title: Histological disease in Asian-Americans with chronic hepatitis B, high hepatitis B virus DNA, and normal alanine aminotransferase levels.
abstract: OBJECTIVE
  At present there is no clear consensus on how patients with chronic hepatitis B (CHB), high serum hepatitis B virus (HBV) DNA, and normal alanine aminotransferase (NLALT) levels should be managed. This study hypothesizes that a significant proportion of such patients may have histological disease.
  
  
  METHODS
  We carried out a retrospective study of 101 consecutive treatment-naive patients with CHB who underwent liver biopsies at a community gastroenterology clinic and had high HBV DNA and NLALT (< or = 40 U/l) levels at the time of biopsy. All patients were Asians. ALT levels were observed for a period of time before liver biopsy and were used to classify patients into two groups, namely those with only NLALT levels and those with fluctuating ALT (FLALT) levels. All patients had at least two ALT measurements during this period of time. Significant histology was defined as stage > or = 2 fibrosis or stage 1 fibrosis plus grade > or = 2 inflammation using the Batts-Ludwig scoring system.
  
  
  RESULTS
  In patients with NLALT levels, the proportions of those with significant histology were 0, 22, and 45% for age < or = 35, 36-50, and >50 years, respectively (n=11, n=27, n=19; P=0.033). In patients who had FLALT levels, the corresponding proportions were 22, 42, and 69% (n=9, n=22, n=13; P=0.091). After adjustments for gender, hepatitis B e antigen (HBeAg) status, and mean pre-biopsy HBV DNA levels, significant predictors of histological disease were older age (odds ratio (OR)=6.2 for age 36-50 years and OR=17.6 for age >50 years compared with age < or = 35 years, P=0.041 and P=0.003, respectively) and FLALT levels (OR=3.6, P=0.008). Sub-analysis of patients with NLALT levels using lower cutoffs (30 U/l for men and 19 U/l for women) showed similar trends.
  
  
  CONCLUSIONS
  Patients with CHB, high HBV DNA, and NLALT levels and aged more than 35 years or those with FLALT levels may have significant histological disease (22-70%).
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, Stanford, California 94304, USA. mindiehn@stanford.edu
authors.forename: Mindie H
authors.initials: MH
authors.lastname: Nguyen
authors.forename: Ruel T
authors.initials: RT
authors.lastname: Garcia
authors.forename: Huy N
authors.initials: HN
authors.lastname: Trinh
authors.forename: Khoa D
authors.initials: KD
authors.lastname: Lam
authors.forename: Gerald
authors.initials: G
authors.lastname: Weiss
authors.forename: Huy A
authors.initials: HA
authors.lastname: Nguyen
authors.forename: Khanh K
authors.initials: KK
authors.lastname: Nguyen
authors.forename: Emmet B
authors.initials: EB
authors.lastname: Keeffe
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood*; D001213:Asian; D001706:Biopsy; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D006515:Hepatitis B virus; D019694:Hepatitis B, Chronic / Q000097:blood* / Q000473:pathology*; D006801:Humans; D008099:Liver / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D019562:Viral Load
chemical_list: D004279:DNA, Viral; D000410:Alanine Transaminase