TOLERANCE AND ANTIVIRAL EFFECTS OF HIGH-DOSE INTERFERON-ALPHA B D IN PATIENTS WITH CHRONIC HEPATITIS-B/

A novel recombinant interferon-alpha B/D hybrid was applied to assess tolerability, antiviral effect, and biological activity in chronic hep atitis B. The study was designed as an open nonrandomized trial. Treat ment comprised a two-week run-in phase with 16 MU three times a week f ollowed by 14 weeks with 64 MU three times a week (or 48 MU if toxicit y occurred with 64 MU). Total follow-up was 36 weeks. Nineteen patient s were included; three discontinued treatment during the run-in with 1 6 MU. Fourteen of 16 patients had 14 weeks of treatment with greater t han or equal to 32 MU three times a week. Fourteen dose reductions wer e necessary in nine patients. The adverse experience profile was simil ar to other interferon-alpha s. HBV-DNA decreased using all doses stud ied. HBV-DNA became undetectable in five patients, two of whom had HBe Ag seroconversion. No HBsAg seroconversion was observed. It is conclud ed that interferon-alpha BID is well tolerated in high doses. The anti -viral effect starts at at least 16 MU three times a week.