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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS20 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HBV HBV Coinfection HCV HIV Infections Hepatocellular Carcinoma Cirrhosis, Liver Fibrosis, Liver

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 2-18 months

Secondary Outcomes

Patient Characteristics and Treatment Response in HBV-HDV Cirrhosis

assess characteristics common to patients with chronic hepatitis or compensated liver cirrhosis HBV-HDV related to the first prescription of BLV 2 mg by examining their clinical and demographic history

Time frame: 2-18 months

Correlation of Microbiota and Bile Acids with HBV-HDV Treatment Response

To assess whether the composition of the intestinal microbiota (IM) and fecal bile acids (BA) is correlated with treatment efficacy at weeks 24, 48, and 96.

Time frame: 2-24 months

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts