hepatitis D virus infection
diseaseOn this page
Also known as HDVHepatitis DHepatitis D virushepatitis deltaHepatitis delta virus caused hepatitisHepatitis delta virus hepatitishepatitis type D
Summary
hepatitis D virus infection (MONDO:0005789) is a disease and 51 clinical trials. Top therapeutic interventions include bulevirtide, lonafarnib, and ursodiol. A subtype of viral hepatitis — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Prevalence: 1-5 / 10 000 (Europe) [Orphanet-validated]
- Phenotypes (HPO): 18
- Clinical trials: 51
Clinical features
Epidemiology
Prevalence records
1 prevalence record(s), Orphanet:
| Type | Class | Value | Geography | Validation |
|---|---|---|---|---|
| Point prevalence | 1-5 / 10 000 | 40 | Europe | Validated |
Signs & symptoms
Clinical features (HPO)
18 HPO clinical features (Orphanet curated; top 18 by frequency):
| HPO ID | Term | Frequency |
|---|---|---|
| HP:0001394 | Cirrhosis | Frequent (30-79%) |
| HP:0012115 | Hepatitis | Frequent (30-79%) |
| HP:0031964 | Elevated circulating alanine aminotransferase concentration | Frequent (30-79%) |
| HP:0000952 | Jaundice | Occasional (5-29%) |
| HP:0000978 | Bruising susceptibility | Occasional (5-29%) |
| HP:0001289 | Confusion | Occasional (5-29%) |
| HP:0001399 | Hepatic failure | Occasional (5-29%) |
| HP:0001892 | Abnormal bleeding | Occasional (5-29%) |
| HP:0001945 | Fever | Occasional (5-29%) |
| HP:0002017 | Nausea and vomiting | Occasional (5-29%) |
| HP:0002027 | Abdominal pain | Occasional (5-29%) |
| HP:0002039 | Anorexia | Occasional (5-29%) |
| HP:0004396 | Poor appetite | Occasional (5-29%) |
| HP:0004787 | Fulminant hepatitis | Occasional (5-29%) |
| HP:0012378 | Fatigue | Occasional (5-29%) |
| HP:0031956 | Elevated circulating aspartate aminotransferase concentration | Occasional (5-29%) |
| HP:0033834 | Malaise | Occasional (5-29%) |
| HP:0001402 | Hepatocellular carcinoma | Very rare (<1-4%) |
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | hepatitis D virus infection |
| Mondo ID | MONDO:0005789 |
| EFO | EFO:0007304 |
| MeSH | D003699 |
| Orphanet | 402823 |
| DOID | DOID:2047 |
| SNOMED CT | 707341005 |
| UMLS | C0011226 |
| MedGen | 4182 |
| GARD | 0021716 |
| NORD | 2020 |
| Is cancer (heuristic) | no |
Also known as: HDV · Hepatitis D · Hepatitis D virus · hepatitis delta · Hepatitis delta virus caused hepatitis · Hepatitis delta virus hepatitis · hepatitis type D
Disease family
This is a subtype of viral hepatitis. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by body system or component › digestive system disorder › hepatobiliary disorder › liver disorder › hepatitis › viral hepatitis › hepatitis D virus infection
Related subtypes (5): Epstein-Barr virus hepatitis, hepatitis C virus infection, hepatitis B virus infection, hepatitis E virus infection, hepatitis A virus infection
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
Drugs indicated for this disease
0 approved, 6 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.
| Drug | Development status |
|---|---|
| Lonafarnib | Phase 3 (in late-stage trials) |
| PEGINTERFERON ALFA-2A | Phase 3 (in late-stage trials) |
| PEGINTERFERON ALFA-2B | Phase 3 (in late-stage trials) |
| PEGINTERFERON LAMBDA-1A | Phase 3 (in late-stage trials) |
| Ritonavir | Phase 3 (in late-stage trials) |
| Tenofovir Anhydrous | Phase 3 (in late-stage trials) |
Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Bulevirtide, Ezetimibe, ROPEGINTERFERON ALFA-2B, Ribavirin, Tenofovir Alafenamide, Tenofovir Disoproxil, Terfenadine, Ursodiol.
