Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Gut Microbiota in HBV-HDV Patients on Bulevirtide
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Gut Microbiota in HBV-HDV Patients on Bulevirtide
Time Frame: 2-18 months
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.
Bile Acids in HBV-HDV Patients on Bulevirtide
Time Frame: 2-18 months
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.
Inflammation in HBV-HDV Patients on Bulevirtide
Time Frame: 2-18 months
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.
Secondary Outcomes
- Patient Characteristics and Treatment Response in HBV-HDV Cirrhosis(2-18 months)
- Correlation of Microbiota and Bile Acids with HBV-HDV Treatment Response(2-24 months)
Investigators
Ponziani Francesca Romana
Medical Director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS