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A new era in hepatitis B care has arrived. The FDA approved Hibsago (bepirovirsen), the first antisense oligonucleotide therapy for chronic hepatitis B, offering eligible patients a shot at a "functional cure" — meaning the immune system controls the virus without ongoing medication. In clinical trials, 19% of treated patients remained virus-free six months after stopping all treatment, compared to zero in the placebo group.
A new era in hepatitis B care has arrived. The FDA has approved Hibsago (bepirovirsen, GSK) — the first antisense oligonucleotide therapy for chronic hepatitis B virus (HBV) — marking a significant shift in how the disease can be managed. Unlike standard daily antiviral pills that patients often take for years, Hibsago works by disrupting the genetic instructions the virus uses to replicate, and is administered as a subcutaneous injection for up to 24 weeks alongside existing antiviral therapy.
The drug is approved for adults without cirrhosis who have been on HBV antiviral therapy for at least 6 months, have suppressed viral levels, and have hepatitis B surface antigen (HBsAg) levels ≤3,000 IU/mL. After completing the injection course, patients who meet specific health and lab criteria may be able to stop all HBV treatment entirely — a long-sought goal in the field.
By the Numbers:
Why it matters: Chronic hepatitis B has long lacked a true cure, with most patients requiring lifelong antiviral therapy. Hibsago's approval — backed by FDA Priority Review, Fast Track, and Breakthrough Therapy Designation — offers a realistic path to functional cure for a meaningful subset of patients, potentially reducing long-term treatment burden and disease complications like cirrhosis and liver cancer. Its boxed warning for serious liver reactions and low platelet counts means close monitoring remains essential.
