Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
Recruiting
Observational Study
HBV
HBV Coinfection
HCV
HIV Infections
Hepatocellular Carcinoma
Cirrhosis, Liver
Fibrosis, Liver
Bile Acid Malabsorption
Microbial Colonization
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 20 (estimated)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Other
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About This Trial
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 entr…
Trial Locations
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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 da…
Contacts