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Blood, 15 October 2001, Vol. 98, No. 8, pp. 2571-2573
BRIEF REPORT
TT virus contaminates first-generation recombinant factor
VIII concentrates
Alberta Azzi,
Riccardo De Santis,
Massimo Morfini,
Krystyna Zakrzewska,
Roberto Musso,
Elena Santagostino, and
Giancarlo Castaman
From the Public Health Department, Microbiology and
Virology Unit, University of Florence, Italy; the Hematology Department
and Hemophilia Center, Azienda Ospedaliera Careggi, Florence, Italy;
the Hematology Department and Hemophilia Center of Catania, Italy; the
A. Bianchi Bonomi Hemophilia Center, IRCCS Maggiore Hospital and
University of Milan, Italy; and the Hematology Department and
Hemophilia Center, San Bortolo Hospital, Vicenza, Italy.
Recombinant factor VIII and factor IX concentrates,
human-plasma-derived albumin, and samples from previously untreated
patients with hemophilia were examined for the presence of TT virus
(TTV) by using polymerase chain reaction testing. Blood samples from the patients were obtained prospectively before and every 3 to 6 months
after therapy was begun. TTV was detected in 23.5% of the
recombinant-product lots and 55.5% of the albumin lots tested. Only
first-generation factor VIII recombinant concentrates stabilized with
human albumin were positive for TTV, whereas all second-generation (human protein-free) concentrates were negative for the virus. In 59%
of patients treated with either first- or second-generation recombinant
factor concentrates, TTV infection developed at some point after the
initial infusion. Infection with TTV in these patients before and after
treatment did not appear to be clinically important. Thus,
first-generation recombinant factor VIII concentrates may contain TTV
and the source of the viral contamination may be human albumin.

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