RecruitingNCT07429864

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

20 participants

Start Date

Sep 24, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a new hepatitis D treatment called bulevirtide (Hepcludex) affects gut bacteria (the microbiome) and bile acids in patients with chronic hepatitis D. Hepatitis D is a severe liver infection that can only occur in people already infected with hepatitis B. **You may be eligible if...** - You are 18 years old or older - You have chronic hepatitis D (with active HDV infection confirmed by a recent blood test) - You have compensated liver disease (not severely damaged liver) - You are currently on antiviral treatment for hepatitis B - You have just started (within 30 days) a 2 mg prescription of bulevirtide - You are of Caucasian ethnicity and follow a standard varied diet **You may NOT be eligible if...** - You have decompensated liver cirrhosis (severe liver failure) - You are not infected with both hepatitis B and D - You are pregnant or breastfeeding - You have a life-limiting illness such as cancer or heart failure - You have taken antibiotics, probiotics, or prebiotics in the month before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD

Roma, Italy

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NCT07429864

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