P128 Real world experience with Bulevirtide (Hepcludex ): results from UK multicentre evaluation

<h3>Introduction</h3> Bulevirtide (Hepcludex®) received UK conditional marketing authorisation in June 2023 as the first approved treatment for chronic hepatitis delta virus (HDV) infection in those with significant fibrosis who are non-responders or who have contraindications to pegylated interferon. Treatment approval is typically made through multidisciplinary team (MDT) discussions. Administered as a daily subcutaneous injection requiring refrigerated storage, bulevirtide can present with pharmaceutical management challenges. A multicentre evaluation across five UK centres assessed its efficacy, tolerability, and adherence. <h3>Methods</h3> All patients initiated on bulevirtide across 5 national centres from August 2023 to November 2024 were investigated. Data from dispensing records and patients’ notes were used to analyse patient demographics, treatment response, tolerability and adherence. <h3>Results</h3> A total of 47 patients were initiated on bulevirtide with monitoring primarily in nurse- and pharmacist-led clinics. 26% (12/47) were patient referrals from external centres. The average age was 46 years (±9.1) and 57% (27/47) had cirrhosis (METAVIR stage F4). 55% (26/47) were of white other/white European ethnicity with 38% (18/47) born in Romania. At week 24, 64% (30/47) achieved virological response (VR; ≥2 log¹⁰ IU/mL HDV RNA reduction), 17% (8/47) showed partial virological response (PVR; ≥1 to &lt;2 log¹⁰ IU/mL reduction), 51% (24/47) had ALT normalisation, and 36% (17/47) achieved combined response (CR; VR plus ALT normalisation). Therapy was continued in 98% (46/47) after MDT review. At the time of data collection, 35 patients had completed 48 weeks of bulevirtide treatment. Among them, 80% (28/35) had VR, 11% (4/35) PVR, 60% (21/35) ALT normalisation, and 57% achieved CR. Therapy was continued in 97% (34/35) after MDT review. Side effects were reported by 51% (24/47) (figure 1), with dizziness, nausea, arthralgia, and fatigue occurring more frequently than reported in the product licence (very common as opposed to common). No patients discontinued due to adverse effects. Dose omissions were reported by 21% (10/47) during clinic visits, usually 1–2 missed doses. 70% (7/10) of this group experienced side effects. Of the dose-missing group, 6 had CR, 2 had VR only, and 1 had ALT normalisation. <h3>Discussion</h3> While side effects were common, they were generally mild and did not result in treatment discontinuation. Some missed doses may have been side effect-related, yet did not appear to impact treatment outcomes. Ensuring multilingual patient education is vital in an ethnically diverse population. Nurses and pharmacists can play a key role in supporting adherence and managing the practical challenges with bulevirtide.