医学
临床终点
乙型肝炎表面抗原
临床试验
内科学
乙型肝炎
慢性肝炎
代理终结点
cccDNA
丁型肝炎病毒
HBeAg
乙型肝炎病毒
胃肠病学
免疫学
病毒
作者
Marc G. Ghany,Marı́a Buti,Pietro Lampertico,Hannah M. Lee
标识
DOI:10.1016/j.jhep.2023.06.002
摘要
Representatives from academia, industry, regulatory agencies, and patient advocacy groups convened under the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) in June 2022 with the primary goal of achieving consensus on chronic HBV and HDV treatment endpoints to guide clinical trials aiming to "cure" HBV and HDV. Conference participants reached an agreement on some key points. The preferred primary endpoint for phase II/III trials evaluating finite treatments for chronic hepatitis B (CHB) is a "functional" cure, defined as sustained HBsAg loss and HBV DNA less than the lower limit of quantitation (LLOQ) 24 weeks off-treatment. An alternate endpoint would be "partial cure" defined as sustained HBsAg level <100 IU/mL and HBV DNA
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