Phase 3 results for hepatitis B treatment show functional cure for 1 in 5 people

Phase 3 results for hepatitis B treatment show functional cure for 1 in 5 people

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Phase 3 trials suggest bepirovirsen can achieve a functional cure in about one in five people with hepatitis B. Image credit: Getty Images / Liliya Krueger
  • In two phase 3 clinical trials, roughly one in five adults with chronic hepatitis B achieved sustained loss of hepatitis B surface antigen (HBsAg) and undetectable hepatitis B viral DNA after completing a finite course of bepirovirsen treatment.
  • Bepirovirsen reduces HBsAg production, aiming to restore the immune system’s ability to control the infection rather than simply suppressing viral replication.
  • Participants with lower baseline HBsAg levels experienced higher functional cure rates, suggesting patient selection may play an important role in treatment success.
  • While the results represent promising steps toward a functional cure for chronic hepatitis B, further research is necessary to improve response rates, evaluate long-term durability, and determine how the therapy performs in broader patient populations.

Chronic hepatitis B is a viral infection that affects the liver and remains a major global health challenge. Estimates suggest that roughly 250 million people are living with chronic hepatitis B, which predisposes them to develop severe complications, such as cirrhosis, liver failure, and liver cancer.

Current first-line treatment will typically involve antiviral therapy to suppress viral replication. However, these drugs rarely eliminate hepatitis B surface antigen (HBsAg), which is a key marker of persistent infection. Thus, many individuals may need to continue treatment indefinitely.

As a result, researchers have increasingly focused on therapies capable of achieving a functional cure, defined as sustained loss of HBsAg and undetectable HBV DNA after treatment has ended.

Now, results from two large phase 3 clinical trials indicate that the investigational drug bepirovirsen could mark a significant step toward a functional cure for chronic hepatitis B, offering hope beyond lifelong antiviral treatment for some patients.

The findings, published in the New England Journal of Medicine, showed that approximately 20% of eligible patients achieved a sustained functional cure after completing a finite course of treatment, an outcome not observed in those receiving a placebo.

Team Health Accessible
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Team Health Accessible

Health & Wellness Editorial Team

HealthAccessible editorial team delivers trusted, accessible, and evidence-based health information for everyone.

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