Hibsago (Bepirovirsen) for Hepatitis B: Results, Eligibility & Safety

Hibsago (bepirovirsen), from GSK, is an injectable treatment for chronic hepatitis B designed to achieve a functional cure after a fixed 24-week course. This video explains how it works, the phase 3 results, who is eligible, dosing and safety. Key facts • Approvals: Japan (August 2026) and US FDA (20 October 2026). Other regulators are still reviewing it. • How it is given: injections under the skin for 24 weeks, together with the usual hepatitis B tablets (nucleos(t)ide analogues such as tenofovir or entecavir). The first dose is given in the clinic; later doses can be self-injected after training. • Results (B-Well 1 and 2 trials, 1,834 adults, 29 countries): functional cure in 19% vs 0% with placebo, and 26% when baseline HBsAg was 1,000 IU/mL or lower. • Functional cure means HBsAg is undetectable and HBV DNA is below the test limit 24 weeks after stopping all hepatitis B treatment. • US eligibility: adults without cirrhosis, on hepatitis B tablets for at least 6 months with suppressed HBV DNA, and HBsAg 3,000 IU/mL or lower on an FDA-authorised test. • Not used in cirrhosis or with a platelet count below 100 x10⁹/L. Not recommended with hepatitis D. • Safety: boxed warning for liver enzyme flares during treatment and for low platelets. Kidney function (eGFR) can fall during treatment, usually recovering afterwards. Immune reactions and injection-site reactions can occur. Liver tests, platelets and kidney function are checked before, during and after treatment. • After the course, tablets continue for at least 24 more weeks. Stopping them is considered only if strict criteria are met, with close monitoring. Chapters 0:00 Introduction 0:33 The challenge: chronic hepatitis B 2:05 New drug: Hibsago 3:01 Trial results 4:15 Dosing and eligibility 5:29 Limits and safety 6:45 Are we closer to eliminating the daily pill? As of October 2026, Hibsago is approved only in Japan and the US. For education only; this is not medical advice. Do not stop your hepatitis B tablets without your doctor's advice, as stopping can cause a severe flare. Sources: US Prescribing Information for Hibsago (October 2026); GSK press release, 20 October 2026; Hou J et al., N Engl J Med 2026. #HepatitisB #Hibsago #Bepirovirsen #LiverHealth #HBV