FDA approves first-ever treatment for hepatitis delta, offering hope to 80,000 Americans
Doylestown, Pa., May 26, 2026 – The U.S. Food and Drug Administration (FDA) announced on May 22 that it has approved Gilead’s drug Hepcludex (bulevirtide), to treat chronic hepatitis delta in the U.S.
This is the first drug ever approved for hepatitis delta virus (HDV) and follows approvals in the European Union and United Kingdom. It is a major milestone for people in the U.S. living with hepatitis B/hepatitis delta co-infection. Experts estimate that about 4% of people living with hepatitis B in the U.S. also have hepatitis D, which is about 80,000 people.
HDV is the most serious form of viral hepatitis infection, which can accelerate the development of cirrhosis and liver cancer. Hepatitis delta can cause a significant reduction in quality of life for people living with the disease, along with serious negative clinical outcomes.
“Until now, there was very little that we could do to prevent cirrhosis and liver cancer for people living with hepatitis delta in the U.S.,” said Chari A. Cohen, DrPH, MPH, president of the Hepatitis B Foundation. “All of us at the Hepatitis B Foundation are optimistic that the FDA’s approval of Hepcludex will be a game changer, leading to improved HDV screening, diagnosis, care and treatment across the U.S.”
Chari A. Cohen, DrPH, MPH
Bulevirtide was developed by Stephan Urban, PhD, and his team at the Heidelberg University Hospital and the German Center for Infection Research (DZIF). Dr. Urban, a globally recognized virologist, was awarded the Hepatitis B Foundation’s Baruch S. Blumberg Prize, its highest honor, in 2023.
Hepcludex blocks a peptide that the virus uses to enter liver cells, thereby blocking entry into cells. Phase 3 clinical trial results showed that Hepcludex led to a reduction in hepatitis D RNA in the blood, as well as normalization of ALT. The drug is given as a once daily injection and has been FDA approved for people living with hepatitis delta who do not have cirrhosis, or who have compensated cirrhosis.
The Foundation will be ramping up efforts to help improve awareness, screening and linkage to care for hepatitis delta in the U.S. and will be creating opportunities for people to learn more about hepatitis delta and new treatment options.
About Hepatitis B and hepatitis D: Hepatitis B is the most common serious liver infection in the world. It is caused by the hepatitis B virus that attacks and injures the liver. Hepatitis delta (hepatitis D) is also a virus, and only those infected with hepatitis B can be infected with hepatitis delta. Hepatitis B/D co-infection can result in the most severe form of viral hepatitis. Each year up to 1 million people die from hepatitis B worldwide, even though it is preventable and treatable. Hepatitis B and D are a “silent epidemic” because most people do not have symptoms when they are newly or chronically infected. Thus, they can develop serious and end-stage liver disease or liver cancer without warning. A safe and effective vaccine prevents hepatitis B and D infection; and diagnosis, care and treatment prevent liver damage and save lives.
About the Hepatitis B Foundation: As the world’s leading hepatitis B advocacy and research organization, the Hepatitis B Foundation is one of the most active proponents of improving hepatitis B screening, prevention and treatment of the disease. We are the only nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. Founded in 1991, the Hepatitis B Foundation is based in Doylestown, Pa., with staff in Washington, D.C., and Philadelphia. To learn more, go to www.hepb.org, read our blog, follow us on LinkedIn, Twitter, Instagram and Facebook (@hepbfoundation) or contact us through info@hepb.org or 215-489-4900.