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· Hepatitis B · GSK · FDA approval · ASO
Could hep B treatment end? FDA approves GSK's bepirovirsen
After a six-month course, 1 in 5 patients kept the virus undetectable off all drugs. The first antisense (ASO) drug for chronic hepatitis B is now approved in the US.
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- 1. Could hep B treatment end? After a six-month course, 1 in 5 patients kept the virus undetectable off all drugs FDA approval · October 20, 2026
- 2. What just happened? GSK · Oct 20, 2026 The FDA approved GSK's bepirovirsen (Hibsago) for chronic hepatitis B. The first antisense (ASO) drug for hepatitis B One shot a week for six months For adults without cirrhosis and with low viral levels
- 3. From pills for life to a finite course New option 6-month injection 24 wks Some patients could stop every hepatitis B drug afterwards. Today Daily antiviral pills Lifelong They keep the virus down, but most people never stop.
- 4. 19% functionally cured, off all drugs 19% Virus still undetectable six months after stopping all treatment: 233 of 1,220 PLACEBO0 of LOW-HBsAg GROUP26% cured CURRENT CAREUnder 1% after 1 year Source: GSK · pooled phase 3 B-Well 1 & 2 (Oct 20, 2026)
- 5. Why it matters worldwide Patients 240M+ live with chronic hep Bmost on antivirals for life today Regulators Japan first, now the USEU and China decisions to follow Careers A test picks who gets the drugdiagnostics and medical affairs gain weight
- 6. 4 things to watch WATCH 01 Safety Boxed warnings on liver flares and low platelets. How will it go in clinics? WATCH 02 Durability How long does the effect last once drugs stop? WATCH 03 Next markets When will Europe and China decide? WATCH 04 RNA drugs Will more RNA medicines take on infections?
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