Long term response to therapy of chronic anti-HBe-positive hepatitis B is poor independent of type and schedule of interferon

Am J Gastroenterol. 1999 May;94(5):1366-72. doi: 10.1111/j.1572-0241.1999.01088.x.


Objective: The response rate to alpha interferon (IFN) of chronic anti-HBe-positive hepatitis B is variable. We studied whether type, dose, and schedule of IFN, and type and frequency of posttreatment monitoring, influence the response rate.

Methods: Seventy-two consecutive anti-HBe-positive chronic hepatitis B patients (59 male and 13 female, median age 41 yr) stratified by sex and histology were randomly allocated to three treatment arms. Twenty-seven patients (A) received 10 million units alpha-N1 IFN i.m. t.w. for 24 wk (total dose: 720 million units); 21 (B) received 9 million units alpha-2a IFN i.m. t.w. for 4 wk, followed by 18 million units for 12 wk and 9 million units for 8 wk (972 million units); 24 (C) received 2 alpha-2a IFN courses (9 million units i.m. t.w. for 16 and 12 wk separated by a 6-month interval [756 million units]). Primary response was defined by normal ALT and serum HBV-DNA levels below 10 pg/ml at the end of therapy and sustained response by normal ALT (tested monthly), undetectable HBV-DNA and IgM anti-HBc (<7 I.U. Paul Ehrlich Institute) (tested every 3 months) during the posttreatment follow-up.

Results: At the end of treatment, 12, 8, and 13 patients from groups A, B, and C, respectively, were responders. At the 18-month follow-up, two patients in group A and only one in groups B and C maintained the response. Overall, after 34 months (median posttreatment follow-up), three patients were long term responders, whereas three showed a sustained remission after relapse.

Conclusions: The rate of long term response to interferon of anti-HBe-positive chronic hepatitis B is poor, independent of IFN type, dose, or schedule; the more stringent the monitoring, the higher the relapse rate.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Alanine Transaminase / blood
  • Antiviral Agents / administration & dosage*
  • Drug Administration Schedule
  • Female
  • Hepatitis B Antibodies / analysis*
  • Hepatitis B e Antigens / immunology*
  • Hepatitis B, Chronic / diagnosis
  • Hepatitis B, Chronic / immunology
  • Hepatitis B, Chronic / therapy*
  • Humans
  • Interferon Type I / administration & dosage
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage
  • Interferons / administration & dosage*
  • Liver / pathology
  • Male
  • Middle Aged
  • Recombinant Proteins
  • Recurrence
  • Treatment Outcome


  • Antiviral Agents
  • Hepatitis B Antibodies
  • Hepatitis B e Antigens
  • Interferon Type I
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Interferons
  • Alanine Transaminase