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Bepirovirsen Achieves a Functional Cure in Up to 26% of Chronic Hepatitis B Patients

The U.S. Food and Drug Administration has authorized a new antisense oligonucleotide therapy that allows some patients to safely stop lifelong daily antiviral medication. The approval marks the first treatment regimen capable of achieving sustained viral clearance without continuous intervention.

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The FDA has authorized bepirovirsen as the first functional cure regimen for chronic hepatitis B.From: FDA Approves Bepirovirsen as First Functional Cure for Chronic Hepatitis B

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Key numbers

19%
Overall functional cure rate
26%
Cure rate in low-antigen subgroup
<5%
Cure rate with current standard of care
240M+
People globally with chronic HBV
89%
Reduction in liver cancer risk upon cure

From: Bepirovirsen Achieves a Functional Cure in Up to 26% of Chronic Hepatitis B Patients

Charts, maps and images

Bepirovirsen works by destroying viral RNA and allowing the patient's immune system to recognize the infection.From: FDA Approves Bepirovirsen as First Functional Cure for Chronic Hepatitis B ·
Up to 26 percent of patients on the optimal bepirovirsen regimen achieved a functional cure in clinical trials.From: FDA Approves Bepirovirsen as First Functional Cure for Chronic Hepatitis B ·
Phase 3 B-Well trial data demonstrates a significant leap in functional cure rates compared to the current standard of care.From: Bepirovirsen Achieves a Functional Cure in Up to 26% of Chronic Hepatitis B Patients ·
Achieving a functional cure through the loss of surface antigen drastically alters the long-term prognosis for patients.From: Bepirovirsen Achieves a Functional Cure in Up to 26% of Chronic Hepatitis B Patients ·
Illustration: The 24-week injection regimen requires close monitoring of liver function to safely manage immune system flares.From: FDA Approves Bepirovirsen as First Functional Cure for Chronic Hepatitis B ·
Antisense oligonucleotides work by binding to and degrading viral RNA, effectively starving the virus of the proteins it needs to replicate and evade the immune system.From: Bepirovirsen Achieves a Functional Cure in Up to 26% of Chronic Hepatitis B Patients ·

Timeline

October 2026

  1. FDA Approves Bepirovirsen as First Functional Cure for Chronic Hepatitis B

June 2026

  1. Bepirovirsen Achieves a Functional Cure in Up to 26% of Chronic Hepatitis B Patients