First Hepatitis B Functional Cure Drug Gains FDA Approval

Buzzline

ScienceAlert reports that the US Food and Drug Administration approved bepirovirsen, sold as Hibsago by GSK, for chronic hepatitis B. GSK calls it the first functional cure, meaning the virus is suppressed to undetectable levels and stays controlled in responders after treatment ends. In two phase 3 trials published in the New England Journal of Medicine, a six-month course worked for 233 of 1,220 patients, or 19 percent, against none of 614 on placebo. Serious side effects included liver inflammation. Disclosure: This video contains stock footage and content created or enhanced using AI-assisted tools.

Transcript

00:00The FDA has approved the first drug that offers a functional cure for chronic hepatitis B.

00:05The drug is Beperovacin, sold as Hibsigo, from drugmaker GSK.

00:10Hepatitis B is a liver infection that can lead to cancer, scarring, or organ failure.

00:16It is linked to over a million deaths worldwide each year.

00:19A functional cure means the virus drops to undetectable levels in the blood.

00:24Existing treatments only keep the virus suppressed.

00:26In two Phase III trials, a six-month course worked for 233 of 1220 patients, or 19%.

00:34None of the 614 patients on a placebo responded.

00:38In those patients, the virus stayed undetectable for at least 24 weeks after treatment stopped.

00:44Some patients had serious side effects, including liver inflammation.

00:48It is not yet known whether the effect lasts for years.

00:51A liver specialist says it marks a new era for treating the infection.

00:55Disclosure. This video contains stock footage and content created or enhanced using AI-assisted tools.

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