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 hepatitis B. The study was designed as an open nonrandomized trial. Treatment comprised a two-week run-in phase with 16 MU three times a week followed by 14 weeks with 64 MU three times a week (or 48 MU if toxicity occurred with 64 MU). Total follow-up was 36 weeks. Nineteen patients were included; three discontinued treatment during the run-in with 16 MU. Fourteen of 16 patients had 14 weeks of treatment with > or = 32 MU three times a week. Fourteen dose reductions were necessary in nine patients. The adverse experience profile was similar to other interferon-alphas. HBV-DNA decreased using all doses studied. HBV-DNA became undetectable in five patients, two of whom had HBeAg seroconversion. No HBsAg seroconversion was observed. It is concluded that interferon-alpha B/D is well tolerated in high doses. The anti-viral effect starts at at least 16 MU three times a week.
Department of Gastroenterology, University Hospital Utrecht, The Netherlands.
M C
MC
Rasch
H
H
Schellekens
C M
CM
van Dijck
E B
EB
Haagsma
P P
PP
Michielsen
A H
AH
van Buuren
H
H
Stötter
J
J
van Hattum
D000328:Adult; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006510:Hepatitis B Antibodies / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006513:Hepatitis B e Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000628:therapy* / Q000821:virology; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage* / Q000009:adverse effects; D016898:Interferon-alpha; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins
D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D007370:Interferon Type I; D016898:Interferon-alpha; D011994:Recombinant Proteins; C114167:interferon-alpha B-D