Transfusion‐transmitted virus is not present in factor IX concentrates commonly used to treat haemophilia B

Abstract

Transfusion-transmitted virus (TTV) is a potential cause of post-transfusion hepatitis in patients with haemophilia. Plasma-derived clotting factor concentrates currently undergo processes that are effective in removal and inactivation of viruses such as HIV, hepatitis B and C; however, their effectiveness with respect to TTV is unknown. To determine if TTV DNA is present in plasma-derived concentrates of factor IX, we tested 14 lots of Mononine and compared the results with BeneFix. Nucleic acid isolation, followed by a two-round polymerase chain reaction (PCR) and agarose gel analysis indicated that all 17 lots were negative for TTV. Although TTV may be considered an emerging pathogen, no evidence of the virus was detected in the commercially available plasma-derived concentrate of FIX most commonly used to treat haemophilia B.

Torque teno virus among dialysis and renal-transplant patients

“…The modes of transmission are incompletely understood and are widely discussed in the literature. Parenteral transmission is an important propagation route ( Nishizawa et al , 1997 ), but the virus can also be transmitted by blood transfusion ( Oza et al , 2004 ) and by blood derivatives ( Barril et al , 2004 ). Other routes have been identified, including sexual ( Krekulova et al , 2001 ; Saláková et al , 2009 ), vertical ( Iso et al , 2001 ; Bagaglio et al , 2002 ), and fecal-oral ( Leary et al , 1999 ; Griffin et al , 2008 ).…”

Deep viral metagenomics in patients with haemophilia receiving plasma‐derived coagulation factor concentrates

“…On the other hand, it seems that in plasma-derived coagulation factors, TTV remains undetectable. 9 This may suggest that TTV infection might be acquired by different transmission routes among haemophiliacs compared to blood donors, where the non-parenteral transmission might be plausible for the higher TTV presence. Such routes might not show the same efficiency in haemophiliacs and this may lead to lower TTV abundance; however, such a hypothesis needs careful examination including in-depth comparative analysis of the TTV genotype viral loads among haemophilic patients and blood donors.…”

Blood safety and the choice of anti‐hemophilic factor concentrate

“…On the other hand, the second-generation factor VIII product Refacto and recombinant factor IX (Benefix) did not contain TTV. Recently, the most common factor IX products, Mononine and Benefix, used to treat hemophilia B were shown not to contain TTV [50].…”