A new drug for hepatitis B has shown promising results in clinical trials, offering a 'functional cure' for some patients. The experimental medication, bepirovirsen, enabled about one in five participants to stop all treatment without the virus returning. The findings were presented at a scientific meeting in Barcelona and published in the New England Journal of Medicine.
The drug, developed by GSK and Ionis Pharmaceuticals, targets hepatitis B by binding to its genetic material, suppressing viral replication and stimulating the immune system. In two international studies involving 1,838 patients, those receiving weekly injections of bepirovirsen for six months, alongside their regular medication, were able to stop all treatment if the virus remained undetectable for a further six months.
Researchers reported that approximately 20% of bepirovirsen recipients achieved this 'functional cure', with no patients in the placebo group reaching this endpoint. Dr. Seng Gee Lim of the National University Health System of Singapore, who co-led the studies, said: 'We have not had a treatment which has come to this level of cure.'
The U.S. Food and Drug Administration has granted fast-track review to bepirovirsen, with a decision expected in October. Regulatory bodies in Japan, China, and Europe are also evaluating the drug. Chronic hepatitis B affects over 250 million people worldwide and can lead to liver cancer or failure.
Experts caution that further research is needed to determine the long-term duration of the remission-like state. Side effects reported were generally mild, including injection-site reactions and temporary enzyme elevations. The trials did not include patients with cirrhosis or other complicating factors.
