title: Optimization of adefovir therapy in chronic hepatitis B according to baseline predictors and on-treatment HBV DNA: a 5-year prospective study.
abstract: BACKGROUND
  Adefovir Dipivoxil (ADV) is an important agent to suppress hepatitis B virus (HBV) replication with suboptimal effect on virological and serological response. To optimize Adefovir therapy in chronic hepatitis B (CHB) patients with hepatitis B e antigen (HBeAg) positive, we studied the baseline parameters and on-treatment HBV DNA for favorable outcomes.
  
  
  METHODS
  48 patients were enrolled in the study and followed up for 5 years prospectively. Baseline characteristics, virological, serological and biochemical parameters as well as on treatment HBV DNA were assessed in prediction of favorable outcomes.
  
  
  RESULTS
  1. The patients with baseline alanine aminotransferase (ALT) ≥5 × the upper limit of normal (ULN, 40 IU/L) had higher rates of viral response (VR), HBeAg loss and HBeAg seroconversion at year 5 compared to the patients with ALT < 5 × ULN (VR: 75% vs 43.8%, p = 0.035; HBeAg loss: 43.9% vs 13.8%, p = 0.017; HBeAg seroconversion: 37.9% vs 13.8%, p = 0.035); Patients with baseline HBV DNA < 10(9) copies/ml and ALT ≥3 × ULN had more chance of HBeAg seroconversion (40.9% vs 8.7%, p = 0.012), while in patients with HBeAg < 800 s/co or HBsAg < 5000 IU/ml higher rates of HBeAg loss were achieved. 2. HBV DNA level < 10(4) copies/ml at week 24 was predictive for VR (96.0% vs 40.9%, P < 0.001), HBeAg loss (84.0% vs 36.3%, P = 0.001) and HBeAg seroconversion (36.0% vs 9.1%, P = 0.030).
  
  
  CONCLUSIONS
  ADV treatment should be started for patients with baseline ALT≥5 × ULN or patients with ALT≥3 × ULN and HBV DNA < 10(9) copies/ml. Lower level of HBeAg(< 800 s/co) and HBsAg(< 5000 IU/ml) may be regarded as referenced factors. In patients with serum HBV DNA < 10(4) copies/ml at week 24 the therapy should continue, and a favorable outcome may be achieved in 5 years or longer.
authors.affiliation: Jinan Infectious Disease Hospital, affiliated to Shandong University, Jinan, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Lu
authors.forename: Da Ying
authors.initials: da Y
authors.lastname: Geng
authors.forename: Fei
authors.initials: F
authors.lastname: Shen
authors.forename: Jing Yao
authors.initials: JY
authors.lastname: Zhang
authors.forename: Bing
authors.initials: B
authors.lastname: Lu
authors.forename: Li Xian
authors.initials: LX
authors.lastname: Ma
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000032:analysis* / Q000378:metabolism; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D015415:Biomarkers / Q000032:analysis; D002681:China; D005260:Female; D005500:Follow-Up Studies; D006514:Hepatitis B Surface Antigens / Q000032:analysis / Q000276:immunology; D006513:Hepatitis B e Antigens / Q000032:analysis / Q000276:immunology; D006515:Hepatitis B virus / Q000187:drug effects* / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology* / Q000378:metabolism / Q000821:virology; D006801:Humans; D008297:Male; D063065:Organophosphonates / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D000410:Alanine Transaminase; D000225:Adenine; C106812:adefovir dipivoxil