Progression to cirrhosis, hepatocellular carcinoma and liver related mortality in chronic hepatitis B patients in Italy.

Background: The natural history of chronic hepatitis B is variable. We evaluated some risk factors for cirrhosis, hepatocellular carcinoma and liver-related mortality in Italian patients with chronic hepatitis B. Methods: A cohort of 105 untreated patients with chronic hepatitis B without cirrhosis at diagnosis was followed prospectively for a mean period of 23 years. Clinical, histological and ultrasound examinations, biochemical and virologic tests, and causes of death were analyzed. Results: Forty two (40%) patients became inactive carriers and 63 (60%) showed persistent alanine aminotransferase elevation: 13 (13%) associated with HBeAg persistence, 35 (33%) with detectable serum HBV-DNA but HBeAg-negative, 11 (10%) with concurrent virus infection and 4 (4%) with non alcoholic fatty liver disease. Cirrhosis incidence was 1.56/100 person-years. Older age and sustained HBV replication predicted cirrhosis occurrence independently. Hepatocellular carcinoma incidence was 2.1/100 person-years in patients who developed cirrhosis and 0.06 in those who did not. Cirrhosis occurrence was associated with an increased risk of hepatocellular carcinoma (Hazard ratio 20.4, 95% confidence interval 2.54-167.5) and liver-related death (16.5, 2.0-138.8). Conclusions: In Italian patients with chronic hepatitis B cirrhosis strongly predicts hepatocellular carcinoma occurrence and disease-related mortality, thus indicating that early antiviral treatment should be instituted before cirrhosis occurrence.