Clinical trial · Observational
Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Acid Malabsorption | — | UNRESOLVED | — |
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Fibrosis, Liver | — | UNRESOLVED | — |
| HBV | — | UNRESOLVED | — |
| HBV Coinfection | — | UNRESOLVED | — |
| HCV | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| HIV Infections | — | UNRESOLVED | — |
| Microbial Colonization | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Gut Microbiota in HBV-HDV Patients on Bulevirtide
- timeFrame
- 2-18 months
- description
- To describe the composition of the intestinal microbiota (IM)of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
- measure
- Bile Acids in HBV-HDV Patients on Bulevirtide
- timeFrame
- 2-18 months
- description
- To describe the composition of the fecal bile acids (BA) of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
- measure
- Inflammation in HBV-HDV Patients on Bulevirtide
- timeFrame
- 2-18 months
- description
- To describe the systemic inflammatory of patients with chronic hepatitis/compensated HBV-HDV cirrhosis receiving BLV 2 mg/day at enrollment and at weeks 12, 24, and 48.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A) * Positive HDV RNA within the 24 weeks prior to enrollment * Ongoing antiviral therapy for HBV at the time of enrollment * First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment * Caucasian ethnicity * Age ≥18 years * Normocaloric omnivorous diet * No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment * Signed informed consent Exclusion Criteria: * Decompensated liver cirrhosis (Child-Pugh Score B or C) * Patients without HBV-HDV-related infection/hepatitis/cirrhosis * Age ≤18 years * Pregnant or breastfeeding women * Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III/IV, COPD GOLD C-D) * Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition
References
Publications (0)
Data not yet available