Prediction of off-treatment response to lamivudine by serum hepatitis B surface antigen quantification in hepatitis B e antigen-negative patients

Antivir Ther. 2011;16(8):1249-57. doi: 10.3851/IMP1921.

Abstract

Background: The timing of antiviral therapy cessation in hepatitis B e antigen (HBeAg)-negative patients is controversial. Here, we aimed to investigate the role of HBV DNA and hepatitis B surface antigen (HBsAg) monitoring to predict off-treatment sustained response.

Methods: A total of 53 HBeAg-negative chronic hepatitis B patients who received lamivudine for 34 ±23 (range 12-76) months and had lamivudine stopped for 47 ±35 months were studied. Primary outcome was sustained response, defined as HBV DNA≤200 IU/ml, at 12 months post-treatment (SR-12).

Results: A total of 9 (17%) patients achieved SR-12. HBV DNA at baseline, month 6 and end of treatment had no association with SR-12. HBsAg levels tended to decrease more significantly during treatment among SR-12 responders. At the end of treatment, both HBsAg ≤2 log IU/ml and reduction by >1 log from baseline had sensitivity, specificity, positive and negative predictive values for SR-12 of 78%, 96%, 78% and 96%, respectively. All 5 patients with HBsAg≤2 log IU/ml and reduction >1 log at the end of treatment achieved SR-12 and all 40 patients with HBsAg>2 log IU/ml and reduction ≤1 log did not have SR-12. The cumulative probability of sustained response and HBsAg clearance at 5 years among patients with HBsAg≤2 log IU/ml were 88% and 72%, respectively, that among patients with HBsAg reduction >1 log were 74% and 61%, respectively.

Conclusions: Monitoring of HBsAg level can guide the timing of stopping lamivudine in HBeAg-negative chronic hepatitis B.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • DNA, Viral / blood
  • DNA, Viral / immunology
  • Female
  • Hepatitis B Surface Antigens / blood*
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B e Antigens / blood*
  • Hepatitis B e Antigens / immunology
  • Hepatitis B virus / drug effects*
  • Hepatitis B virus / immunology
  • Hepatitis B, Chronic / blood
  • Hepatitis B, Chronic / diagnosis*
  • Hepatitis B, Chronic / drug therapy
  • Hepatitis B, Chronic / immunology
  • Hepatitis B, Chronic / virology
  • Hong Kong
  • Humans
  • Interferon-alpha / administration & dosage
  • Interferon-alpha / therapeutic use
  • Lamivudine / administration & dosage
  • Lamivudine / therapeutic use
  • Male
  • Middle Aged
  • Polyethylene Glycols / administration & dosage
  • Polyethylene Glycols / therapeutic use
  • Predictive Value of Tests
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use
  • Retrospective Studies
  • Treatment Outcome
  • Withholding Treatment

Substances

  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens
  • Interferon-alpha
  • Recombinant Proteins
  • Lamivudine
  • Polyethylene Glycols
  • peginterferon alfa-2a