Evaluate Response to Treatment Both Biochemically and Virologically to Determine the Safety and Effectiveness of Bulevirtide Therapy in HDV Patients
Conditions
Brief summary
1. The study is non-interventional, multicenter, non-profit 2. The primary objective of the study is to evaluate the safety and efficacy in clinical practice of the drug Bulevirtide in the treatment of patients with chronic HDV hepatitis. The drug is already approved and indicated in the treatment of patients with the aforementioned infectious pathology. 3. The Coordinating Center and the Principal Investigator of the study in question will be, respectively, the Department of Medical Health Sciences V. Tiberio and the undersigned Prof. Luca Rinaldi in cooperation with the Azienda dei Colli, Cotugno Hospital in Naples, Dr Antonio Izzi. 4. As regards the further economic aspects, it is underlined that no compensation of any kind is foreseen for the subjects participating in the study and that there are no expenses borne by the subjects participating in the study. The study will be coordinated, managed and analyzed independently.
Interventions
DIAGNOSTIC_TESTvirological tests diagnostic tests
The parameters collected will include blood sugar, HbA1c, complete blood count, lipid profile (total cholesterol, LDL, HDL, triglycerides), liver profile (ALT, AST, total and fractionated bilirubin, alkaline phosphatase, GGT) and renal profile (creatinine, azotemia), electrophoretic protein picture. Additionally, specific data for HDV and HBV infection will be collected, including HBsAg, anti-HBs, anti-HBc, HBV-DNA, and HDV-RNA. The glomerular filtration rate shall be calculated using the formula CKD-EPI. • Instrumental Tests: Results of abdominal ultrasounds, Fibroscan®/CAP for the evaluation of liver fibrosis
Sponsors
University of Molise
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with HDV and HBV-related liver disease considered suitable for antiviral or immunomodulatory treatment. * Absence of contraindications to the use of Bulevirtide * Age over 18 years. * Patients born to therapy or already undergoing cycles of therapy with standard interferon or pegylated. * Informed consent to study participation
Exclusion criteria
* Specific contraindications to bulevirtide • Presence of decompensated liver disease or other conditions that may interfere with study participation or interpretation of results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of bulevirtide | 12 months | Evaluate the virological response to treatment with bulevirtide, measured as reduction or clearance of serum or plasma HDV-RNA, after 12 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance and Adherence to Therapy | 12 months | Monitor patients' adherence to the bulevirtide treatment regimen, evaluating continuity of treatment and compliance with the prescribed dosage. This includes analysis of any interruptions or changes to treatment and the underlying reasons |
Countries
Italy
Outcome results
None listed