Transfusion-associated chronic hepatitis C: alpha-n1 interferon for 6 vs. 12 months.
OBJECTIVE
To compare the long-term effects of brief and prolonged therapy with alpha-n1 interferon for transfusion-associated chronic hepatitis C.


METHODS
One hundred and sixteen subjects (male/female 48/68, mean age 46.9 years) were studied. Sixty patients were randomised to brief treatment (group 1: interferon 5 Mu/msq. t.i.w. for 2 months, then 3 Mu/msq. t.i.w. for 4 months), and 56 to prolonged treatment (group 2: interferon 5 Mu/msq. t.i.w. for 2 months, then 3 Mu/msq. t.i.w. for 10 months). All were followed for 12 months after stopping interferon.


RESULTS
The early response rate was 47.4% (Group 1 [45%], Group 2[50%]. No "breakthrough" reactivations were observed. The early response rate was 19% in patients with and 63% in patients without cirrhosis. Twenty-three (19.8%) subjects stopped therapy. Among 54 evaluable early responders, 21 had a sustained response. The rate of sustained response was comparable in group 1 (18.3%) and group 2 (18.2%). All sustained response subjects and some non-responders were HCV-RNA negative at the end of follow-up. Histological improvement was seen only after sustained response. Cirrhosis developed in 20% of non-responders. Overall, interferon induced a long-lasting remission of chronic hepatitis C in about one of every five patients.


CONCLUSIONS
In a population predominantly infected by hepatitis C virus type 1, 12 months of therapy with high doses of interferon does not confer any additional benefit on the early response or sustained response rates as compared to a 6-month course.
Craxì
A
A
Instituto di Medicina Generale e Pneumologia, University of Palermo, Italy.
Di Marco
V
V
Lo Iacono
O
O
Almasio
P
P
Bruno
R
R
Cammà
C
C
Volpes
R
R
Pagliaro
L
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000906:Antibodies / Q000097:blood; D002908:Chronic Disease; D004334:Drug Administration Schedule; D005260:Female; D006526:Hepatitis C / Q000635:transmission*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D065227:Transfusion Reaction
D000906:Antibodies; D016898:Interferon-alpha