I hope you are doing well. I have recently joined Thomas Tu and Mark Douglas’s group as a postdoctoral researcher and project manager. We are thrilled to share with you that we have an exciting new project on the horizon, ready to kick off soon. The project is titled, Evaluating Markers Predicting Off-treatment Wellness and Early Remission in Hepatitis B or EMPOWER-B for short.
Hepatitis B treatment is generally life-long (with entecavir or tenofovir). As some of you know, life-long therapy is not ideal. So, some studies have looked at what happens if people who have highly suppressed virus levels stop their antiviral medications. They found most will undergo virological relapse (virus infection comes back), some will maintain virological control (virus levels stay low), and others will clear the infection (HBsAg-loss) – we simply cannot predict what will happen! Virological relapse is driven by covalently closed circular DNA (cccDNA) and integrated DNA (iDNA) genomes in the liver. Unfortunately, these cannot be easily detected using current methods. Therefore, novel surrogate markers to predict virus relapse after treatment cessation is much needed. The EMPOWER-B study aims to develop novel biomarkers to predict who can safely stop treatment.
We aim to recruit about 130 patients who are HBeAg negative and meet the international criteria to stopping therapy (non-cirrhotic patients who are well controlled on antiviral therapy with undetectable HBV DNA for at least 3 years. We will monitor these patients closely over 4 years and keep track of the levels of the various biomarkers of interest such as cccDNA and iDNA (from fine needle aspirates), cell-free DNA, HBV Core, HBV RNA, HBV DNA and capsid antibody complexes. We will include frequent liver function tests, fibroscans and other blood tests to monitor and ensure the well-being of our patients.
By the end of the study, we hope to develop a clinical algorithm to predict responses to treatment cessation, which will help cure rates for patients with hepatitis B using our current clinical tools.
Thanks for your time and happy to take any questions