Chronic hepatitis B: a long-term retrospective cohort study of disease progression in Shanghai, China.

BACKGROUND AND AIMS: The present study aimed to describe the disease progression of chronic hepatitis B patients without or with compensated cirrhosis at baseline, to estimate the risk of progression to decompensated cirrhosis, hepatocellular carcinoma and death, and to determine prognostic factors of disease progression in patients in Shanghai, China.
METHODS: Stored medical records from 322 biopsy-confirmed chronic hepatitis B cases diagnosed between 1981 and 1993 were selected, and the status of patients was tracked in 1999-2000. Among consenting patients, ultrasound examination and laboratory tests were conducted. Person-year incidence rates, Kaplan-Meier analysis, log-rank tests, and Cox regression analysis were conducted.
RESULTS: Among chronic hepatitis B patients without compensated cirrhosis, the incidence rates of decompensated cirrhosis, hepatocellular carcinoma, and death were 6.3, 2.8, and 7.6 per 1000 person-years, respectively, while for patients with compensated cirrhosis, the rates were 35.6, 8.2, and 35.2 per 1000 person-years, respectively. The 15-year survival rate was 88% for patients without compensated cirrhosis, compared with 56% for patients with compensated cirrhosis (P < 0.001). Cox regression analysis demonstrated that increased alpha-fetoprotein (AFP) (P < 0.01), gamma-globulin (P < 0.05), and high-level severity of hepatic fibrosis (P < 0.01) at baseline were risk factors of decompensated cirrhosis. Factors associated with a high risk of death included elevated AFP at baseline (P < 0.01), severity of hepatic fibrosis (P < 0.003), and sustained positivity for hepatitis B surface antigen (P < 0.004).
CONCLUSION: Increased AFP and severity of hepatic fibrosis at baseline were associated with higher risk of decompensated cirrhosis and death. These data provide rare empirical estimates of the negative long-term outcomes for patients with chronic hepatitis B in Shanghai, China.