title: Predictive factors for sustained response to interferon treatment in patients with chronic hepatitis C: a randomized, open, and multi-center controlled trial.
abstract: BACKGROUND
  This study was undertaken to investigate the predictive factors of sustained viral response in roferon-A or pegasys treated chronic hepatitis C patients after logistic regression analysis of the factors that might be associated with the therapeutic effects of interferon (IFN).
  
  
  METHODS
  All patients enrolled into this randomized, open and multi-center controlled trial were divided into two groups randomly and treated with pegasys and roferon-A for 24 weeks, then followed up for another 24 weeks. Before treatment, hepatitis C virus (HCV) genotype was determined, and HCV-RNA in serum was detected before and at the end of treatment and follow-up. HCV-RNA turning negative was considered the major index for evaluating the therapeutic effect. The clinical characteristics including gender, age, infection route of HCV, treatment with IFN, platelet count, AST/ALT ratio and treatment drugs were analyzed by logistic regression.
  
  
  RESULTS
  Intention to treat (ITT) and per-protocol (PP) population groups have 208 and 197 patients respectively. In the PP group, after treatment for 24 weeks, the response rates of female patients aged less than 50 years, infected through non-transfusion, relapsed after IFN treatment, and presented with a AST/ALT ratio</=1, virus load less than 8 x 10(5) IU/ml, and non genotype 1 HCV infection, and treated finally with pegasys were higher than those of male patients, aged more than 50 years, infected by transfusion, treated firstly with IFN, presented with a AST/ALT ratio>/=1, virus load equal or more than 8 x 10(5) IU/ml, and genotype 1 infection, and treated finally with roferon-A. But, at the end of follow-up, the patients with a AST/ALT ratio>/=1 and virus load more than 8 x 10(5) IU/ml had a higher rate of sustained response than did those with a AST/ALT ratio</=1 and virus load less than 8 x 10(5) IU/ml. Logistic regression analysis and control of the promiscuous factors showed that the genotype of HCV was not related to the response rate at the end of treatment (OR 0.604, 95% CI 0.271-1.349, P=0.219), but was the independent predictive factor of virus sustained response to IFN treatment (OR 0.408, 95% CI 0.189-0.881, P=0.023). The form of IFN was significantly related to viral response at the end of treatment (OR 0.105, 95% CI 0.052-0.212, P<0.001), and pegasys were an intensely predictive factor for sustained response(OR 0.255, 95% CI 0.123-0.529, P<0.001).
  
  
  CONCLUSIONS
  HCV genotype and pegasys are the predictive factors for IFN response to the IFN treatment of patients with chronic hepatitis C.
authors.affiliation: Ninth Clinical Department, Beijing Ditan Hospital, Beijing 100011, China. xieyao@public.bta.net.cn
authors.forename: Yao
authors.initials: Y
authors.lastname: Xie
authors.forename: Dao-Zhen
authors.initials: DZ
authors.lastname: Xu
authors.forename: Zhi-Meng
authors.initials: ZM
authors.lastname: Lu
authors.forename: Kang-Xian
authors.initials: KX
authors.lastname: Luo
authors.forename: Ji-Dong
authors.initials: JD
authors.lastname: Jia
authors.forename: Yu-Ming
authors.initials: YM
authors.lastname: Wang
authors.forename: Gui-Zhen
authors.initials: GZ
authors.lastname: Zhao
authors.forename: Shu-Lin
authors.initials: SL
authors.lastname: Zhang
authors.forename: Da-Zhi
authors.initials: DZ
authors.lastname: Zhang
mesh_terms: D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D024882:Drug Resistance, Viral; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D018937:Hepatitis C Antibodies / Q000187:drug effects / Q000276:immunology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010597:Pharmacogenetics; D011092:Polyethylene Glycols; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D012016:Reference Values; D018570:Risk Assessment; D016037:Single-Blind Method; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D018937:Hepatitis C Antibodies; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b