Washington DC, July 28, 2020 – The Forum for Collaborative Research announced the publication of the manuscript, “Association Between Seroclearance of Hepatitis B Surface Antigen and Long-term Clinical Outcomes of Patients With Chronic HBV Infection: Systematic Review and Meta-analysis” in Clinical Gastroenterology and Hepatology.
“The association of HBsAg loss and improved outcomes has been previously accepted but the strength of the relationship lacked comprehensive evaluation,” said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research. “These findings reinforce the use of HBsAg loss as a surrogate marker in patients with chronic hepatitis B infection."
The manuscript is the product of the HBV Forum’s Surrogate Endpoints Working Group, led by Marion Peters, MD, AIDS Clinical Trial Group, and Oliver Lenz, PhD,Scientific Director, Janssen Research and Development.
“The loss of HBsAg improves clinical outcomes with a decrease in hepatocellular carcinoma, liver decompensation, and less need for liver transplantation,” Peters said. “Since current therapies have a low chance of HBsAg loss, this analysis supports the need for newer therapies.”
Data from 28 studies including 188,316 chronic hepatitis B (CHB) patients and 1,486,091 patient years of follow-up was analyzed.
“There are many biomarkers, some old and some new, to assess the outcome of new treatment for chronic HBV infection but this study shows that loss of HBsAg should be our goal for treatment endpoints in the coming years” said Harry Janssen, MD, PhD, Program Director, Toronto Centre for Liver Disease, University Health Network, and Co-Chair of the HBV Forum Steering Committee. “As HBV integrates into the host genome it is, unlike HCV infection, quite difficult to cure. HBsAg loss is difficult to achieve so we have put the bar high for new treatments to induce sustainable cure of HBV infection.”
The HBV Forum is a project of the Forum for Collaborative Research. The article is available online at https://doi.org/10.1016/j.cgh.2020.05.041.
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About the Forum for Collaborative Research
Founded in 1997, The Forum for Collaborative Research at the University of California Berkeley School of Public Health is a public/private partnership with a mission to catalyze clinical development and improve global health by facilitating research, informing policy, and advancing regulatory science. The Forum’s three-pronged approach (practice, research, education) accelerates safe drug development by increasing clarity, cooperation and innovation, while maintaining standards of evidence. Forum members work in clinical practice, research, academia, industry, regulatory authorities, and patient advocacy. Using proven models for stakeholder engagement they enhance clinical trial efficiency, support fair participation, and expand access programs. Current projects focus on cytomegalovirus (CMV), viral hepatitis B (HBV), human immunodeficiency virus (HIV), nonalcoholic fatty liver disease (NAFLD)/ nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and rare diseases.
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