FDA
FDA clears first treatment for hepatitis D infection
Image courtesy of Gilead
Chronic hepatitis delta virus (HDV) infection is considered the most severe form of viral hepatitis and can rapidly progress to cirrhosis, liver failure, and liver cancer. Until now, patients in the US had no FDA-approved treatment options.
On May 22, 2026, FDA granted accelerated approval to Hepcludex (bulevirtide-gmod), making it the first approved treatment for adults with chronic HDV infection who don’t have cirrhosis or who have compensated cirrhosis. The once-daily injectable therapy is designed to block HDV and hepatitis B virus (HBV) entry into liver cells.
“Today’s approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” said Wendy Carter, DO, Acting Director of the FDA Office of Infectious Diseases. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.”
Approval was based on findings from the phase 3 MYR301 trial, a multicenter, randomized, open-label study evaluating bulevirtide 8.5 mg daily. Patients assigned to immediate treatment were compared with a delayed-treatment group that underwent 48 weeks of observation before starting therapy.
At week 48, 48% of patients receiving bulevirtide achieved the trial’s combined primary endpoint — defined as either undetectable HDV RNA or at least a 2-log decline in viral load plus normalization of ALT levels — versus 2% in the delayed-treatment arm. Rates of undetectable HDV RNA increased over time, reaching 36% at week 96 and 50% at week 144.
FDA granted bulevirtide Breakthrough Therapy and Orphan Drug designations, along with priority review under the accelerated approval pathway. Common adverse effects included injection-site reactions, headache, abdominal pain, fatigue, and pruritus. The prescribing information also carries a boxed warning about severe exacerbations of HDV or HBV after treatment discontinuation.
Sources:
U.S. Food and Drug Administration. (May 22, 2026) FDA approves first treatment for chronic hepatitis delta virus (HDV) infection
Gilead Sciences. (May 22, 2026) FDA grants accelerated approval to Gilead’s Hepcludex (bulevirtide-gmod), the first and only approved treatment for chronic hepatitis delta virus (HDV)