FDA Approves First Treatment for Chronic Hepatitis Delta Virus (Hepcludex)

The U.S. Food and Drug Administration (FDA) has approved the injection Hepcludex (bulevirtide-gmod) for the treatment of chronic hepatitis delta virus (HDV) infection in adults who do not have cirrhosis or who have compensated cirrhosis. This approval establishes bulevirtide as the first FDA-approved therapy for HDV, a severe and potentially life-threatening disease that can progress rapidly to liver fibrosis, liver cancer, liver failure, and death.

HDV infection occurs only in individuals already infected with hepatitis B virus (HBV). Risk factors for HBV infection include unprotected sexual contact, injection drug use, and occupational exposure to infected blood. Vaccination against HBV also provides protection against HDV.

FDA authorizes first therapy for chronic hepatitis delta virus, Hepcludex, following clinical trial success and accelerated review pathway

The effectiveness of Hepcludex was demonstrated in the Phase 3 MYR301 clinical trial, a multicenter, randomized, open-label, parallel-arm study. Participants were assigned either to immediate treatment with 8.5 mg of Hepcludex once daily for 144 weeks or to delayed treatment consisting of a 48-week observation period followed by 96 weeks of daily 8.5 mg dosing.

The primary efficacy endpoint at week 48 was a combined response defined as either undetectable HDV RNA or a reduction of at least 2 log10 IU/mL from baseline, together with normalization of ALT levels. At week 48, the combined response rate was 48% in the immediate treatment group compared with 2% in the delayed treatment group.

At week 48, undetectable HDV RNA was observed in 20% of patients in the Hepcludex group, while none in the delayed group achieved this outcome. By weeks 96 and 144, the proportion of patients with undetectable HDV RNA increased to 36% and 50%, respectively, in the immediate treatment group.

Safety data show that Hepcludex may cause hypersensitivity reactions, including anaphylaxis, as well as injection site reactions, headache, abdominal pain, fatigue, and itching. The prescribing information includes a boxed warning stating that stopping treatment may result in severe acute worsening of both HDV and HBV infections.

The FDA granted bulevirtide breakthrough therapy and orphan drug designations. It also received priority review status and was approved through the FDA’s accelerated approval pathway. The approval was issued to Gilead Sciences.

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(Featured image by PublicDomainPictures via Pixabay)

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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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