Long-term follow-up of peginterferon and lamivudine combination treatment in HBeAg-positive chronic hepatitis B

Hepatology. 2005 Jun;41(6):1357-64. doi: 10.1002/hep.20695.

Abstract

We have previously demonstrated that combination peginterferon and lamivudine treatment has superior antiviral efficacy to lamivudine monotherapy in chronic hepatitis B. In this study, we investigated the long-term posttreatment virological response to this combination treatment. Sustained virological response of patients who completed 32-week peginterferon and 52-week lamivudine combination treatment was compared to patients who completed 52-week lamivudine monotherapy. Sustained response was defined as sustained hepatitis B e antigen (HBeAg) loss and HBV DNA < 100,000 copies/mL from treatment cessation until the end of follow-up. Forty-eight patients receiving combination treatment and 47 patients receiving lamivudine monotherapy were studied. The posttreatment follow-up of patients who received combination treatment was 117 +/- 34 weeks and that of patients receiving lamivudine monotherapy was 124 +/- 29 weeks. At the end of treatment, HBeAg loss occurred in 63% of patients in the combination group and 28% of patients in the lamivudine group (P = .001). The probabilities of sustained response for combination treatment and lamivudine monotherapy were 33% and 13% at week 24, 31% and 11% at week 52, and 29% and 9% at week 76, respectively (log-rank test, P = .0015). No patients developed virological relapse after week 76 until the last visit in either treatment group. All sustained responders had no biochemical relapse (alanine aminotransferase [ALT] > 2 times upper limit of normal) during follow-up. Among the non-sustained responders, biochemical relapse occurred in 32 patients (94%) in the combination group and 38 patients (88%) in the lamivudine group, respectively. In conclusion, combination treatment of peginterferon and lamivudine has a higher sustained virological response than lamivudine monotherapy up to 3 years after treatment.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • DNA, Viral / metabolism
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Gene Dosage
  • Hepatitis B e Antigens / blood*
  • Hepatitis B, Chronic / drug therapy*
  • Hepatitis B, Chronic / genetics
  • Hepatitis B, Chronic / immunology*
  • Hepatitis B, Chronic / virology
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage
  • Interferon-alpha / therapeutic use*
  • Lamivudine / administration & dosage
  • Lamivudine / therapeutic use*
  • Male
  • Polyethylene Glycols
  • Predictive Value of Tests
  • Prognosis
  • Recombinant Proteins
  • Recurrence
  • Reverse Transcriptase Inhibitors / administration & dosage
  • Reverse Transcriptase Inhibitors / therapeutic use*
  • Viral Load

Substances

  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B e Antigens
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Reverse Transcriptase Inhibitors
  • Lamivudine
  • Polyethylene Glycols
  • peginterferon alfa-2b