Hepatitis B Foundation welcomes approval of bepirovirsen, a new treatment option for chronic hepatitis B
Approval marks a milestone for the chronic hepatitis B community and renewed momentum for screening, diagnosis, and care
Doylestown, Pa. (Oct. 20, 2026) – The Hepatitis B Foundation today welcomes the approval of bepirovirsen (Hibsago) by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis B (CHB) in adults with CHB. This is the first approved drug that can lead to a functional cure in some people with CHB, and gives people living with CHB a new, innovative treatment option.
Bepirovirsen, developed by GlaxoSmithKline (GSK), is an antisense oligonucleotide (ASO) that demonstrated the potential to achieve a functional cure in 20% of patients who received the therapy in phase III clinical trials.
“CHB is a major public health challenge, affecting around 2.4 million people in the U.S. and accounting for approximately 56% of all global liver cancer cases,” said Dr. Chari Cohen, president of the Hepatitis B Foundation. “Today marks significant progress towards our aim of transforming the way CHB is managed. People living with CHB will benefit from the availability of innovative treatment options. Not only is this the first functional cure approved for hepatitis B,but it is also the first new therapy we have had approved in the U.S. in 10 years.”
Chronic hepatitis B can lead to serious complications, including cirrhosis, liver failure and liver cancer, yet many people living with the virus are unaware of their infection. The Foundation continues to urge universal hepatitis B screening and vaccination and to support timely linkage to care for people who test positive.
The Hepatitis B Foundation encourages people living with CHB to talk with their healthcare provider about what their treatment options are, and whether bepirovirsen may be appropriate for them. People who have not been tested for hepatitis B should ask their provider about screening. Resources for patients and providers are available at www.hepb.org.
About Hepatitis B: 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. Each year more than one million people die from hepatitis B worldwide, even though it is preventable and treatable. Hepatitis B is a “silent epidemic” because most people do not have symptoms when they are newly or chronically infected. Thus, they can unknowingly infect others and continue the spread of hepatitis B. For people who are chronically infected but don’t have any symptoms, their livers are still being silently damaged, which can develop into serious liver diseases such as cirrhosis or liver cancer.
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., New York,and Philadelphia. To learn more, go to www.hepb.org or contact us through info@hepb.org | 215-489-4900.
Contact: Monique Benvenutti
monique.benvenutti@hepb.org