title: Outcomes of patients with chronic hepatitis B who do not meet criteria for antiviral treatment at presentation.
abstract: OBJECTIVE
  The availability of potent, well-tolerated, oral antivirals with low rates of resistance has led many experts to recommend liberalizing indications for the treatment of chronic hepatitis B (CHB). This study sought to determine the rate of transitions to an active phase of infection, the frequency of treatment initiation, and the clinical outcomes of patients with CHB who did not meet treatment criteria at presentation.
  
  
  METHODS
  We reviewed medical records of patients with CHB, seen in the liver clinics at the University of Michigan Health System from 1999 through 2010, who did not receive antiviral treatment within 6 months of presentation. We collected data on transitions between different phases of CHB, hepatitis B e antigen (HBeAg) seroconversion, loss of hepatitis B surface antigen (HBsAg), and the development of hepatocellular carcinoma (HCC). Data analyses were censored or truncated at the time of treatment initiation or development of an outcome.
  
  
  RESULTS
  Of the 234 patients analyzed, 52.1% were men (median age, 35 y), 72.2% were Asian, and 81.2% were HBeAg-negative. During a median follow-up period of 51 months, 19.2% of patients transitioned to a more active disease phase and 18.8% started antiviral therapy. Of the 44 HBeAg-positive patients, 4 patients (9%) had spontaneous HBeAg seroconversion. Nine HBeAg-negative patients but none of the HBeAg-positive patients lost HBsAg. The cumulative probability of HBsAg loss among HBeAg-negative patients was 1% at year 5 and 21% by year 10. No patients had flares of icteric hepatitis or hepatic decompensation. None of the HBeAg-positive patients developed HCC, whereas 2 HBeAg-negative patients developed HCC.
  
  
  CONCLUSIONS
  Careful monitoring of patients with CHB who did not meet treatment criteria at presentation permits timely initiation of treatment, with a low risk of adverse clinical outcomes, based on a retrospective study with a median follow-up period of 4.3 years. These findings indicate that current guidelines for initiating treatment are appropriate.
authors.affiliation: Division of Gastroenterology and Hepatology, University of Michigan Health System, Ann Arbor, Michigan.
authors.forename: Suna
authors.initials: S
authors.lastname: Yapali
authors.affiliation: Division of Gastroenterology and Hepatology, University of Michigan Health System, Ann Arbor, Michigan.
authors.forename: Nizar
authors.initials: N
authors.lastname: Talaat
authors.affiliation: Division of Gastroenterology and Hepatology, University of Michigan Health System, Ann Arbor, Michigan.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Fontana
authors.affiliation: Division of Gastroenterology and Hepatology, University of Michigan Health System, Ann Arbor, Michigan.
authors.forename: Kelly
authors.initials: K
authors.lastname: Oberhelman
authors.affiliation: Division of Gastroenterology and Hepatology, University of Michigan Health System, Ann Arbor, Michigan. Electronic address: aslok@umich.edu.
authors.forename: Anna S
authors.initials: AS
authors.lastname: Lok
mesh_terms: D000046:Academic Medical Centers; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000453:epidemiology*; D005260:Female; D006297:Health Services Accessibility; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D006801:Humans; D008297:Male; D008824:Michigan; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents
keywords: Antiviral Agent; Cancer; HBV Infection; Management