Two dose regimens of recombinant interferon-alpha-2b in chronic hepatitis C virus infection. Biochemistry, hepatitis C virus RNA, and liver histology as response indices.
BACKGROUND
Recombinant interferon remains the cornerstone of treatment of chronic hepatitis C virus (HCV) infection. Still, evaluation of treatment on the basis of response indicators and long-term effect of the treatment raises several questions.


METHODS
Seventy-four patients with chronic HCV infection were randomized to a high (3 MIU, 3/7 days) or low (1 MIU, 3/7 days) dose of recombinant interferon-alpha-2b for 48 weeks after a 4-week course of 3 MIU, 3/7 days. Response to treatment was assessed by means of liver enzymes (transaminases), HCV RNA, and liver histology.


RESULTS
The higher maintenance dose was associated with a significantly higher rate of sustained alanine aminotransferase (ALAT) response (45% versus 19%) and with a significantly better chance of becoming HCV RNA-negative during therapy (47% versus 23%). In the high maintenance dose group 14 of the 29 (48%) patients with available HCV RNA data were negative at the 3-month follow-up, compared with 4 of 27 (15%) in the low maintenance dose group. Significantly more patients had improved liver biopsy findings after interferon in the high maintenance dose group (79%) than in the low maintenance dose group (36%). There was a close correlation between ALAT response and HCV RNA response. Of 17 patients who were HCV RNA-negative 3 months after the end of treatment, 10 remained HCV RNA-negative 2-4 years later.


CONCLUSIONS
The study demonstrates a higher response rate as assessed by biochemistry, HCV RNA, and liver histology in the higher dose group.
Bjøro
K
K
Medical Dept. A, Rikshospitalet, Oslo, Norway.
Krarup
H
H
Bell
H
H
Christophersen
P
P
Evensen
S
S
Frøland
S S
SS
Laursen
A
A
B vd Lippe
B
B
Maeland
A
A
Ranek
L
L
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D001483:Base Sequence; D002908:Chronic Disease; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000201:enzymology / Q000473:pathology / Q000628:therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins / Q000008:administration & dosage; D000637:Transaminases / Q000097:blood; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D000637:Transaminases