FDA approves first antisense therapy for hepatitis B

Bepirovirsen achieved sustained viral control after treatment discontinuation in 19% of patients across 2 phase 3 trials.

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The FDA approved bepirovirsen as the first antisense oligonucleotide therapy for chronic hepatitis B in eligible adults without cirrhosis.
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Eligible adults must have received nucleos(t)ide analogue therapy for at least 6 months, have suppressed HBV DNA, and have HBsAg levels of 3,000 IU/mL or less.
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Bepirovirsen is given by subcutaneous injection alongside existing antiviral therapy for up to 24 weeks and targets HBV RNA to reduce viral protein production.
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In pooled phase 3 trial results, functional cure occurred in 19% of bepirovirsen recipients and 0% of placebo recipients after treatment discontinuation.
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Bepirovirsen carries boxed warnings for serious liver reactions and low platelet counts, including potentially life-threatening bleeding.

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