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Extremely low risk of hepatocellular carcinoma development in patients with chronic hepatitis B in immune‐tolerant phase

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‐...

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Published in:Alimentary pharmacology & therapeutics 2020-07, Vol.52 (1), p.196-204
Main Authors: 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, Yong‐Han, Lee, Jin‐Woo, Suh, Sang Jun, Jung, Young Kul, Kim, Beom Kyung, Park, Jun Yong, Kim, Do Young, Ahn, Sang Hoon, Han, Kwang‐Hyub, Yim, Hyung Joon, Kim, Seung Up
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Language:English
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Summary: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 log10 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 >107 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  107 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.
ISSN:0269-2813
1365-2036
DOI:10.1111/apt.15741