GSK’s Bepirovirsen Moves Closer to Approval for Chronic Hepatitis B

GSK’s Bepirovirsen Moves Closer to Approval for Chronic Hepatitis B

By, Admin 30 March 2026

GSK plc has taken a key regulatory step as the European Medicines Agency (EMA) accepted its marketing authorisation application (MAA) for bepirovirsen, an investigational therapy for Chronic Hepatitis B (CHB).

If approved, bepirovirsen could reshape treatment by targeting one of the biggest unmet needs in hepatitis B: achieving a functional cure.

Why This Matters: A Disease with Limited Cure Options?

Chronic hepatitis B remains a major global and regional health burden:

Key Numbers

  • ~3.2 million people living with CHB in Europe
  • 250+ million patients globally
  • ~1.1 million deaths annually worldwide
  • ~56% of liver cancer cases linked to CHB

The Current Problem

Standard treatment, nucleos(t)ide analogues, comes with limitations:

  • Often requires lifelong therapy
  • Functional cure rates are extremely low (~1%)

What Is Functional Cure?

  • Undetectable HBV DNA
  • Loss of hepatitis B surface antigen (HBsAg)
  • Maintained for at least 24 weeks after stopping treatment

This is considered the ultimate treatment goal by global liver disease guidelines.

What Makes Bepirovirsen Different?

Bepirovirsen is an antisense oligonucleotide (ASO) designed to directly target the virus at the genetic level.

Triple Mechanism of Action

It works in three ways:

  • Destroys viral RNA (mRNA and pregenomic RNA)
  • Inhibits viral replication
  • Reduces HBsAg levels and boosts immune response

This approach aims to restore immune control, rather than just suppress the virus.

Phase III Data: Strong Results from B-Well Trials

The EMA submission is backed by two Phase III trials:

  • B-Well 1
  • B-Well 2

Trial Highlights

  • Both trials met their primary endpoints
  • Demonstrated statistically significant functional cure rates
  • Bepirovirsen + standard of care outperformed standard care alone

Additional Insights

  • Stronger effects seen in patients with:
    • HBsAg ≤1000 IU/ml
  • Consistent results across all key secondary endpoints
  • Acceptable safety and tolerability profile

The trials were:

  • Global, multi-centre (29 countries)
  • Randomised, double-blind, placebo-controlled

Strategic Potential: A Backbone Therapy

Beyond standalone use, GSK is positioning bepirovirsen as:

  • A foundation therapy
  • For combination or sequential treatment strategies

This could expand functional cure rates across broader patient populations.

Development Background

  • Licensed from Ionis Pharmaceuticals
  • Co-developed through collaboration
  • Not yet approved anywhere globally

Full data from the trials will be:

  • Presented at scientific congresses
  • Submitted for peer-reviewed publication in 2026

What Happens Next?

With the EMA now reviewing the application:

  • A regulatory decision will follow after evaluation
  • Approval could introduce one of the first curative-intent therapies for CHB

Final Take

Bepirovirsen represents a potential shift from viral suppression to functional cure.

If approved, it could:

  • Reduce reliance on lifelong therapy
  • Lower long-term complications like liver cancer
  • Redefine treatment goals in hepatitis B

The key question now: Will these functional cure rates hold up in real-world use?

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