Assessment of Response and Safety of Bulevirtide Treatment in Patients With Chronic Delta Virus Infection

Assessment of Response and Impact on Safety, Adherece Anc Persistent During Treatment in an Observational Trial for the Evaluation of the Long-term Effectiveness of Bulevirtide in Patients With Chronic Delta Hepatitis: the ARISTOTELE Study

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.

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