4CPS-148 Real-world use of bulevirtide: a retrospective study on quality of life, adherence, and safety in a cohort of adult patients with hepatitis delta virus

<h3>Background and Importance</h3> HDV is the smallest known hepatitis virus capable of infecting humans. Recent studies estimate the global prevalence of infection to be between 5% and 15%. Bulevirtide is the only anti-HDV drug currently approved in Europe and it requires complex self-management. Patients can benefit from a specific Patient Education programme to ensure better therapeutic compliance, optimal adherence, and continuous monitoring of the drug’s effectiveness and safety. <h3>Aim and Objectives</h3> To evaluate the effectiveness, safety, and adherence in a cohort of adult patients with hepatitis delta virus infection treated with bulevirtide at a University Hospital between July 2023 and September 2024. <h3>Material and Methods</h3> At the Hospital Pharmacy Unit, a Patient Education Programme (PEP) was developed for HDV patients. These patients received specific training from a clinical pharmacist on the preparation, administration, and storage of the drug, alongside monitoring for adherence, quality of life (QoL, through EuroQol-5D questionnaire), and adverse events. This observational study investigated: treatment effectiveness, in terms of QoL, by comparing the average values of Euro-QoL-5D at the first and last drug dispensing;. safety, through spontaneous adverse event reporting;. therapy adherence, measured by the Proportion of Days Covered (PDC). <h3>Results</h3> From July 2023, 31 patients (19 females and 12 males) started bulevirtide. The average age at the start of treatment was 55.9 ± 9.7 years. Since beginning the therapy, patients‘ QoL has increased significantly (+11.9%, p&lt;0.05), reaching 81.7/100. Twelve out of 31 patients (39%) reported at least one suspected adverse reaction: three reported injection site reactions, tiredness, and headache; two reported nausea, diarrhoea, abdominal pain, and dizziness; one reported myalgia, asthenia, weight loss, and blurred vision. Four patients discontinued the treatment. 93% of patients reached optimal adherence rates, with a PDC ≥90%. <h3>Conclusion and Relevance</h3> Bulevirtide treatment showed a significant improvement in patients’ QoL and a good safety profile: despite 39% reporting suspected adverse reactions, these were non-severe and mostly expected. Therapy adherence was optimal, partly due to the support of the dedicated PEP. Although four patients discontinued treatment, the results suggest that bulevirtide is an effective and well tolerated therapy. Long-term studies are needed to confirm these findings and to monitor the prolonged safety of the drug. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest