06/13/2026
FDA Approves Drug to Treat Chronic Hepatitis Delta Virus (HDV) Infection
The U.S. Food and Drug Administration (FDA) has approved the first treatment for adults with chronic hepatitis delta virus (HDV) infection without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide-gmod (Hepcludex) is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor administered as a subcutaneous injection.
The safety and efficacy of bulevirtide-gmod (Hepcludex) were evaluated in a multi-center, randomized, open-label, parallel-arm phase 3 trial. In Trial MYR301, participants were randomly assigned to immediate treatment with Hepcludex 8.5 mg once daily for 144 weeks or to delayed treatment with an observational period of 48 weeks followed by Hepcludex 8.5 mg once daily for 96 weeks. The primary efficacy endpoint was combined response, defined as undetectable HDV RNA (defined as less than the lower limit of quantification [LLOQ] [50 IU/mL] with target not detected) or ≥ 2 log10 IU/mL decline from baseline and aminotransferase (ALT) normalization, at week 48.
Warning and precautions for bulevirtide-gmod (Hepcludex) include a Boxed Warning for post-treatment severe acute exacerbation of hepatitis D and B. Discontinuation of Hepcludex may result in severe acute exacerbations of HDV and HBV infection, and monitoring should be conducted for 6 months after stopping treatment. The most common adverse reactions for bulevirtide-gmod (Hepcludex) include hypersensitivity reactions, injection site reactions, headache, abdominal pain, fatigue, and pruritus.
View the FDA’s announcement here:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-hepatitis-delta-virus-hdv-infection