Clinical trials & evidence
Clinical trials
Clinical trials: 51.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| Not specified | 31 |
| PHASE2 | 14 |
| PHASE1 | 2 |
| PHASE4 | 1 |
| PHASE3 | 1 |
| PHASE2/PHASE3 | 1 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00117533 | PHASE4 | UNKNOWN | Pegylated Interferon Alfa-2b Plus Ribavirin in Chronic Hepatitis B and Delta |
| NCT07454837 | PHASE2/PHASE3 | RECRUITING | Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide |
| NCT03852719 | PHASE3 | COMPLETED | Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD) |
| NCT06505928 | PHASE2 | ACTIVE_NOT_RECRUITING | A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D |
| NCT06649266 | PHASE2 | ACTIVE_NOT_RECRUITING | Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D |
| NCT07096193 | PHASE1/PHASE2 | RECRUITING | Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus |
| NCT00001457 | PHASE2 | COMPLETED | Lamivudine for Chronic Hepatitis B |
| NCT00023322 | PHASE2 | COMPLETED | Pegylated Interferon to Treat Chronic Hepatitis D |
| NCT00932971 | PHASE2 | COMPLETED | HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis |
| NCT01495585 | PHASE2 | COMPLETED | Lonafarnib for Chronic Hepatitis D |
| NCT02511431 | PHASE2 | COMPLETED | Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir |
| NCT02577029 | PHASE2 | TERMINATED | Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) |
| NCT03099278 | PHASE2 | UNKNOWN | Ezetimibe for Patients With Chronic Hepatitis D |
| NCT03600714 | PHASE2 | COMPLETED | Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon |
| NCT03852433 | PHASE2 | COMPLETED | Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD) |
| NCT04847440 | PHASE2 | TERMINATED | A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection |
| NCT05467553 | PHASE2 | UNKNOWN | A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection |
| NCT05953545 | PHASE2 | WITHDRAWN | Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis |
| NCT01316185 | PHASE1 | TERMINATED | Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV) |
| NCT06740474 | PHASE1 | COMPLETED | A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants |
| NCT00001971 | Not specified | RECRUITING | Evaluation of Patients With Liver Disease |
| NCT04863703 | Not specified | ACTIVE_NOT_RECRUITING | Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D) |
| NCT05350865 | Not specified | RECRUITING | Thailand HDV Cohort |
| NCT05451082 | Not specified | NOT_YET_RECRUITING | Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China |
| NCT05903742 | Not specified | RECRUITING | Standardising Care for Hepatitis Delta in the Netherlands |
| NCT05936073 | Not specified | RECRUITING | DELTA DESCRIBE: the French Collaborative Project |
| NCT06051045 | Not specified | RECRUITING | Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients |
| NCT06122285 | Not specified | RECRUITING | Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD) |
| NCT06160635 | Not specified | RECRUITING | D-SOLVE Cohorts (Cohort a and B) |
| NCT06264583 | Not specified | RECRUITING | HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection |
| NCT06372990 | Not specified | RECRUITING | Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease |
| NCT06397859 | Not specified | RECRUITING | Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis |
| NCT06504485 | Not specified | RECRUITING | Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment |
| NCT06539052 | Not specified | NOT_YET_RECRUITING | MIGrant Reflex Test HDV (MIGRED) Project |
| NCT06834178 | Not specified | NOT_YET_RECRUITING | Non-interventional Study to Assess the Number of People With Untreated/Unknown HBV + HDV and HCV in South-East Austria |
| NCT06889805 | Not specified | RECRUITING | HDV Screening Study |
| NCT07038863 | Not specified | NOT_YET_RECRUITING | Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France |
| NCT07442760 | Not specified | RECRUITING | ePro Diary - HDV ( MACROLIVER ) |
| NCT07491848 | Not specified | RECRUITING | Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D |
| NCT02044055 | Not specified | COMPLETED | Mother-to-child Hepatitis D Transmission |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| BULEVIRTIDE | 4 | 11 |
| LONAFARNIB | 4 | 3 |
| URSODIOL | 4 | 2 |
| LAMIVUDINE | 4 | 1 |
| ROPEGINTERFERON ALFA-2B | 4 | 1 |
| TENOFOVIR ALAFENAMIDE | 4 | 1 |
| TERFENADINE | 4 | 1 |
| FOSCLEVUDINE ALAFENAMIDE | 2 | 1 |
| HEPALATIDE | 2 | 1 |
| IMDUSIRAN | 2 | 1 |
| lambda | 0 | 2 |
| CHEMBL5409583 | 0 | 1 |