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Experimental hepatitis B drug might offer ‘functional cure’ for a subset of patients
The six-month shot regimen beat dummy treatment, and analysts said a 15% to 20% response could support broad adoption.
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.