Reduction in transmission of hepatitis C after the introduction of a heat-treatment step in the production of C1-inhibitor concentrate.
BACKGROUND
The transmission of viral infections via protein concentrates made from a large pool of plasma depends on the selection of donors, fractionation process, and virucidal methods. To date, no data are available on the infectivity risk of plasma concentrates of the inhibitor of the first component of complement (C1-INH).


METHODS
The prevalence of blood-borne viral infections and levels of transaminases were evaluated in patients treated with a large-pool plasma concentrate of the inhibitor of C1-INH before and after the introduction of virucidal methods. The study included 85 patients with hereditary angioedema and 4 with acquired angioedema. The patients were divided into three groups: 1) 48 untreated patients; 2) 22 patients treated with non-virus-inactivated C1-INH concentrates; and 3) 19 patients treated with virus-inactivated concentrates. Serum samples obtained at various times after the infusion of concentrate were assayed for alanine amino-transferase and tested for hepatitis B surface antigen and antibodies to hepatitis C virus (anti-HCV) and human immunodeficiency virus (anti-HIV); anti-HCV-negative subjects exposed to the concentrate were also tested for HCV RNA.


RESULTS
Prevalences of HCV infection and elevated alanine aminotransferase are significantly lower in patients treated with virus-inactivated concentrates than in those exposed to non-virus-inactivated concentrates. No patients were anti-HIV positive.


CONCLUSIONS
This study suggests that C1-INH concentrates transmitted HCV, but that the virucidal methods adopted are effective in reducing the infectivity.
Cicardi
M
M
Institute of Internal Medicine, Maggiore Hospital, Milan, Italy.
Mannucci
P M
PM
Castelli
R
R
Rumi
M G
MG
Agostoni
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000799:Angioedema / Q000188:drug therapy; D003174:Complement C1 Inactivator Proteins / Q000627:therapeutic use*; D005260:Female; D015483:HIV Antibodies / Q000097:blood; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D006508:Hepatitis Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006526:Hepatitis C / Q000175:diagnosis / Q000517:prevention & control* / Q000635:transmission*; D006358:Hot Temperature; D006801:Humans; D008297:Male; D008875:Middle Aged; D010949:Plasma / Q000821:virology*; D012367:RNA, Viral / Q000097:blood
D003174:Complement C1 Inactivator Proteins; D015483:HIV Antibodies; D006508:Hepatitis Antibodies; D006514:Hepatitis B Surface Antigens; D012367:RNA, Viral; D000410:Alanine Transaminase