Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide

NCT07429864 | Recruiting

• 1 other identifier: 7914
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

gut microbiota; Bile Acids; dysbiosis

Outcome Measures

Primary Outcomes (3)

• Gut Microbiota in HBV-HDV Patients on Bulevirtide

  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.

  2-18 months

• Bile Acids in HBV-HDV Patients on Bulevirtide

  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.

  2-18 months

• Inflammation in HBV-HDV Patients on Bulevirtide

  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.

  2-18 months

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic hepatitis or compensated liver cirrhosis (Child-Pugh Score A) related to HBV-HDV, at the time of the first prescription of BLV 2 mg, will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

HIV Infections; Carcinoma, Hepatocellular; Liver Cirrhosis; Communicable Diseases; Dysbiosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Francesca Romana Ponziani

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Romana Ponziani

CONTACT

+390630159336; francescaromana.ponziani@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: February 24, 2026
• Study Start: September 24, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

IT (1)