TT virus contaminates first-generation recombinant factor VIII concentrates

Alberta Azzi, Riccardo De Santis, Massimo Morfini, Krystyna Zakrzewska, Roberta Musso, Elena Santagostino, Giancarlo Castaman

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)2571-2573
Number of pages3
JournalBlood
Volume98
Issue number8
DOIs
Publication statusPublished - Oct 15 2001

ASJC Scopus subject areas

  • Hematology

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