The FDA has approved GSK’s Hibsago for adults with chronic hepatitis B virus infection who meet specific virological criteria and have been receiving nucleos(t)ide analogue therapy for at least six months. The antisense oligonucleotide is the first treatment to show functional cure rates far exceeding the current standard of care.
Tony Wood said: “Despite current therapies, many people living with chronic hepatitis B remain on treatment indefinitely and continue to face the risk of serious liver complications.
“For the first time, with Hibsago, US patients have the potential to achieve functional cure after a six-month treatment course, with the added convenience of the option of self-administration after the first dose.”
The approval is based on phase 3 B‑Well trials, which showed functional cure rates of 19% in adults with baseline HBsAg levels ≤3000 IU/ml. Current standard of care typically achieves less than 1% functional cure after one year of treatment. Functional cure is defined as undetectable HBV DNA and HBsAg for at least 24 weeks after stopping all therapy.
Dr Norah Terrault said: “This is the start of a new era in treating people living with CHB. Bepirovirsen offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike.”
Dr Chari Cohen said: “CHB is a major public health challenge, affecting millions of people in the US and accounting for approximately 56% of all global liver cancer cases.
“Today marks significant progress towards our aim of transforming the way CHB is managed with improvements in screening, diagnosis and the availability of innovative treatment options for our community.”
Quantitative surface antigen testing will support identification of suitable patients, with several FDA‑authorised tests available. GSK is advancing regulatory submissions for bepirovirsen globally, with key decisions expected soon.
