Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HBV, HBV Coinfection, HCV, HIV Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
Overview
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.
Primary outcome measures
- Gut Microbiota in HBV-HDV Patients on Bulevirtide [Time frame: 2-18 months]
- Bile Acids in HBV-HDV Patients on Bulevirtide [Time frame: 2-18 months]
- Inflammation in HBV-HDV Patients on Bulevirtide [Time frame: 2-18 months]
Secondary outcome measures (2)
- Patient Characteristics and Treatment Response in HBV-HDV Cirrhosis [Time frame: 2-18 months]
- Correlation of Microbiota and Bile Acids with HBV-HDV Treatment Response [Time frame: 2-24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD — Roma
Identifiers
NCT: NCT07429864 · 7914