FDA Approves New Hepatitis B Treatment That May Replace Daily Antivirals

The US FDA approved Hibsago (bepirovirsen), a new injectable treatment for chronic hepatitis B, allowing certain patients to stop antiviral medication while maintaining viral control. The approval was announced Tuesday for adults without cirrhosis. Developed by GSK, Hibsago is the first FDA-approved antisense oligonucleotide for hepatitis B, interfering with viral reproduction. In clinical trials, 24% of recipients met criteria to stop antivirals, with 19% maintaining viral control 24 weeks later, compared to none in placebo groups. The medicine carries a boxed warning for serious liver reactions and reduced platelet counts, requiring regular monitoring. A companion diagnostic test by Roche was also authorized to identify eligible patients.