title: Hepatitis B surface antigen levels: association with 5-year response to peginterferon alfa-2a in hepatitis B e-antigen-negative patients.
abstract: OBJECTIVE
  To investigate the durability of response to peginterferon alfa-2a up to 5 years post-treatment and factors associated with response in hepatitis B e-antigen (HBeAg)-negative patients.
  
  
  METHODS
  HBeAg-negative patients received peginterferon alfa-2a (180 μg/week) ± lamivudine (100 mg/day) for 48 weeks as part of a multicenter, randomized study. The planned 5-year efficacy analysis included patients (n = 230) enrolled in the long-term follow-up study. On-treatment hepatitis B surface antigen (HBsAg) decline kinetics were analyzed retrospectively in a subgroup of patients with HBsAg data available at baseline, weeks 12, 24, and 48 on-treatment, and 6 months post-treatment (n = 120). Receiver operating characteristic analyses identified the on-treatment HBsAg levels associated with response at 1 and 5 years post-treatment.
  
  
  RESULTS
  HBV DNA ≤2,000 IU/mL and HBsAg clearance at 5 years post-treatment were achieved by 23 and 12% of patients, respectively. High rates of HBsAg clearance at 5 years post-treatment were achieved by patients with HBV DNA ≤2,000 IU/mL at 1 year post-treatment (28%). Rates of HBV DNA ≤2,000 IU/mL at 1 year post-treatment were 47.2 and 43.4% in patients with ≥10% decline from baseline at weeks 12 and 24, respectively, compared with 16.4% (p = 0.0003) and 13.2% (p < 0.0004) in patients with a <10% decline. Rates of HBsAg clearance at 5 years post-treatment were 22.6 and 22.4% in patients with ≥10% decline at weeks 12 and 24, respectively, compared with 7.5% (p = 0.0161) and 3.8% (p < 0.0001) in patients with <10% decline.
  
  
  CONCLUSIONS
  Peginterferon alfa-2a results in increasing rates of HBsAg clearance during post-treatment follow-up in HBeAg-negative patients. On-treatment decline in HBsAg is significantly associated with long-term post-treatment response.
authors.affiliation: Service d'Hépatologie and INSERM U773-CRB3, Hôpital Beaujon, University of Paris, 100 boulevard du Général Leclerc, 92110 Clichy, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Bonino
authors.forename: Cihan
authors.initials: C
authors.lastname: Yurdaydin
authors.forename: Stephanos
authors.initials: S
authors.lastname: Hadziyannis
authors.forename: Rami
authors.initials: R
authors.lastname: Moucari
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Kapprell
authors.forename: Vivien
authors.initials: V
authors.lastname: Rothe
authors.forename: Matei
authors.initials: M
authors.lastname: Popescu
authors.forename: Maurizia R
authors.initials: MR
authors.lastname: Brunetto
keywords: Chronic hepatitis B; HBV DNA suppression; HBsAg clearance; Long-term response; Prediction