Dynamics of Virological and Clinical Response Parameters of Bulevirtide Treatment for Hepatitis D: Real-World Data

Abstract

Background and aimsThe entry inhibitor bulevirtide represents the first specific treatment for Hepatitis-D-virus (HDV)-infected patients. In clinical trials, around 80% of patients achieve normalization of alanine aminotransferase (ALT) with about 60% virological response after one year, but little is known about the dynamics of responses and clinical predictors of treatment outcomes. We report our single-center data from 15 patients and describe response dynamics, clinical outcomes and predictive factors for treatment response. MethodsRetrospective data from 15 patients have been analyzed at our department who started treatment with bulevirtide between 10/2020 and 08/2022. According to our standard procedures laboratory parameters were controlled monthly; transient elastography was performed every three months, treatment duration was twelve months. ResultsTreatment response rates after one year of treatment were similar to published data from clinical trials. ALT normalization usually occurs between month 2-6 of treatment, followed by a virological response after ≥ 6 months. Patients with more severe hepatitis at treatment start were less likely to respond in the first year of treatment. Loss of HDV-RNA was observed for one third of patients after ≥1 year of treatment. Low body-mass-index and high Alpha-fetoprotein at baseline were possible predictors of a delayed treatment response. ConclusionBulevirtide is a safe treatment option for HDV, leading to a fast hepatological response. Of note, decrease of transaminases precedes virological response. Patients with high viral load and ALT levels respond slower, but non-responders (as classified by Food and Drug administration criteria) still show reduction of viremia. Longer observation periods are required to determine the optimal duration of bulevirtide monotherapy.