From Diagnosis to Durability: A Review of the European Bulevirtide Experience and Practical Learnings for CHD Management

ABSTRACT

Hepatitis delta virus (HDV) infection causes chronic hepatitis D (CHD), the most severe form of chronic viral hepatitis with a high risk of progression to advanced liver disease. Off‐label pegylated interferon alpha was the primary treatment option in Europe prior to the introduction of bulevirtide, a first‐in‐class HDV entry inhibitor. This review aimed to describe practical learnings around the management of CHD and strategies for supporting patients since bulevirtide 2 mg became the first approved treatment option in Europe. Since bulevirtide's approval, there has been an increased urgency to connect patients to care and real‐world evidence has accumulated, underscoring the importance of reflex testing, increased awareness of HDV among doctors, and harmonization of universal screening guidelines in Europe to facilitate care for patients early in the disease course. Discussions with patients have shifted from preparing for disease progression to living with a long‐term, daily treatment regimen, and clinical experience provides insight into best practices for navigating these conversations; it is critical for doctors to set evidence‐based treatment expectations and provide ongoing guidance and support to patients. Real‐world evidence demonstrates high treatment adherence and persistence; these studies and clinical trial data also indicate that long‐term bulevirtide monotherapy is safe and effective, even in patients with compensated cirrhosis, may improve liver fibrosis measurements, and potentially reduce the risk of liver‐related events and decompensation, which are important motivators for patients. Future research is needed to establish the safety and effectiveness of bulevirtide in certain special populations and determine the optimal treatment duration.