The FDA has approved GSK’s Hibsago (bepirovirsen), the first FDA-approved antisense oligonucleotide for chronic hepatitis B, as federal hepatitis B vaccination policy faces continued scrutiny.
The drug is approved in combination with existing antiviral therapy for certain adults without cirrhosis who have been taking HBV antiviral therapy for at least six months, have suppressed HBV levels and have HBsAg levels of 3,000 IU/mL or less, according to an Oct. 20 FDA release.
Across two clinical trials, 24% of patients who received Hibsago met requirements to stop their existing medicine, compared with none who received placebo. Twenty-four weeks after stopping all hepatitis B treatment, 19% of Hibsago patients still had the virus under control and had no detectable HBsAg.
The approval comes amid a fight over hepatitis B prevention. A new study published Oct. 20 in Annals of Internal Medicine modeled 3.6 million infants born in a year and projected that switching to vaccination at 2 months of age would raise chronic infections acquired by age 20 by 19%, to 303 cases a year from 255. Moving to shared decision-making for infants of mothers who test negative would raise cases 83%, to 467 a year, and leave more than half of children entering adulthood susceptible, the study found.
HHS Secretary Robert F. Kennedy Jr.’s vaccine advisers voted in December to end the universal birth-dose recommendation for infants of mothers who test negative, and the CDC adopted shared decision-making for those infants. Medical groups sued to block the changes, and a federal judge’s ruling restored the birth-dose recommendation in March. The administration has said it will appeal.
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