Evaluation of Alanine Transaminase and Hepatitis B Virus DNA to Predict Liver Cirrhosis in Hepatitis B e Antigen-Negative Chronic Hepatitis B Using Transient Elastography

BACKGROUND AND AIMS: We aimed to investigate the relationship between serum hepatitis B virus (HBV) DNA and alanine transaminase (ALT) levels and the risk of cirrhosis in a large cohort of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients based on transient elastography. METHODS: We prospectively studied treatment-naive HBeAg-negative patients recruited based on territory-wide referrals. We defined possible cirrhosis and probable cirrhosis with two different cutoffs according to the results from a subgroup of patients with histologic proof. RESULTS: One thousand one hundred ninety-seven patients with successful liver stiffness measurement (LSM) were studied. In the subgroup of 100 patients with liver biopsy, LSM of >= 8.4 kiloPascal (kPa) had a sensitivity of 90% and LSM of >= 13.4 kPa had a specificity of 94% for liver cirrhosis. Possible and probable cirrhosis were defined as a LSM value >= 8.4 kPa and >= 13.4 kPa, and were present in 31% and 11% of the patients, respectively. The risk of cirrhosis was significantly increased when ALT level was > 0.5x upper limit of normal (ULN) or serum HBV DNA > 4 log(10) copies/mL. Among patients who have ALT <= 0.5 x ULN and HBV DNA <= 4 log(10) copies/mL, 10% (26/264) and 3% (7/264) had possible and probable cirrhosis respectively, which were significantly lower when compared with 34% (329/887, P < 0.001) and 14% (125/887, P < 0.001) of those who had higher ALT and HBV DNA levels. CONCLUSIONS: Liver cirrhosis was common among HBeAg-negative CHB patients. Patients with ALT levels > 0.5 x ULN and/or serum HBV DNA > 4 log(10) copies/mL have higher risk of cirrhosis and need further assessment for antiviral therapy. (Am J Gastroenterol 2008;103:3071-3081).