At the start of January, pharmaceutical company GSK announced positive results from its two phase-III trials for bepirovirsen, a potential first-in-class treatment for chronic hepatitis B. They claim that bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate for HBV, which would be a dramatic development.
At the moment the available treatments for hepatitis B often require lifelong therapy and the functional cure rates remain low, with only a few percent of patients reaching this point.
Functional cure for chronic hepatitis B is defined as being when the virus can no longer be detected in the blood, as measured by the sustained loss of hepatitis B surface antigen (a viral protein that signals ongoing infection) and undetectable hepatitis B virus DNA for at least 24 weeks after a finite course of treatment finishes.
This allows the immune system to control the infection without further medication. Functional cure is associated with significant reduction in the risk of long-term liver complications, including liver cancer, as well as other associated health problems.
According to GSK, the functional cure was achieved in over 1,800 patients from 29 countries. Chief Scientific Officer Tony Wood said, “Today’s result supports our plans to progress bepirovirsen as a treatment and also continue its development as a backbone in future sequential therapies. We’re pleased by this major advance in our expanding hepatology pipeline, aimed to transform outcomes in liver disease.”
…bepirovirsen has the potential to become the first finite, six-month therapeutic option for CHB [chronic hepatitis B] …
It’s important to note that at this stage GSK has not yet published the full trial data for peer review, though they have announced that they plan to do so soon. The information that has been released is primarily aimed at investors, to get them excited about investing in the company.
Science senior correspondent Jon Cohen interviewed several independent researchers about the announcement. “This is a clear sign that a functional cure is realistic,” said epidemiologist Nick Walsh, who specializes in hepatitis diseases and was not involved in the studies.
Hepatologist Robert Gish said that it was encouraging, but stressed that we do not yet have access to the data. “GSK talked about statistically significant improvement, and that is fantastic that they met that endpoint, but we need to know more data to talk about whether it’s clinically significant,” he said.
GSK said on their website that, “Full results will be submitted for presentation at an upcoming scientific congress, published in a peer-reviewed journal and used to support regulatory submissions to health authorities worldwide.
“If approved, bepirovirsen has the potential to become the first finite, six-month therapeutic option for CHB and to serve as a backbone for future sequential treatment strategies.”
Read more
- https://www.science.org/content/article/new-hepatitis-b-drug-could-help-functionally-cure-some-patients
- https://www.clinicaltrialsarena.com/news/gsk-to-file-for-approval-of-twice-yearly-hep-b-drug-on-positive-phase-iii-data
Last updated 20 January 2026
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