- In September 2023, Hepcludex (bulevirtide)—developed by Gilead Sciences—received full European Medicines Agency (EMA) approval as the first-in-class entry inhibitor for chronic HDV infection. This development marked a pivotal moment for HDV treatment across Europe, as the therapy demonstrated significant improvements in viral suppression and liver enzyme normalization. The full approval reinforces its role as a central treatment option and reflects growing regulatory and clinical support for HDV-targeted therapeutics
- In June 2023, the European Association for the Study of the Liver (EASL) updated its clinical practice guidelines to include broader HDV screening recommendations for all HBsAg-positive individuals. This shift in clinical policy underscores a continent-wide push for early detection, aligning with WHO’s viral hepatitis elimination goals and driving demand for advanced diagnostics and antiviral therapies
- In May 2023, Italy’s Ministry of Health launched a nationwide hepatitis awareness and screening campaign, emphasizing HDV testing among high-risk populations such as migrants, people who inject drugs (PWID), and incarcerated individuals. This public health initiative significantly expanded the reach of diagnostic services and bolstered the early identification of co-infected patients, promoting timely clinical intervention
- In April 2023, Germany’s Robert Koch Institute published new epidemiological data highlighting a gradual increase in HDV testing across healthcare centers. The findings, coupled with state-sponsored digital tracking systems for hepatitis cases, are improving real-time surveillance and enhancing the responsiveness of national healthcare systems in addressing HDV burden
- In February 2023, INSERM (France’s National Institute of Health and Medical Research) initiated a multi-center clinical study assessing the long-term effectiveness of novel combination therapies for HDV. The study involves academic hospitals across France, Germany, and Spain, and represents a significant step forward in evidence generation for next-generation HDV treatments, strengthening Europe’s leadership in liver disease research
