EASL 2025 indications revisited: phase-specific outcomes with and without nucleos(t)ide analogue therapy in chronic hepatitis B virus infection
Year: 2025
Type: article
Study design: Observational Study
Abstract: OBJECTIVE: The impact of nucleos(t)ide analogues (NAs) therapy on the long-term outcomes in chronic HBV infection individuals outside 2025 European Association for the Study of the Liver (EASL) strongly recommended treatment indications remains uncertain. We aimed to assess the association between NAs therapy and the risks of cirrhosis and hepatocellular carcinoma (HCC) in Chinese chronic HBV infection individuals outside these criteria. DESIGN: We analysed data from 30 784 chronic HBV infection individuals across 12 centres in China. We categorised individuals outside 2025 EASL strongly recommended treatment criteria into four groups: (1) hepatitis B e antigen (HBeAg)-positive, high replicative (age <30, HBV DNA ≥8 log₁₀IU/mL, normal alanine aminotransferase (ALT), no/mild fibrosis, no family history of liver cancer); (2) HBeAg-positive, impending phase transition (typically age ≥30, HBV DNA ≥6 log₁₀IU/mL, normal ALT, no advanced fibrosis); (3) HBeAg-negative, low replicative (HBV DNA <3.3 log₁₀IU/mL, normal ALT, no/mild fibrosis); (4) HBeAg-negative, high replicative, low-risk (HBV DNA 3.3-4.3 log₁₀IU/mL, normal ALT, no/mild fibrosis). The primary endpoints were the incidence of cirrhosis and HCC. RESULTS: Up to 5 years of follow-up (117 814 person-years), we documented 635 incident cirrhosis and 164 HCC cases. In multivariable analyses, NA therapy significantly reduced risks of cirrhosis (HR 0.18, 95% CI 0.11 to 0.32) and HCC (HR 0.03, 95% CI 0.01 to 0.21) in Group 1, and cirrhosis (HR 0.50, 95% CI 0.41 to 0.61) and HCC (HR 0.25, 95% CI 0.16 to 0.41) in Group 2. No significant associations were observed in Groups 3 and 4. Findings were consistent in propensity score matching analyses. CONCLUSION: NAs therapy was associated with reduced risks of cirrhosis and HCC in HBeAg-positive individuals with high replicative or impending phase transition phenotypes, supporting the expansion of chronic HBV infection treatment criteria.
Source: Gut
Authors: Shichuan Tang, Tingfeng Huang, Ruijing Tang, Kongying Lin, Cong Luo, Yubing Shen, Kailing Zhang, Yidan Tang, Jie Kong, Zhenwei Chen, Jun Fu, Qizhu Lin, Luobin Guo, Yeye Wu, Yuntong Li, Jianxi Zhang, Zhenghong Sun, Penghui You, Daichang Zhang, Yanxin Chen, Xin Lin, Chengqian Zhong, Zhipeng Lin, Hongzhi Liu, Zuxiong Huang, Weiping Zhou, Peiling Dong, Xiaolong Liu, Hongmei Zeng, Xiaolong Qi, Yongyi Zeng
Institutions: Fujian Medical University, Mengchao Hepatobiliary Hospital, First Affiliated Hospital of Fujian Medical University, Chinese Academy of Medical Sciences & Peking Union Medical College, State Key Laboratory of Molecular Oncology, Sichuan University, Shandong First Medical University, Eastern Hepatobiliary Surgery Hospital, Zhongshan Hospital of Xiamen University, Ningde Normal University, Capital Medical University, Beijing YouAn Hospital, Zhongda Hospital Southeast University, Southeast University
Language: English
Topic: Hepatitis B Virus Studies
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4415608589