Recombinant Human γ–Interferon in Patients With Chronic Active Hepatitis B: Pharmacokinetics, Tolerance and Biological Effects

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Abstract
Pharmacokinetics, tolerance and biological effects of human recombinant γ–interferon were studied in 12 patients with chronic active hepatitis B. Serum concentrations of γ–interferon were measured by radioimmunoassay in four patients after a subcutaneous injection of 10 million U (0.5 mg); the peak serum concentration of γ–interferon (29 ± 7 U/ml) was reached after 5 to 8 hr and γ–interferon remained detectable for 24 to 36 hr. Twelve patients received recombinant γ–interferon, 2.5 to 10 million U daily, for 4 mo. All suffered from a dose–dependent, flulike syndrome similar to that induced by α–interferon. Recombinant γ–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 γ–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 γ–interferon. These results indicate that subcutaneous injection is suitable for administration of recombinant γ–interferon and that recombinant γ–interferon has an antiviral effect in patients with chronic active hepatitis B. (Hepatology 1990;12:155-158).