The FDA has approved Gilead Sciences’ Hepcludex to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. The approval marks the first FDA-approved treatment for chronic HDV infection.
Hepcludex, also known as bulevirtide-gmod injection, was approved for patients with a serious liver disease that can lead to liver fibrosis, liver cancer, liver failure and death, according to a May 22 agency release. HDV is considered the most serious form of viral hepatitis and can accelerate the development of cirrhosis and liver cancer. Experts estimate roughly 80,000 Americans live with HDV — about 4% of people in the U.S. with hepatitis B, with whom co-infection is required.
The FDA granted the therapy Breakthrough Therapy Designation, Orphan-Drug Designation, priority review and approval under the Accelerated Approval pathway.
The approval was supported by results from the phase 3 MYR301 trial, which studied patients receiving Hepcludex 8.5 mg once daily. After 48 weeks, 48% of patients receiving the drug showed both lower levels of the virus and improved liver enzyme levels, compared with 2% of patients in the delayed treatment group.
At week 48, 20% of patients receiving Hepcludex had no detectable HDV virus in their blood, compared with 0% in the delayed treatment group. That rate increased to 36% at week 96 and 50% at week 144.
The FDA said possible side effects include hypersensitivity reactions, injection site reactions, headache, abdominal pain, fatigue and pruritus. The labeling includes a boxed warning that discontinuation may result in severe acute exacerbations of HDV and HBV infection.
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