title: Recombinant human gamma-interferon in patients with chronic active hepatitis B: pharmacokinetics, tolerance and biological effects.
abstract: Pharmacokinetics, tolerance and biological effects of human recombinant gamma-interferon were studied in 12 patients with chronic active hepatitis B. Serum concentrations of gamma-interferon were measured by radioimmunoassay in four patients after a subcutaneous injection of 10 million U (0.5 mg); the peak serum concentration of gamma-interferon (29 +/- 7 U/ml) was reached after 5 to 8 hr and gamma-interferon remained detectable for 24 to 36 hr. Twelve patients received recombinant gamma-interferon, 2.5 to 10 million U daily, for 4 mo. All suffered from a dose-dependent, flulike syndrome similar to that induced by alpha-interferon. Recombinant gamma-interferon induced a marked increase of serum ALT and a significant decrease of serum hepatitis B virus-DNA. Serum hepatitis B virus-DNA disappeared in one patient during administration of recombinant gamma-interferon. Serum hepatitis B virus-DNA disappeared in four additional patients, and HBeAg disappeared in two patients during the 12 mo after administration of recombinant gamma-interferon. These results indicate that subcutaneous injection is suitable for administration of recombinant gamma-interferon and that recombinant gamma-interferon has an antiviral effect in patients with chronic active hepatitis B.
authors.affiliation: Service d'Hépatologie, Hôpital Beaujon, Clichy, France.
authors.forename: P
authors.initials: P
authors.lastname: Marcellin
authors.forename: M A
authors.initials: MA
authors.lastname: Loriot
authors.forename: N
authors.initials: N
authors.lastname: Boyer
authors.forename: M
authors.initials: M
authors.lastname: Martinot-Peignoux
authors.forename: C
authors.initials: C
authors.lastname: Degott
authors.forename: F
authors.initials: F
authors.lastname: Degos
authors.forename: M
authors.initials: M
authors.lastname: Brandely
authors.forename: B
authors.initials: B
authors.lastname: Lenfant
authors.forename: J P
authors.initials: JP
authors.lastname: Benhamou
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D004279:DNA, Viral / Q000032:analysis; D006509:Hepatitis B / Q000628:therapy*; D006513:Hepatitis B e Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007371:Interferon-gamma / Q000187:drug effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D011994:Recombinant Proteins
chemical_list: D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D011994:Recombinant Proteins; D007371:Interferon-gamma; D000410:Alanine Transaminase