FDA approves first hepatitis B functional cure

The U.S. Food and Drug Administration has approved GSK's new hepatitis B drug, Hibsago (bepirovirsen). The drug is the first treatment that can give patients a functional cure after a six‑month course of injections. It can allow people to stop daily antiviral medication, a lifelong requirement for most chronic hepatitis B sufferers. The approval came under the FDA's Breakthrough Therapy Designation, highlighting its potential to improve on current care.

Trial results and cure rates

In two Phase III trials, 19 % of patients met the criteria for a functional cure, meaning their viral DNA and the hepatitis B surface antigen were undetectable 24 weeks after stopping all treatment. By comparison, only about 1 % of patients on standard care achieved that result after 12 months. The trials also showed that 24 % of participants could discontinue existing medicine, a group that did not include any placebo recipients.

The drug works by targeting the virus's DNA, reducing the amount of viral particles and the antigen that signals infection. Patients who achieve a functional cure no longer need ongoing medication, lowering the risk of liver damage and cancer over time. GSK says that the injection can be self‑administered after the first dose, making the treatment more convenient for patients.

Chronic hepatitis B affects more than 250 million people worldwide and is responsible for about 56 % of liver cancers. Vaccination exists but uptake is uneven, and many people remain untreated or undiagnosed. A new functional cure could have a major public health impact, especially in regions where screening and vaccination are limited.

The approval was reported by STAT News, which highlighted GSK's development and the drug's significance for hepatitis B treatment.