Internal medicine

Clinical endpoint

Virus

Discontinuation

Gastroenterology

Surrogate endpoint

cccDNA

HBeAg

Immunology

Hepatitis B

HBsAg

Hepatitis B virus

Chronic hepatitis

Clinical trial

Medicine

Journal of Hepatology

Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to ‘cure’ HBV. Agreement among the conference participants was reached on some key points. ‘Functional’ but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in ≥30% of patients was suggested as an acceptable rate of response in these trials.

Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conference‡