Treatment recommendations for chronic hepatitis B: An evaluation of current guidelines based on a natural history study in the United States

Abstract

Current guidelines for treatment of chronic hepatitis B include hepatitis B e antigen (HBeAg) status, levels of hepatitis B virus (HBV) DNA, and serum alanine aminotransferase (ALT) values in the setting of either chronic hepatitis or cirrhosis. Based on findings from a prospective study of hepatitis B surface antigen (HBsAg)‐positive patients, we determined whether these guidelines included patients who developed hepatocellular carcinoma (HCC) and who died of non‐HCC liver‐related complications. The criteria for treatment from four published guidelines were matched to a cohort of 369 HBsAg‐positive patients enrolled in the study. During a mean follow‐up of 84 months, 30 patients developed HCC and 37 died of non‐HCC liver‐related deaths. Using criteria for antiviral therapy as stated by the four guidelines, only 20%‐60% of the patients who developed HCC, and 27%‐70% of patients who died of non‐HCC liver‐related deaths would have been identified for antiviral therapy according to current treatment recommendations. If baseline serum albumin levels of 3.5 mg/dL or less or platelet counts of 130,000 mm³ or less were added to criteria from the four treatment guidelines, then 89%‐100% of patients who died of non‐HCC liver‐related complications, and 96%‐100% of patients who developed HCC would have been identified for antiviral therapy. In addition, if basal core promoter T1762/A1764 mutants and precore A1896 mutants also were included, then 100% of patients who developed HCC would have been identified for treatment. Conclusion: This retrospective analysis showed that the current treatment guidelines for chronic hepatitis B excluded patients who developed serious liver‐related complications. (HEPATOLOGY 2008.)