Guidance on treatment endpoints and study design for clinical trials aiming to achieve cure in chronic hepatitis B and D: Report from the 2022 AASLD-EASL HBV/HDV treatment endpoints conference

Abstract

<p>Representatives from academia, industry, regulatory agencies, and patient advocacy groups convened under AASLD and EASL in June 2022 with the primary goal of achieving consensus on chronic hepatitis B virus (HBV) and hepatitis delta virus (HDV) (HDV) treatment endpoints to guide clinical trials aiming to "cure" HBV and HDV. Conference participants reached agreement on some key points. The preferred primary endpoint for phase II/III trials evaluating finite treatments for chronic hepatitis B (CHB) is "functional" cure, defined as sustained HBsAg loss and HBV DNA less than lower limit of quantification (LLOQ) 24 weeks off-treatment. An alternate endpoint would be "partial cure" defined as sustained HBsAg level <100 IU/mL and HBV DNA </p>