GSK’s Hibsago Secures FDA Approval for Potential Hepatitis B Functional Cure Treatment

Chronic hepatitis B infection is currently managed with antiviral drugs that patients must take long-term, perhaps for life. The FDA has approved a new GSK drug that offers the potential for a six-month course of treatment and then nothing more.

The drug works by reducing the virus to levels where the immune system can regain control and maintain the infection in check—a functional cure. The FDA’s approval adds a new product to GSK’s infectious disease portfolio, featuring a first-in-class approach expected to generate significant market interest.

While hepatitis B virus can cause acute infection, it becomes chronic when the immune system cannot clear the virus. Approximately 1.7 million people worldwide live with chronic hepatitis B infection, which is linked to increased liver cancer rates and mortality. Current standard treatment involves long-term antiviral therapy that either inhibits viral DNA or stimulates immune responses, though these approaches achieve low functional cure rates.

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