Bulevirtide: A Novel Treatment for Chronic Hepatitis Delta Virus Infection

1. Bulevirtide Approval: Bulevirtide, a first-in-class entry inhibitor, was conditionally approved by the European Medicines Agency in 2020 for the treatment of compensated chronic HDV infection.
2. Clinical Trials: Phase II and III clinical trials have demonstrated the efficacy and safety of bulevirtide monotherapy in reducing HDV RNA levels and improving liver function.
3. Dosing and Duration: Studies have evaluated bulevirtide at doses of 2 mg and 10 mg, with treatment durations ranging from 24 weeks to 144 weeks.
4. Virological and Biochemical Responses: Bulevirtide has shown significant virological and biochemical responses, including undetectable HDV RNA and ALT normalization, in both clinical trials and real-world settings.
5. Safety Profile: Bulevirtide has been found to have an optimal safety profile, with minimal side effects and no signs of treatment resistance.
6. Combination Therapy: The potential benefits of combining bulevirtide with other antiviral agents, such as PegIFN, are being explored to enhance treatment outcomes.
7. Unmet Needs: Despite the progress made with bulevirtide, there are still significant unmet needs in HDV treatment, including the need for improved screening strategies, better understanding of HDV pathogenesis, and development of new biomarkers and treatments.