FDA Approves Hepatitis B Drug That Helps Some Patients Stop Antivirals

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The US FDA approved Hibsago (bepirovirsen) on October 20, 2026, as the first antisense oligonucleotide treatment for chronic hepatitis B, enabling some patients to control the virus after stopping all antiviral medicines. The weekly injection, given for up to 24 weeks, targets viral RNA to reduce hepatitis B surface antigen. In Phase 3 trials across 29 countries, 19% of treated patients maintained viral control 24 weeks after stopping therapy, versus none on placebo. Approved for non-cirrhotic adults on antivirals, the drug carries warnings for liver reactions and low platelet count. Japan granted the first global approval in August 2026.


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FDA Approves Hepatitis B Drug That Helps Some Patients Stop Antivirals | News Minimalist