5 Key Takeaways

• 1

  The FDA approved bepirovirsen as the first antisense oligonucleotide therapy for chronic hepatitis B in eligible adults without cirrhosis.

• 2

  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.

• 3

  Bepirovirsen is given by subcutaneous injection alongside existing antiviral therapy for up to 24 weeks and targets HBV RNA to reduce viral protein production.

• 4

  In pooled phase 3 trial results, functional cure occurred in 19% of bepirovirsen recipients and 0% of placebo recipients after treatment discontinuation.

• 5

  Bepirovirsen carries boxed warnings for serious liver reactions and low platelet counts, including potentially life-threatening bleeding.