Tolerance and Antiviral Effects of High-Dose Interferon-α B/D in Patients with Chronic Hepatitis B
A novel recombinant interferon-α B/Dhybrid was applied to assess tolerability, antiviraleffect, and biological activity in chronic hepatitis B.The study was designed as an open nonrandomized trial. Treatment comprised a two-week run-in phasewith 16 MU three times a week followed by 14 weeks with64 MU three times a week (or 48 MU if toxicity occurredwith 64 MU). Total follow-up was 36 weeks. Nineteen patients were included; three discontinuedtreatment during the run-in with 16 MU. Fourteen of 16patients had 14 weeks of treatment with ≥32 MU threetimes a week. Fourteen dose reductions were necessary in nine patients. The adverse experienceprofile was similar to other interferon-αs.HBV-DNA decreased using all doses studied. HBV-DNAbecame undetectable in five patients, two of whom hadHBeAg seroconversion. No HBsAg seroconversion was observed. It isconcluded that interferon-α B/D is well toleratedin high doses. The anti-viral effect starts at at least16 MU three times a week.