US FDA approves bepirovirsen for chronic hepatitis B treatment — ScienceAlert

The US Food and Drug Administration (FDA) has approved bepirovirsen, marketed under the brand name Hibsago, for the treatment of chronic hepatitis B. The decision was made after two Phase 3 clinical trials, the results of which were published in the New England Journal of Medicine, ScienceAlert reports.

The drug was developed by the pharmaceutical company GSK. The company calls bepirovirsen the first treatment that may provide a so-called functional cure for chronic hepatitis B: the virus in the blood is suppressed to an undetectable level, and in some patients infection control persists after therapy is discontinued. At the same time, traces of the virus remain in the body, and the duration of this effect over many years has yet to be established.

Study results

A six-month course of bepirovirsen provided a functional cure in 233 of 1,220 participants, or 19%. No such outcome was recorded in the placebo group: 0 of 614 participants. In patients who responded to treatment, the virus remained undetectable for at least 24 weeks after all therapy was stopped — that is, 72 weeks after the start of the study.

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Bepirovirsen is administered through weekly injections alongside existing oral antiviral drugs. For patients who achieved the required outcome, these medications could also be discontinued. The likelihood of an effect was higher in people with lower initial levels of a key protein associated with chronic hepatitis B.

Adverse reactions and monitoring

The FDA warned of the need for regular blood tests during treatment. Some trial participants experienced serious adverse reactions, including liver inflammation. GSK and researchers also plan to study combinations of bepirovirsen with other drugs to increase the effectiveness of therapy.