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

Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine

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 () included adult CHD patients initiating BLV 2 mg/day and followed in routine clinical practice. Virological response (VR) was defined as HDV RNA 2 logand 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 (≤ 0.010). No baseline characteristic was associated with poor ( 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.