HERACLIS_BLV_D: Adherence to Real-Life Therapy With Bulevirtide in Chronic Hepatitis D.

Authors

Dimitra Lakiotaki, Margarita Papatheodoridi, Vasilios Sevastianos, Kalliopi Zachou, Dimitrios Christodoulou, John Koskinas, Melanie Deutsch, Alexandra Alexopoulou, Ioannis Elefsiniotis, Christos Triantos, Elena Gigi, Theodoros Androutsakos, Dimitrios S Karagiannakis, Iliana Mani, Dimitrios Dimitroulopoulos, Maria Mela, Emmanouil Sinakos, Spyros Michopoulos, Konstantinos Mimidis, Nikolaos Papadopoulos, Athanasios Kontos, Christos Veretanos, Dimitrios Lymperopoulos, George Giannoulis, Vasilios Papadimitropoulos, Evdoxia Avramopoulou, Alkistis Papatheodoridi, Spyridon Pantzios, Larisa Vasilieva, Hariklia Kranidioti, Emmanouil Koullias, Athanasios Soukovelos, Paraskevi Fytili, John Vlachogiannakos, Evangelos Cholongitas, Spilios Manolakopoulos, Ioannis Goulis, George Dalekos, George Papatheodoridis

Published in

Journal of viral hepatitis. Volume 33. Issue 7. Pages e70201.

Abstract

Daily subcutaneous bulevirtide (BLV) 2 mg has been approved as first-line treatment for chronic hepatitis D (CHD), but long-term real-world adherence data are limited. We assessed adherence rates during BLV therapy and their impact on treatment response. HERACLIS_BLV_D study (NCT05928000) included adult CHD patients initiating BLV 2 mg/day and followed in routine clinical practice. Virological response (VR) was defined as HDV RNA < 57.5 IU/mL or decline > 2 log₁₀ and biochemical response (BR) as normal ALT (≤ 40 IU/L). Adherence was evaluated through the national prescription system based on executed monthly BLV prescriptions. Treatment discontinuation was defined as no executed BLV prescription for > 3 months at the end of follow-up. Seventy-six patients were included. VR/BR rates were 73%/71% at 12 and 93%/74% at 24 months. Thirteen (17%) patients discontinued BLV (none due to adverse events); 6%-7% per year. Mean adherence among treated patients was 98% ± 6% in 1st year declining to 93% ± 13% in 2nd and 91% ± 17% in 3rd year (p ≤ 0.010). No baseline characteristic was associated with poor (< 90%) or good (≥ 90%) adherence to BLV therapy. Patients with poor vs. good adherence had lower VR rates (1st year: 33% vs. 77%, p = 0.038; 2nd year: 60% vs. 97%, p = 0.030). In conclusion, in clinical practice, < 10% of CHD patients discontinue BLV therapy annually. Adherence is excellent in the first year and remains > 90% until the third year although gradually declines. Poor (< 90%) adherence cannot be predicted but adversely affects the VR rates emphasizing the need for strategies to support long-term treatment retention.

PMID:
42322023
Bibliographic data and abstract were imported from PubMed on 20 Jun 2026.

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