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Experimental hepatitis B drug may offer ‘functional cure’ for some patients

Experimental hepatitis B drug may offer ‘functional cure’ for some patients

Summary

A new experimental drug called bepirovirsen shows promise in providing a "functional cure" for some hepatitis B patients by reducing the virus to very low levels. In clinical trials, about 20% of patients given this drug were able to stop treatment without the virus returning, which is a first in hepatitis B care.

Key Facts

  • Hepatitis B is a liver infection that can become chronic and cause serious liver damage or cancer.
  • Current treatments require patients to take pills for life to keep the virus under control.
  • Bepirovirsen (nicknamed "bepi") is an experimental drug developed by GSK and Ionis Pharmaceuticals.
  • The drug works by blocking the virus’s genetic parts and a key surface protein, while also boosting the immune system.
  • Two large international studies involved 1,838 patients using weekly bepi shots along with regular pills for six months.
  • About 1 in 5 patients on bepi achieved a "functional cure," meaning the virus stayed undetectable for at least six months after stopping all treatment.
  • None of the patients who received placebo shots (dummy shots) reached this level of virus control.
  • The drug is under fast-track review by the U.S. FDA, with a decision expected in October, and regulators in Japan, China, and Europe are also considering it.
  • Early follow-up showed that most patients with a functional cure remain well for up to three years, but more research is needed to understand how long the effect lasts.
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