title: 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 mm(3) 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.
  
  
  CONCLUSIONS
  This retrospective analysis showed that the current treatment guidelines for chronic hepatitis B excluded patients who developed serious liver-related complications.
authors.affiliation: The Pfleger Liver Institute and the Division of Digestive Diseases, David Geffen School of Medicine at the University of California in Los Angeles, CA, USA. myrontong@hmri.org
authors.forename: Myron John
authors.initials: MJ
authors.lastname: Tong
authors.forename: Carlos
authors.initials: C
authors.lastname: Hsien
authors.forename: Leeyen
authors.initials: L
authors.lastname: Hsu
authors.forename: Hai-En
authors.initials: HE
authors.lastname: Sun
authors.forename: Lawrence Mitchell
authors.initials: LM
authors.lastname: Blatt
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000150:complications / Q000188:drug therapy; D004279:DNA, Viral / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics; D006514:Hepatitis B Surface Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008113:Liver Neoplasms / Q000150:complications / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D012189:Retrospective Studies; D014481:United States
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D000410:Alanine Transaminase