Ankara; Diyarbakır · Age: 1899 yrs
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
Active
PI: Benjamin Maasoumy, MD (Hannover Medical School) · Sites: Hanover, Lower Saxony
ePro Diary - HDV ( MACROLIVER )
Actively Recruiting
· Sites: Bergamo, Italy · Age: 1899 yrs
DELTA DESCRIBE: the French Collaborative Project
Actively Recruiting
PI: Véronique Loustaud-Ratti, Pr (University Hospital, Limoges) · Sites: Limoges · Age: 1899 yrs
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Active
PI: Michael J Vinikoor, MD (University of Alabama at Birmingham) · Sites: Lusaka, Lusaka Province · Age: 1899 yrs
Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients
Actively Recruiting
· Sites: Stockholm · Age: 1899 yrs
Evaluation of Patients With Liver Disease
Actively Recruiting
PI: T. Jake Liang, M.D. (National Institute of Diabetes and Digestive and K) · Sites: Bethesda, Maryland · Age: 2100 yrs
Thailand HDV Cohort
Actively Recruiting
PI: Anchalee Avihingsanon, MD, PhD (HIV-NAT, Thai Red Cross - AIDS Research Centre) · Sites: Bangkok, Bangkok; Bangkok, Bangkok +2 more · Age: 1899 yrs
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Actively Recruiting
· Sites: Strasbourg · Age: 1899 yrs
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Actively Recruiting
· Sites: Milan · Age: 1899 yrs
HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection
Actively Recruiting
PI: Jürgen Rockstroh, MD (University Hospital, Bonn) · Sites: Bonn, North Rhine-Westphalia · Age: 1899 yrs
Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
Active
· Sites: Ho Chi Minh City · Age: 1699 yrs
National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Actively Recruiting
PI: Fabien ZOULIM (Hôpital de la Croix-Rousse) · Sites: Angers; Annecy +36 more · Age: 1899 yrs
D-SOLVE Cohorts (Cohort a and B)
Actively Recruiting
PI: Markus Cornberg (Hannover Medical School) · Sites: Hanover; Milan +2 more · Age: 1899 yrs
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Actively Recruiting
· Sites: Milan, MI · Age: 1899 yrs
Standardising Care for Hepatitis Delta in the Netherlands
Actively Recruiting
· Sites: Rotterdam · Age: 1899 yrs
Study of Bulevirtide in Participants With Chronic Hepatitis D Infection
Active
PI: Gilead Study Director (Gilead Sciences) · Sites: Graz; Hall in Tirol +51 more · Age: 1899 yrs
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
Actively Recruiting
· Sites: Milan · Age: 1899 yrs
HDV Screening Study
Actively Recruiting
PI: Lai Hung Grace Wong (Chinese University of Hong Kong) · Sites: Hong Kong · Age: 1899 yrs

Specialists

Showing 25 of 52View all specialists →
JM
Jürgen Rockstroh, MD
Specialist
PI on 1 active trial
MD
Michael P. Manns, Prof. Dr.
GRESHAM, OR
Specialist
PI on 1 active trial
DM
David Apelian, MD, PhD, MBA
BOONTON, NJ
Specialist
PI on 1 active trial
TM
T. Jake Liang, M.D.
Specialist
PI on 1 active trial
TM
Theo Heller, M.D.
Bethesda, Maryland
Specialist

Rare Disease Specialist

PI on 8 active trials
LW
Lai Hung Grace Wong
Specialist
PI on 1 active trial59 Hepatitis delta publications
MM
Michael J Vinikoor, MD
CHAPEL HILL, NC
Specialist
PI on 4 active trials
MM
Marc G Ghany, M.D.
BETHESDA, MD
Specialist
PI on 4 active trials
JD
Junqi Niu, Dr.
Specialist
PI on 1 active trial
FZ
Fabien ZOULIM
Specialist
PI on 1 active trial1 Hepatitis delta publication
PP
Pavel Bogomolov, PhD
Specialist
PI on 2 active trials
OJ
Oyunbileg Janchiv
Specialist
PI on 1 active trial
VM
Victor Pantea, MD
Specialist
PI on 2 active trials
YP
Young-Suk Lim, M.D., Ph.D.
Specialist
PI on 2 active trials
HM
Heiner Wedemeyer, MD,PhD
Specialist
PI on 1 active trial
ES
Eleonora Sfreddo
Specialist
PI on 1 active trial1 Hepatitis delta publication
JF
Johane P Allard, MD, FRCPC
Specialist
PI on 1 active trial
PP
Pierre O SELLIER, M.D., Ph.D
Specialist
PI on 1 active trial
ND
Nariman Gulyamov, DSci
Specialist
PI on 1 active trial
NC
Nicola Coppola
WILKES BARRE, PA
Specialist
PI on 1 active trial
MR
Mario Rizzetto
Specialist
PI on 1 active trial
YC
Yutian Chong
Specialist
PI on 1 active trial
MP
Margarita Papatheodoridi
Specialist
3 Hepatitis delta publications
JF
John F Flaherty
Specialist
3 Hepatitis delta publications
VD
Vanessa Stadlbauer-Köllner, Univ. Prof. Dr.
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Financial Resources

2 resources

Ocuflox Ophthalmic Solution

Allergan, Inc.

Ocuflox Ophthalmic Solution — Contact Allergan, Inc.

Unverified — confirm before calling
Patient Assistance
Manufacturer Program
Accepting applications

Gamunex-C

Grifols Therapeutics, Inc.

Gamunex-C — Contact Grifols Therapeutics, Inc.

Unverified — confirm before calling
Patient Assistance
Manufacturer Program
Accepting applications

Travel Grants

No travel grants are currently matched to Hepatitis delta.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Hepatitis delta

Disease timeline:

New recruiting trial: ePro Diary - HDV ( MACROLIVER )

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Thailand HDV Cohort

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Find HDV and Determine Its Status in Turkey

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

A new clinical trial is recruiting patients for Hepatitis delta

New recruiting trial: D-SOLVE Cohorts (Cohort a and B)

A new clinical trial is recruiting patients for Hepatitis delta

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.How advanced is my liver disease, and do I have any signs of cirrhosis?,Am I a candidate for bulevirtide (Hepcludex) or other specific hepatitis D treatments?,How often will I need blood tests and imaging to monitor my liver?,Should my family members be tested for hepatitis B and D?,Are there any medications, supplements, or foods I should avoid?,At what point would I need to be evaluated for a liver transplant?,Are there any clinical trials for new hepatitis D treatments that I could participate in?

Common questions about Hepatitis delta

What is Hepatitis delta?

Hepatitis delta, also known as hepatitis D or HDV infection, is a liver infection caused by the hepatitis D virus (HDV). What makes this disease unique is that it can only infect people who already have hepatitis B (HBV). The hepatitis D virus is considered a "defective" virus because it needs the hepatitis B virus to survive and multiply in the body. You can get both viruses at the same time (called coinfection) or catch hepatitis D after you already have chronic hepatitis B (called superinfection). Hepatitis delta is considered the most severe form of viral hepatitis. It causes inflammation

How is Hepatitis delta inherited?

Hepatitis delta follows a sporadic inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

Are there clinical trials for Hepatitis delta?

Yes — 20 recruiting clinical trials are currently listed for Hepatitis delta on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Hepatitis delta?

25 specialists and care centers treating Hepatitis delta are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Hepatitis delta?

3 patient support programs are currently tracked on UniteRare for Hepatitis delta. See the treatments and support programs sections for copay assistance, eligibility, and contact details.