Progression Rates by Age, Sex, Treatment, and Disease Activity by AASLD and EASL Criteria: Data for Precision Medicine.

Antiviral treatment criteria are based on disease progression risk, and hepatocellular carcinoma (HCC) surveillance recommendations for patients with chronic hepatitis B (CHB) without cirrhosis is based on an annual incidence threshold of 0.2%. However, accurate and precise disease progression estimate data are limited. Thus, we aimed to determine rates of cirrhosis and HCC development stratified by age, sex, treatment status and disease activity based on the 2018 AASLD and 2017 EASL guidelines. We analyzed 18,338 patients (8914 treated; 9424 untreated) from 6 centers from the US and 27 centers from Asia Pacific countries. The Kaplan-Meier method was used to estimate annual progression rates to cirrhosis or HCC in person-years. The cohort was 63% male, with a mean age of 46.19 years, baseline cirrhosis of 14.3%, and median follow up of 9.60 years. By AASLD criteria, depending on age, sex, and disease activity, annual incidence rates ranged from 0.07%-3.94% for cirrhosis, from 0.04%-2.19% for HCC in patients without cirrhosis, and 0.40%-8.83% for HCC in patients with cirrhosis. Several subgroups of patients without cirrhosis including males younger than 40 and females younger than 50 had annual HCC risk near or exceeding 0.2%. Similar results were found using EASL criteria. There is great variability in CHB disease progression rates even among "lower risk" populations. Future CHB modeling studies, public health planning, and HCC surveillance recommendation should be based on more precise disease progression rates based on sex, age, disease activity, plus treatment status.