Hello everyone, my name is Sarah and I am the study coordinator for EMPOWER‑B!
What is EMPOWER-B?
Evaluating Markers Predicting Off‑treatment Wellness and Early Remission in Hepatitis B (EMPOWER‑B) is a government-funded observational study. We closely monitor individuals with chronic hepatitis B who discontinue antiviral therapy, aiming to identify predictors of their outcomes.
Although current international guidelines support stopping treatment for those who are eligible, it is not common in clinical practice. This is because it is difficult to predict individual outcomes upon stopping therapy. Previous studies have shown that:
~20% of participants achieve functional cure (loss of HBsAg)
~30% remain off treatment with careful monitoring
50–70% must resume therapy
Our hypothesis is that the level of viral forms in the liver: covalently closed circular DNA (cccDNA) and integrated HBV DNA (iDNA), can help predict clinical outcomes. These markers persist in the liver despite ongoing antiviral therapy.
Methodology
We are collecting liver fine needle aspirates (FNA), a minimally invasive, low-risk alternative to traditional core liver biopsies, to assess these viral forms. We are also obtaining blood samples to measure biomarkers: HBV DNA, HBV RNA, HBsAg, HBcAg, HBeAg, and liver function tests.
Study Progress (so far): 26 participants recruited
FNAs collected from all participants
6 participants have achieved functional cure
4 participants have restarted treatment
We are now quantifying cccDNA and iDNA using our novel PCR assays and assessing their relationship with blood biomarkers and clinical outcomes.
What next?
We will analyse any correlations between liver viral markers and blood biomarkers to see if they can predict clinical outcomes. We aim to develop a predictive model to guide clinical decisions on treatment cessation.
If successful, EMPOWER‑B could enable safer, personalised treatment pathways using blood biomarkers. This has the potential to identify those who can safely stop treatment and maximise chance of achieving cure.