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Natural history and disease progression in Chinese chronic hepatitis B patients in immune‐tolerant phase

In view of the findings that high hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is associated with increased risk of chronic hepatitis B (CHB)–related complications, disease progression in CHB patients in the immune‐tolerant phase is uncertain. We evaluated disease progression in 57 immune‐tolerant CHB patients with high HBV DNA. Each subject underwent an initial liver biopsy. In those who remained in the immune‐tolerant phase, a follow‐up liver biopsy was performed after 5 years of follow‐up. Patients who developed elevated serum alanine aminotransferase (ALT) levels were discontinued from the study after a follow‐up liver biopsy. Disease progression was defined as a 1‐point increase in fibrosis stage. Initial liver biopsies showed the median fibrosis stage of the study patients was 1 (range 0–1). By the end of follow‐up, 9 of the 57 patients (15.8%) had developed elevated serum ALT. In those who remained in the immune‐tolerant phase, follow‐up fibrosis stage was comparable with the initial fibrosis stage (P = 0.58). However, disease progression was greater in patients who developed elevated serum ALT when compared with those who remained in the immune‐tolerant phase (5 of 9 vs. 3 of 48, respectively, P = 0.001). The median rate of fibrosis progression of patients who remained in the immune‐tolerant phase was lower than that of patients with high serum ALT (0 U/year [range −0.40–0.20 U/year] versus 0.21 U/year [range 0–1.11 U/year], respectively, P = 0.04). Conclusion: CHB patients in the immune‐tolerant phase have mild disease. In those who remained in the immune‐tolerant phase in the present study, disease progression was minimal. However, immune‐tolerant patients who progressed to the immune clearance phase often faced disease progression. (HEPATOLOGY 2007.)