4.6 Article

Hepatitis B surface antigen levels: association with 5-year response to peginterferon alfa-2a in hepatitis B e-antigen-negative patients

Journal

HEPATOLOGY INTERNATIONAL
Volume 7, Issue 1, Pages 88-97

Publisher

SPRINGER
DOI: 10.1007/s12072-012-9343-x

Keywords

Chronic hepatitis B; HBsAg clearance; HBV DNA suppression; Long-term response; Prediction

Funding

  1. F. Hoffmann-La Roche, Basel, Switzerland

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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. HBeAg-negative patients received peginterferon alfa-2a (180 mu g/week) +/- A 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. HBV DNA a parts per thousand currency sign2,000 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 a parts per thousand currency sign2,000 IU/mL at 1 year post-treatment (28%). Rates of HBV DNA a parts per thousand currency sign2,000 IU/mL at 1 year post-treatment were 47.2 and 43.4% in patients with a parts per thousand yen10% 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 a parts per thousand yen10% 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. 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.

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