Hibsago receives approval in Japan as the first and only functional cure for chronic hepatitis B

GSK has recently announced that Japan’s Ministry of Health, Labour and Welfare has approved Hibsago (bepirovirsen), an antisense oligonucleotide, as a functional cure for chronic hepatitis B virus infection in adult patients who have completed at least six months of prior nucleos(t)ide analogue therapy and meet specific pre-defined viral markers. This represents the first approval worldwide for bepirovirsen, and it becomes the first and only functional cure treatment for chronic hepatitis B available in Japan.

Chronic hepatitis B remains a significant public health concern and one of the leading causes of liver cancer globally. In Japan alone, nearly one million people are living with the condition, which contributes to roughly 4,000 deaths each year. The Japanese government has shown strong commitment to addressing the disease, including through nationwide screening and treatment initiatives.

Tony Wood, chief scientific officer at GSK, said that for the first time, people living with chronic hepatitis B in Japan have access to a treatment approved specifically for functional cure. He said that after six months of treatment with Hibsago, patients could potentially be freed from lifelong therapy and face a reduced risk of long-term liver complications. He described the approval as a major step forward for chronic hepatitis B management and for GSK’s broader hepatology portfolio, adding that the company looks forward to regulatory decisions in additional countries.

The Japanese approval was supported by results from the Phase III B-Well trials, which showed functional cure rates of 19 percent among adults with baseline HBsAg levels of 3000 IU/ml or below, an unprecedented outcome compared with current standard of care alone, which typically achieves only a 1 percent functional cure rate after a year of treatment. Functional cure is defined as undetectable hepatitis B virus DNA and undetectable HBsAg viral protein for at least 24 weeks after all treatment has stopped, indicating the immune system has brought the disease under control without ongoing medication. Loss of HBsAg has been linked to as much as an 89 percent reduction in the risk of liver cancer and a 62 percent reduction in the risk of death from any cause.

The approval process was sped up through SENKU designation, a status granted to innovative medicines with the potential to meet significant unmet medical needs.

GSK continues to pursue regulatory submissions for bepirovirsen in multiple countries, with decisions expected in several markets, including the United States, over the coming months. Work is also ongoing to explore bepirovirsen’s use in future sequential treatment strategies.

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Related Topics and Keywords

chronic hepatitis b, hepatitis B, Hibsago