Hi everyone, my name is Sarah, and I am a clinical trial manager at Storr Liver Centre. As you know, people with hepatitis B who are on antiviral treatment are usually recommended to stay on treatment for their entire life. We are running an observational study where we offer the option to people who have been on long-term treatment and have well suppressed hepatitis B virus (HBV) to stop medication with close monitoring, as per current guidelines.
Stopping medication can lead to strong activation of an effective immune response against HBV in the liver.
For some people (10-20%), this can lead to hepatitis B cure (HBsAg clearance) which (over the long term) significantly reduces liver inflammation, risk of cirrhosis and liver cancer. For others (~40%), the immune system can effectively control the virus and they can stay off treatment. But for the majority (50-70%), HBV replication starts again, and they need to restart treatment to reduce the risk of worsening liver disease.
While stopping treatment is an option within current guidelines, it is not widely practiced because doctors don’t know how an individual person might respond and don’t want to risk worsening their liver health.
The aim of the EMPOWER-B study is to find ways to predict what will happen if someone stops therapy. First, we will measure different forms of virus template in the liver (cccDNA and integrated DNA) using fine needle aspirates and new highly sensitive techniques invented by our lab. This is because we know that these templates can produce viral proteins and new viruses to restart infection. We predict that people with lower amounts of virus template in the liver will have better outcomes.
Because it is much easier to take blood than to sample liver cells, we will also be measuring different blood markers including virus proteins, antibodies, and immune cells. We will see if they reflect the amount of virus template and inflammation in the liver and if they can predict how well someone will do after stopping medication. Finally, it is possible that each marker only gives a little piece of the whole picture, so we will be combining them to generate an algorithm to help us predict relapse or cure.
Ultimately, through the EMPOWER-B study, we hope to identify people who can safely stop treatment, so it does not have to be life-long. We also hope that stopping treatment will cure hepatitis B in some people by allowing their own immune system to clear the virus.
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