title: Baseline prognostic factors and statistic model to predict early virological response in telbivudine-treated patients with chronic hepatitis B.
abstract: BACKGROUND
  Hepatitis B virus (HBV) infection is still a worldwide disease, which may cause liver cirrhosis or even hepatocellular carcinoma. Telbivudine is a potent nucleoside analogue used in the treatment of chronic hepatitis B (CHB); however, drug resistance has remained a challenge. As early virological response can predict long-term efficacy of nucleotide analogue treatment, numerous studies have been conducted in this area.
  
  
  OBJECTIVE
  The aim of this study was to establish baseline prognostic factors and a statistical model to predict early virological response in telbivudine-treated CHB patients.
  
  
  METHODS
  One hundred and eight CHB patients without any experience of nucleotide analogue therapy were assigned to receive telbivudine (600 mg, once daily) for at least 24 weeks, and then were followed up every two weeks. Cox proportional hazard regression model analyses were employed to evaluate baseline variables, and further developing a statistical model to predict early virological response.
  
  
  RESULTS
  Negative family history of HBV infection (P = 0.000235), baseline higher serum TBIL (P = 0.038714) and AST (P = 0.020684) concentrations, and lower level of HBV-DNA (P = 0.0034784) were identified to be associated with higher possibility of early virological response. A model was established based on these variables to calculate the risk scores (R) for CHB patients. R > -0.38 suggested early virological response to telbivudine. The model was validated among an independent set of 20 patients.
  
  
  CONCLUSIONS
  Family history as well as baseline bilirubin, AST and HBV DNA levels can predict early virological response. The model provides a better tool for response prediction based on the four prognostic factors.
authors.affiliation: Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China ; Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Zhou
authors.affiliation: Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Yuan-Ping
authors.initials: YP
authors.lastname: Zhou
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Chun
authors.initials: C
authors.lastname: Lin
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Hai-Bing
authors.initials: HB
authors.lastname: Gao
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Shui-Wen
authors.initials: SW
authors.lastname: Huang
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Zu-Xiong
authors.initials: ZX
authors.lastname: Huang
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Sun
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Lin
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Dong-Qing
authors.initials: DQ
authors.lastname: Zhang
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Qing-Feng
authors.initials: QF
authors.lastname: Lin
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Ao
authors.affiliation: Infectious Disease Hospital, Meng Chao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Chen
authors.initials: C
authors.lastname: Pan
keywords: Hepatitis B, Chronic; Proportional Hazards Models; Telbivudine; Virology