title: [Efficacy of 104-week sequential therapy with telbivudine or entecavir in HBeAg-positive chronic hepatitis B patients with suboptimal responses to 24-week therapy with pegylated interferon-α-2a].
abstract: OBJECTIVE
  To investigate the efficacy and safety of 104-week sequential therapy with telbivudine or entecavir in HBeAg-positive chronic hepatitis B (CHB) patients with suboptimal responses to 24-week pegylated interferon-α-2a (PEG-IFN-α-2a) therapy.
  
  
  METHODS
  A total of 130 HBeAg-positive CHB patients with HBV DNA≥5.0 lg IU/ml and a reduction in HBsAg quantitation < 1 lg IU/ml compared with baseline who received PEG-IFN-α-2a therapy for 24 weeks were enrolled and randomly divided into telbivudine group and entecavir group, and 5 of them were lost. HBeAg clearance rate and seroconversion rate, HBV DNA clearance rate, safety, and drug resistance rate at week 104 were observed. The t-test, chi-square test, or multivariate Cox regression analysis were used for statistical analysis of different types of data.
  
  
  RESULTS
  At week 104 of treatment, HBV DNA clearance rate showed no significant difference between the telbivudine group and entecavir group (P = 0.363), and the telbivudine group had significantly higher HBeAg clearance rate and HBeAg seroconversion rate than the entecavir group (HBeAg clearance rate: 61.29% vs 23.81%, P < 0.01; HBeAg seroconversion rate: 51.61% vs 19.05%, P < 0.01). Male sex and telbivudine therapy were baseline predictors of HBeAg seroconversion. The multivariate Cox regression analysis (Forward LR, a = 0.05) showed that the presence or absence of HBeAg seroconversion at week 104 was significantly associated with male sex (HR = 4.917), a reduction in HBsAg > 0.5 lg IU/ml at week 12 of treatment compared baseline (HR = 3.514), and a reduction in HBeAg > 1 lg COI at week 12 of treatment compared baseline (HR = 8.651).
  
  
  CONCLUSIONS
  In HBeAg-positive CHB patients with suboptimal responses to 24-week PEG-IFNα-2a therapy, the sequential therapy with telbivudine helps achieve better HBeAg clearance rate and seroconversion rate compared with the sequential therapy with entecavir and can be used as a therapeutic regimen for such patients. A reduction in HBeAg > 1 lg COI at week 12 of treatment compared baseline can be used as a predictive factor for HBeAg seroconversion at week 104.
authors.affiliation: Department of Infectious Diseases, Guangdong Academy of Medical Science, Guangdong General Hospital, Guangzhou 050110, China.
authors.forename: X D
authors.initials: XD
authors.lastname: Luo
authors.forename: X P
authors.initials: XP
authors.lastname: Chen
authors.forename: R
authors.initials: R
authors.lastname: Chen
authors.forename: X F
authors.initials: XF
authors.lastname: Chen
authors.forename: J
authors.initials: J
authors.lastname: Huang
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D000077712:Telbivudine; D013936:Thymidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000077712:Telbivudine; D011092:Polyethylene Glycols; C413685:entecavir; D006147:Guanine; C100416:peginterferon alfa-2a; D013936:Thymidine