New hepatitis B drug lets some patients stop all treatment
GSK's experimental drug bepirovirsen helped roughly 20% of patients in two trials achieve a functional cure, suppressing the virus even after stopping therapy. The FDA is expected to rule on approval by October.
May 28th 2026 · World
A first-of-its-kind drug for hepatitis B is offering some patients the possibility of stopping treatment without the virus returning, researchers reported Thursday. The experimental medication, bepirovirsen, developed by GSK and Ionis Pharmaceuticals, allowed approximately 20 percent of patients in two international studies to achieve a "functional cure," meaning the virus was suppressed to levels their immune systems could keep in check even after all treatment ended. No patients receiving placebo shots achieved this outcome. The findings were presented at a scientific meeting in Barcelona and published in the New England Journal of Medicine. The trials included 1,838 patients who received weekly injections of bepirovirsen or a placebo for six months while continuing their standard medication. If the virus remained undetectable for six months after stopping the injections, participants could discontinue their daily pills. The drug works by binding to hepatitis B's genetic components, suppressing viral replication and a key protein while also stimulating the immune system, according to GSK vice president Melanie Paff. Dr. Anna Lok, a hepatitis expert at the University of Michigan who was not involved in the research, called the findings "a major step," though she cautioned that more study is needed to determine how long the remission-like state persists. GSK has tracked patients from earlier-stage studies and found most remained well for up to three years. Chronic hepatitis B can cause liver cancer or liver failure and kills about 1.1 million people worldwide each year. The infection affects approximately 1.7 million people in the United States and more than 250 million globally. Current standard treatments are lifelong daily pills that reduce viral levels but cannot completely eliminate the virus due to its ability to hide in the body and rebound if therapy stops. Bepirovirsen is now under fast-track review by the U.S. Food and Drug Administration, with a decision expected in October, and regulators in Japan, China, and Europe are also evaluating the drug.