Study of Changes in Bile Acid Profile and Gut Microbiota in Adults Treated with Bulevirtide for Hepatitis Delta Virus Infection

What this Trial Is About

Researchers are investigating the changes in bile acid profiles and gut microbiota in patients with Hepatitis Delta Virus HDV infection who are undergoing treatment with Bulevirtide. HDV affects individuals only in the presence of Hepatitis B Virus HBV and is associated with increased risks of liver cirrhosis, severe hepatitis, and liver cancer, especially in high-risk groups such as those with HIV, HCV, drug use, or dialysis. The study considers how the gut microbiota and bile acids influence liver fibrosis and cirrhosis progression, noting that dysbiosis seen in cirrhotic patients alters bile acid metabolism and increases liver toxicity. This observational study focuses on patients with chronic HDV-related hepatitis or compensated liver cirrhosis who are starting Bulevirtide therapy. Participants will be monitored over periods ranging from 2 to 24 months to evaluate their gut microbiota, bile acid levels, and inflammation. The study also examines patient characteristics and treatment responses, with special attention to correlations between microbiota, bile acids, and therapeutic outcomes. Participants will undergo assessments including measurements of gut microbiota and bile acids at different time points during treatment. Inflammation markers and patient responses will also be tracked throughout the study duration. The research team will monitor these factors to understand how Bulevirtide influences liver health and disease progression in HBV-HDV coinfected patients. The total participation time varies, with some outcomes measured up to 24 months from treatment start.

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