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.
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
Decompensated liver cirrhosis (Child-Pugh Score B or C)
Patients without HBV-HDV-related infection/hepatitis/cirrhosis
Age ≤18 years
Pregnant or breastfeeding women
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.
Cohort
Prospective
Not listed
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.
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.
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.
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
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.
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