The U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen), a hepatitis B drug developed by the British pharmaceutical company GSK. The new medication allows patients with chronic infection to maintain control over the virus even after discontinuing treatment.
According to the agency, Hibsago is the first antisense oligonucleotide approved for the treatment of chronic hepatitis B. Clinical trial data demonstrate that nearly 20% of patients (one in five) achieved undetectable viral levels and maintained what medicine defines as a “functional cure” for at least six months without antiviral therapy.
More than 250 million people worldwide live with chronic hepatitis B. The condition causes severe liver damage and cirrhosis. Current standard-of-care treatments (nucleotide analogues) suppress the virus, yet help clear it completely in only 1–4% of patients. Consequently, most individuals must remain on medication for life.
The drug, in-licensed by GSK from Ionis Pharmaceuticals, is already approved in Japan and is currently awaiting regulatory authorization in Europe and China. Meanwhile, the American biotechnology firm Aligos Therapeutics is developing a rival therapy with a similar mechanism of action, which is currently in mid-stage clinical trials.
