Bile acid and gut bacteria changes in people with hepatitis D taking bulevirtide
Observes bile acids and gut bacteria in adults with hepatitis D treated with bulevirtide.
Plain-language title generated from the registry record
Registry title: Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMADRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07429864
- Record updated
- 24 February 2026
- Original description
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.Read full original descriptionShow less
Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
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.
Inclusion: 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: Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III/IV, COPD GOLD C-D); Patients without HBV-HDV-related infection/hepatitis/cirrhosis; Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition; Age ≤18 years; Decompensated liver cirrhosis (Child-Pugh Score B or C); Pregnant or breastfeeding women.