title: [Efficacy of combination therapy with peginterferon alfa-2alpha and bicyclol in chronic hepatitis B with high ALT levels].
abstract: OBJECTIVE
  To evaluate the effect of combination therapy with peginterferon alfa-2a (Pegasys) +/- nucleos(t)ide analogues (NUC) and bicyclol in chronic hepatitis B with high ALT levels at baseline and during early treatment.
  
  
  METHODS
  CHB patients were treated with PEG-IFNalpha-2a for a minimum of 48 weeks. All patients were followed up for 26 weeks post-treatment. Patients with HBV DNA > or = 1 x 10(8) copies/ml were combined with NUC (adefovir or entecavir) treatment. Patients with ALT > 500 U/L at baseline or ALT > 300 U/L after first injection of PEG-IFNalpha-2a received bicyclol treatment for 1-2 months (treatment group). Patients with 2 x ULN < ALT < 300 U/L and ALT < 300 U/L during treatment were enrolled into PEG-IFNalpha-2a +/- NUC antiviral monotherapy (control group). Responses defined as HBV DNA < 1 x 10(3) copies/ml, normal serum ALT, and HBeAg/HBsAg loss and seroconversion were analyzed at 26 weeks post-treatment.
  
  
  RESULTS
  A total of 54 patients (44 HBeAg positive, 10 HBeAg negative) were divided into two groups according to combination of bicyclol: treatment group (n = 20)--those who received combinition therapy with PEG-IFNalpha-2a +/- NUC and bicyclol, and control group (n = 34)--those who were treated with PEG-IFNalpha-2a +/- NUC antiviral monotherapy. During the first month of treatment, ALT levels declined gradually in treatment group. At 26 weeks post-treatment, the rates of ALT normalization and HBV DNA below the limit of 1 x 10(3) copies/ml were similar in both groups. Six patients in treatment group achieved HBsAg seroconversion at 26 weeks post-treatment, whereas so did 4 patients of control group (30% vs. 11.8%, P = 0.044).
  
  
  CONCLUSIONS
  Bicyclol could significantly relief elevation of ALT induced by the IFN treatment.
authors.affiliation: Department of Infectious Diseases, First Affiliated Hospital, College of Medicine, Zhejiang University, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Hangzhou, Zhejiang 310003, China.
authors.forename: Qin
authors.initials: Q
authors.lastname: Ni
authors.forename: Xie
authors.initials: X
authors.lastname: Tian-Sheng
authors.forename: Li
authors.initials: L
authors.lastname: Min-Wei
authors.forename: Liu
authors.initials: L
authors.lastname: Ke-Zhou
mesh_terms: D000410:Alanine Transaminase / Q000097:blood*; D001713:Biphenyl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D004279:DNA, Viral / Q000032:analysis; D004359:Drug Therapy, Combination; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D001713:Biphenyl Compounds; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C477843:bicyclol; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a