Experimental hepatitis B drug might offer ‘functional cure’ for a subset of patients
- On Thursday, researchers reported that an experimental hepatitis B drug, bepirovirsen, achieved a "functional cure" in about 20% of patients, allowing them to stop treatment without viral rebound.
- Chronic hepatitis B affects more than 250 million people worldwide and kills about 1.1 million annually because the virus hides in the body, ready to rebound when standard lifelong therapy stops.
- The trials included 1,838 participants who received weekly bepi injections for six months; GSK vice president Melanie Paff said the drug suppresses viral replication by binding to genetic components and stimulating the immune system.
- Dr. Seng Gee Lim of the National University Health System of Singapore called the results unprecedented, while Dr. Anna Lok of the University of Michigan wrote the findings "represent a major step" in treatment.
- The U.S. Food and Drug Administration is conducting fast-track review with a decision expected in October, while regulators in Japan, China, and Europe are also considering the drug.
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Tune Therapeutics Presents Positive Phase 1b/2a Proof of Concept Data on TUNE-401: a First-in-Class Epigenetic Silencer for Patients with Hepatitis B at EASL 2026
DURHAM, N.C. & SEATTLE--(BUSINESS WIRE)--May 30, 2026-
One in five patients achieve functional hepatitis B cure after 24 weeks of bepirovirsen
In an editorial published in the New England Journal of Medicine, University of Michigan Health hepatologist Anna S. Lok, M.D., hails newly announced results of the B-Well clinical trials as "a major step toward a functional cure for hepatitis B virus infection."
First-in-Class Hepatitis B Drug Shows Promise for 'Functional Cure' in Early Trials
An experimental new treatment for chronic hepatitis B is raising hopes for what researchers call a potential "functional cure," a milestone that could change how the viral liver disease is managed in the future.
New drug is a potential cure for the chronic hepatitis B, scientists say
Bepirovirsen, a hepatitis B drug awaiting FDA approval, shows the promise of being a functional cure, scientists say. The drug made the hepatitis B virus undetectable within 48 weeks in 20% of patients during a pair of clinical trials.
Hepatitis B drug may offer 'functional cure' for some patients
Researchers reported Thursday that in two international studies, about 1 in 5 patients given the experimental drug for six months saw their virus reduced to levels low enough that the immune system could keep it in check.
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