title: NICE guidelines and a treatment algorithm for the management of chronic hepatitis B: a review of 12 years experience in west London.
abstract: BACKGROUND
  Treatment strategies in chronic hepatitis B (CHB) are evolving as more potent oral antivirals become available. However, drug resistance remains a major challenge and policy guidelines on management are limited by the evidence base. This study aims to review the implications of the National Institute for Health and Clinical Excellence (NICE) guidelines in a cohort of unselected CHB patients in the United Kingdom and to evolve a management algorithm for their treatment.
  
  
  METHODS
  In total, 783 unselected hepatitis B surface antigen-positive patients, were assessed of whom 212 (27%) underwent liver biopsy. Age, alanine aminotransferase, hepatitis B virus DNA and necroinflammatory score were analysed to determine their value as predictors of fibrosis. Patients with biopsy evidence of fibrosis were offered treatment and followed longitudinally. Six-month on-treatment virologic response was evaluated to determine the validity of this strategy in predicting the early emergence of resistance.
  
  
  RESULTS
  Age, gender and necroinflammatory score were predictors of fibrosis in CHB patients, whereas age > 40 years was a predictor of cirrhosis in both hepatitis B e antigen (HBeAg)-positive (P < 0.03) and HBeAg-negative patients (P < 0.003). A total of 81% of HBeAg-positive and 65% of HBeAg-negative CHB patients who required adefovir add-on therapy were identifiable after 6 months of lamivudine monotherapy, by continuing HBV DNA positivity (P < 0.002 and P < 0.0001, respectively).
  
  
  CONCLUSIONS
  Advanced liver disease was present in patients falling outside current treatment guidelines, highlighting the importance of liver histology in identifying fibrosis and the need for antiviral therapy. While 6 month on-treatment virologic response as a trigger for instituting add-on therapy may be an improvement on the current recommendations, such a strategy should be integrated into any new treatment algorithm, likely to consist of entecavir and tenofovir.
authors.affiliation: Department of Hepatology, Imperial College London at St Mary's Hospital, London, UK.
authors.forename: Patrick T F
authors.initials: PT
authors.lastname: Kennedy
authors.forename: Heather C
authors.initials: HC
authors.lastname: Lee
authors.forename: Lukshmy
authors.initials: L
authors.lastname: Jeyalingam
authors.forename: Raza
authors.initials: R
authors.lastname: Malik
authors.forename: Peter
authors.initials: P
authors.lastname: Karayiannis
authors.forename: David
authors.initials: D
authors.lastname: Muir
authors.forename: Janice
authors.initials: J
authors.lastname: Main
authors.forename: Mark
authors.initials: M
authors.lastname: Thursz
authors.forename: Robert
authors.initials: R
authors.lastname: Goldin
authors.forename: Belinda
authors.initials: B
authors.lastname: Smith
authors.forename: Ashley
authors.initials: A
authors.lastname: Brown
authors.forename: Howard C
authors.initials: HC
authors.lastname: Thomas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000410:Alanine Transaminase / Q000097:blood; D000465:Algorithms; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D007249:Inflammation; D008103:Liver Cirrhosis / Q000188:drug therapy; D008131:London / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000410:Alanine Transaminase