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Extremely low risk of hepatocellular carcinoma development in patients with chronic hepatitis B in immune‐tolerant phase
Author(s) -
Lee Han Ah,
Lee Hyun Woong,
Kim In Hee,
Park Soo Young,
Sinn Dong Hyun,
Yu Jung Hwan,
Seo Yeon Seok,
Um Soon Ho,
Lee Jung Il,
Lee Kwan Sik,
Lee Chang Hun,
Tak Won Young,
Kweon Young Oh,
Kang Wonseok,
Paik YongHan,
Lee JinWoo,
Suh Sang Jun,
Jung Young Kul,
Kim Beom Kyung,
Park Jun Yong,
Kim Do Young,
Ahn Sang Hoon,
Han KwangHyub,
Yim Hyung Joon,
Kim Seung Up
Publication year - 2020
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.15741
Subject(s) - medicine , hepatocellular carcinoma , hazard ratio , immune system , gastroenterology , hepatitis b , population , incidence (geometry) , cumulative incidence , hepatitis b virus , immunology , confidence interval , virus , physics , transplantation , environmental health , optics
Summary Background Anti‐viral therapy is not indicated for patients with chronic hepatitis B (CHB) in the immune‐tolerant phase. Aims To investigate the cumulative incidence of phase change and hepatocellular carcinoma (HCC) and independent predictors for phase change in patients with CHB in immune‐tolerant phase. Methods In total, 946 patients in immune‐tolerant phase, defined as hepatitis B e antigen positivity, HBV‐DNA >20 000 IU/mL and alanine aminotransferase (ALT) ≤40 IU/L, between 1989 and 2017 were enrolled from eight institutes. Results The mean age of study population (429 men and 517 women) was 36.7 years. The mean ALT and HBV‐DNA levels were 24.6 IU/L and 8.50 log 10 IU/mL, respectively. Of the study population, 476 (50.3%) patients remained in immune‐tolerant phase throughout the study period (median: 63.6 months). The cumulative incidence rates of phase change and HCC at 10 years were 70.7% and 1.7%, respectively. Multivariate analyses revealed that HBV‐DNA level >10 7 IU/mL was associated independently with a reduced risk of phase change (hazard ratio [HR] = 0.734, P = 0.008), whereas a high ALT level, above the cut‐off recommended in the Korean Association for the Study of the Liver guidelines (34 IU/L for men and 30 IU/L for women), was associated independently with a greater risk of phase change (HR = 1.885, P < 0.001). Conclusions The criterion of HBV‐DNA level > 10 7 IU/mL may be useful to define immune‐tolerant phase. In addition, an extremely low risk of HCC development was observed in patients with CHB in immune‐tolerant phase.