Long‐Term Dynamic Changes of Alanine Aminotransferase Levels Are Associated With Liver‐Related Events in Nucleos(t)ide Analogue‐Treated Chronic Hepatitis B Patients in China

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BACKGROUND: The role of alanine aminotransferase (ALT) dynamics during nucleos(t)ide analogue (NA) therapy in chronic hepatitis B (CHB) is unclear. We aimed to evaluate the correlation between ALT dynamics and liver-related events (LRE), and explore the optimal threshold of ALT during NA treatment. METHODS: percentile of the trajectory group with the lowest LRE risk was obtained as the optimal threshold. RESULTS: During a median follow-up of 53.3 months, 1164 patients developed LRE with a 7-year cumulative incidence of 9.9%. In the Search-B cohort, LCMM recognised 3 trajectory groups with progressively increasing ALT levels, which were positively associated with LRE risk. Subsequently, the optimal thresholds for ALT were obtained as 23 U/L for men and 16 U/L for women. The 7-year cumulative incidence of LRE was 5.5% for ALT ≤ 23 or 16 U/L, significantly lower than that for ALT > 23 or 16 U/L but ≤ 40 U/L (10.8%; aHR = 2.0, p < 0.001), and ALT > 40 U/L (15.1%; aHR = 3.4, p < 0.001). Similarly, in the Hong Kong cohort, ALT > 23 or 16 U/L but < 40 U/L and ALT > 40 U/L also increased the LRE risk, with aHRs of 2.0 (p = 0.003) and 6.1 (p < 0.001), respectively. CONCLUSION: On-treatment ALT levels were significantly correlated with the prognosis of CHB. ALT ≤ 23 U/L for men and ≤ 16 U/L for women were identified as the optimal thresholds during NA treatment, suggesting that CHB patients should strive for a lower ALT level beyond the traditional normal range.