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

NCT07429864 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-02-24

No results posted yet for this study

Summary

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

  • HBV
  • HBV Coinfection
  • HCV
  • HIV Infections
  • Hepatocellular Carcinoma
  • Cirrhosis, Liver
  • Fibrosis, Liver
  • Bile Acid Malabsorption
  • Microbial Colonization

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Francesca Romana Ponziani · Fondazione Policlinico A. Gemelli IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429864 on ClinicalTrials.gov