Abstract |
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.
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Authors | M C Rasch, H Schellekens, C M van Dijck, E B Haagsma, P P Michielsen, A H van Buuren, H Stötter, J van Hattum |
Journal | Digestive diseases and sciences
(Dig Dis Sci)
Vol. 43
Issue 8
Pg. 1719-24
(Aug 1998)
ISSN: 0163-2116 [Print] United States |
PMID | 9724159
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- DNA, Viral
- Hepatitis B Antibodies
- Hepatitis B Surface Antigens
- Hepatitis B e Antigens
- Interferon Type I
- Interferon-alpha
- Recombinant Proteins
- interferon-alpha B-D
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Topics |
- Adult
- DNA, Viral
(analysis)
- Female
- Hepatitis B Antibodies
(analysis)
- Hepatitis B Surface Antigens
(analysis)
- Hepatitis B e Antigens
(analysis)
- Hepatitis B virus
(isolation & purification)
- Hepatitis B, Chronic
(therapy, virology)
- Humans
- Interferon Type I
(administration & dosage, adverse effects)
- Interferon-alpha
- Male
- Middle Aged
- Recombinant Proteins
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