Hepatitis C viral RNA in clotting factor concentrates and the development
of hepatitis in recipients
M Makris, JA Garson, CJ Ring, PW Tuke, RS Tedder and FE Preston
Department of Haematology, Royal Hallamshire Hospital, Sheffield, UK.
The polymerase chain reaction (PCR) was used to detect hepatitis C (HCV)
viral sequences (HCV-RNA) in clotting factor concentrates that had been
stored at 4 degrees C for 1 to 16 years. A total of 43 concentrates were
tested, comprising 31 batches of factor VIII, 6 of factor IX, 2 of
antithrombin III, 3 of FEIBA, and 1 of factor VII. HCV- RNA was detected in
13 of the 43 batches (30.2%). Concentrates that had not undergone viral
inactivation during manufacture were significantly more likely to contain
detectable HCV-RNA than concentrates that had been virally inactivated
(56.3% v 14.5%, P = .006). HCV sequences were more commonly detected in
concentrates made from paid donor plasma than in those made from volunteer
donor plasma (44% v 11%, P = .041), and more commonly in virally
inactivated concentrates with pre-1989 than with post-1989 expiration dates
(50% v 0%, P = .004). Of the four batches of heat-treated products that
were HCV-RNA positive, at least three transmitted non-A, non-B hepatitis
(NANBH). An association between the presence of HCV-RNA in concentrates and
the development of NANBH was demonstrated in nine previously untreated
patients on prospective follow-up. HCV-RNA was detected in the concentrates
administered to the six patients whose alanine aminotransferase (ALT)
abnormalities met the diagnostic criteria for NANBH and who later
seroconverted for HCV, but it was not detected in the concentrates
administered to the three patients whose ALT abnormalities failed to
satisfy the diagnostic criteria and who did not seroconvert. We suggest
that the use of this PCR technique to monitor clotting factor concentrates
derived from pooled blood may potentially contribute to product safety.
Volume 81,
Issue 7,
pp. 1898-1902,
04/01/1993
Copyright © 1993 by The American Society of Hematology