title: Randomised clinical trial: efficacy of peginterferon alfa-2a in HBeAg positive chronic hepatitis B patients with lamivudine resistance.
abstract: BACKGROUND
  Previous studies suggested that a finite course of peginterferon alfa-2a may offer an alternative rescue therapy for patients with lamivudine resistance. However, because of the limitation of study design and small sample size, it is difficult to make definitive conclusion.
  
  
  OBJECTIVE
  To explore the role of peginterferon alfa-2a, in the rescue treatment of HBeAg-positive chronic hepatitis B patients with lamivudine resistance.
  
  
  METHODS
  In this randomised study, chronic hepatitis B patients with lamivudine resistance were treated with peginterferon alfa-2a for 48 weeks (n=155) or adefovir for 72 weeks (n=80). All enrolled patients were treated with lamivudine for the first 12weeks.
  
  
  RESULTS
  At 6 months posttreatment, 14.6% (18/123) of peginterferon alfa-2a-treated patients achieved HBeAg seroconversion, in contrast to 3.8% (3/80) of adefovir-treated patients after 72 weeks continuous therapy (P=0.01). For peginterferon alfa-2a-treated patients, the rate of HBeAg seroconversion at week 72 was significantly higher in patients who had HBsAg decline >0.5 Log(10) IU/mL from baseline at week 24, compared with patients with HBsAg decline ≤0.5 Log(10) IU/mL from baseline at week 24 (25.5% vs. 7.7%, P=0.01). After 72 weeks continuous adefovir treatment, 22.5% of patients achieved HBV DNA <80 IU/mL, compared with 10.6% in peginterferon alfa-2a-treated patients at 6months off-treatment (P=0.02).
  
  
  CONCLUSIONS
  Overall, the response to peginterferon alfa-2a among patients with lamivudine resistance was suboptimal. HBeAg seroconversion rate at week 72 by 48 weeks peginterferon alfa-2a treatment was higher than continuous adefovir therapy. Monitoring HBsAg levels can help to predict response to peginterferon alfa-2a.
authors.affiliation: Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: J
authors.initials: J
authors.lastname: Sun
authors.forename: J-L
authors.initials: JL
authors.lastname: Hou
authors.forename: Q
authors.initials: Q
authors.lastname: Xie
authors.forename: X-H
authors.initials: XH
authors.lastname: Li
authors.forename: J-M
authors.initials: JM
authors.lastname: Zhang
authors.forename: Y-M
authors.initials: YM
authors.lastname: Wang
authors.forename: H
authors.initials: H
authors.lastname: Wang
authors.forename: J-Y
authors.initials: JY
authors.lastname: Lai
authors.forename: S-J
authors.initials: SJ
authors.lastname: Chen
authors.forename: J-D
authors.initials: JD
authors.lastname: Jia
authors.forename: J-F
authors.initials: JF
authors.lastname: Sheng
authors.forename: H L Y
authors.initials: HL
authors.lastname: Chan
authors.forename: J-F
authors.initials: JF
authors.lastname: Wang
authors.forename: M K K
authors.initials: MK
authors.lastname: Li
authors.forename: M
authors.initials: M
authors.lastname: Jiang
authors.forename: M
authors.initials: M
authors.lastname: Popescu
authors.forename: J J Y
authors.initials: JJ
authors.lastname: Sung
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D002681:China; D024882:Drug Resistance, Viral / Q000187:drug effects*; D004359:Drug Therapy, Combination; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D063065:Organophosphonates; D011994:Recombinant Proteins; D019259:Lamivudine; D011092:Polyethylene Glycols; C053001:adefovir; D000225:Adenine; C100416:peginterferon alfa-2a