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Recombinant human gamma-interferon in patients with chronic active hepatitis B: pharmacokinetics, tolerance and

P Marcellin1, M A Loriot, N Boyer

  • 1Service d'Hépatologie, Hôpital Beaujon, Clichy, France.

Hepatology (Baltimore, Md.)
|July 1, 1990
PubMed

Insights

Human recombinant gamma-interferon shows antiviral effects in chronic active hepatitis B patients. Subcutaneous injections are suitable, leading to decreased hepatitis B virus-DNA and HBeAg in some patients.

Area of Science:

  • Hepatology
  • Virology
  • Immunology

Background:

  • Chronic active hepatitis B is a significant global health concern.
  • Interferons are a class of cytokines with antiviral properties.
  • Recombinant gamma-interferon is a potential therapeutic agent.

Purpose of the Study:

  • To evaluate the pharmacokinetics, tolerance, and biological effects of human recombinant gamma-interferon in chronic active hepatitis B patients.
  • To assess the antiviral activity of recombinant gamma-interferon against hepatitis B virus (HBV).

Main Methods:

  • 12 patients with chronic active hepatitis B received recombinant gamma-interferon (2.5-10 million U daily) for 4 months.
  • Pharmacokinetics were assessed via radioimmunoassay in four patients after subcutaneous injection.
  • Biological effects were monitored by measuring serum ALT, HBV-DNA, and HBeAg levels.

Main Results:

  • Subcutaneous administration resulted in peak serum concentrations within 5-8 hours, detectable for 24-36 hours.
  • A dose-dependent, flu-like syndrome was observed in all patients.
  • Recombinant gamma-interferon induced a marked increase in serum ALT and a significant decrease in serum HBV-DNA.
  • HBV-DNA disappeared in one patient during treatment and in four additional patients post-treatment.
  • HBeAg disappeared in two patients during the 12-month follow-up period.

Conclusions:

  • Subcutaneous administration of recombinant gamma-interferon is suitable for chronic active hepatitis B.
  • Recombinant gamma-interferon demonstrates significant antiviral effects, including reduction of HBV-DNA and HBeAg.
  • Further investigation into recombinant gamma-interferon as a treatment for chronic hepatitis B is warranted.

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