Transfusion Medicine Reviews
Volume 24, Issue 2 , Pages 151-152, April 2010

The Usefulness of Pathogen Inactivation During an Outbreak of the New Strain of Influenza (H1N1)

  • Hiroto Narimatsu

      Affiliations

    • Corresponding Author InformationAddress reprint requests to Hiroto Narimatsu, Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, the University of Tokyo 4-6-1, Shirogane-dai, Minato-ku, Tokyo, Japan 180-8649.
    • ,
  • Koichiro Yuji

Division of Social Communication System for Advanced Clinical Research, Institute of Medical Science, University of Tokyo, Tokyo, Japan

Division of Transfusion Medicine, Shinshu University Hospital, Matsumoto, Nagano, Japan

Division of Social Communication System for Advanced Clinical Research, Institute of Medical Science, University of Tokyo, Tokyo, Japan

Article Outline

 

To the Editor:

The degree of attention surrounding the pandemic of a new strain of influenza virus (H1N1) has posed major crisis management problems to health care workers worldwide. In the Kansai region of Japan, the number of blood donors has fallen by approximately 40%.1 This drop in blood donations has been due to an increase in the number of people unwilling to leave their homes as a result of being exposed to and the possible spread of this new strain of influenza.1 The World Health Organization predicted that the number of blood donors would decrease by 25% in the event of a widespread H1N1 virus outbreak, but the decrease in blood donation in Japan far exceeded this figure. This fact has fulfilled the previously predicted concern that blood transfusions could be significantly impaired in the event of a new strain influenza pandemic.2, 3 The impact on the availability of platelet transfusions has been particularly severe. This is because inventory adjustments are difficult because platelets are stored at room temperature and therefore can only be kept for a storage period of 4 days (the usual storage period for platelets used in Japan). If platelet transfusions cannot be provided, the treatment of patients with malignant tumors would become significantly limited.2, 3

Pathogen inactivation is a method of treating blood products that inactivates disease-causing agents such as viruses, bacteria, and protozoa by damaging their nucleic acids. In addition, this approach inactivates cytomegalovirus (CMV) and the Epstein-Barr virus (EBV); so it can also be expected to decrease the risk of the infection with such viruses after a hematopoietic transplantation.

Pathogen inactivation may thus be useful in the event of a state of emergency caused by a pandemic of the new strain of influenza. The main pathogen inactivation methods used for platelet preparations involve the use of either riboflavin4 or amotosalen-HCl (S-59).5 Pathogen inactivation using S-59 warrants particular mention, as this process may make it possible to extend the shelf life of platelet preparations from 4 days to up to 7 days. This is because this method is able to inhibit the bacterial proliferation that occurs while the platelet suspension is in storage.5 Thus, if platelet shelf life could be extended, it would become much easier to carry out the necessary inventory adjustments and to more effectively use the available platelet preparations, with limited wastage.

Pathogen inactivation using S-59 has been approved in 16 European Union and several Southeast Asian nations, and is currently undergoing review in China and South Korea. In the United States, Cerus Corporation (Concord, CA) has completed several phase III clinical trials and has made application to the US Food and Drug Administration.6 The US Food and Drug Administration has considered it necessary to thoroughly determine the absence of a cause and effect relationship between the pathogen inactivation of platelets and the occurrence of pulmonary adverse events before licensing its use in the United States.7

In Japan, the Japanese Red Cross Society (JRC), the organization that is in charge of human blood-related operations, is also considering introducing this platelet pathogen inactivation method, but is currently focusing on various health concerns relating to its use. 8 Nonetheless, the initiation of appropriate trials in Japan is not yet in sight. We do not agree with the position of the JRC because the safety profile of the pathogen inactivation of platelet products using amotosalen-HCl (S-59) is reported to be equal to that of traditional platelet transfusions.9, 10 To the best of our knowledge, safety-related differences in different countries or jurisdictions have not been observed. As far as we are aware, the JRC has not provided a sufficient explanation for not proceeding more effectively with examining these issues.

The effectiveness of pathogen inactivation has mainly been considered from the viewpoint of preventing transfusion-transmitted infections. However, it is now necessary to debate the effectiveness of pathogen inactivation from the standpoint of ensuring a stable supply of platelet and other blood products in Japan and elsewhere in the event of a severe crisis caused by the new strain of influenza outbreak. It is clear that new strain of influenza (H1N1) will reemerge after the autumn and winter so that a stable supply of blood products for transfusions will come under a considerable supply threat. The criteria used to conduct a risk-benefit assessment in such an emergency are different from those that would be done under normal conditions. It is therefore urgent that debate about these issues is initiated in geographic locations in which pathogen activation has not yet been introduced, including both Japan and the United States.

Back to Article Outline

References 

  1. Drastic decrease in Kansai region blood donations; "The need to curtail blood transfusions" say the Ministry of Health, Labor and Welfare; Medical Institutions; New Strain Influenza. Asahi Shinbun. 2009 May 23
  2. Zimrin AB, Hess JR. Planning for pandemic influenza: Effect of a pandemic on the supply and demand for blood products in the United States. Transfusion. 2007;47:1071–1079
  3. Pandemic flu: A national framework for responding to an influenza pandemic. [Home page on the internet]. 22 [cited 2009 July 7]; Available from http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_0807342007;
  4. Kumar V, Lockerbie O, Keil SD, et al. Riboflavin and UV-light based pathogen reduction: Extent and consequence of DNA damage at the molecular level. Photochem Photobiol. 2004;80:15–21
  5. Picker SM, Speer R, Gathof BS. Functional characteristics of buffy-coat PLTs photochemically treated with amotosalen-HCl for pathogen inactivation. Transfusion. 2004;44:320–329
  6. Home page of Cerus Corporation [Home page on the internet]. cited 2009 June 24 Available from http://www.cerus.com/index.cfm2009;
  7. Webert KE, Cserti CM, Hannon J, et al. Proceedings of a consensus conference: Pathogen inactivation-making decisions about new technologies. Transfus Med Rev. 2008;22:1–34
  8. 2007, 2008 Proceedings summary of the Pharmaceutical Affairs and Food Sanitation Council's Haematology Division Operation Committee/Safety Technology Investigation Council. [Home page on the inernet] 2008 [cited 2009 June 21]; Available from: http://www-bm.mhlw.go.jp/shingi/2008/12/dl/s1225-15p.pdf
  9. Osselaer JC, Messe N, Hervig T, et al. A prospective observational cohort safety study of 5106 platelet transfusions with components prepared with photochemical pathogen inactivation treatment. Transfusion. 2008;48:1061–1071
  10. Osselaer JC, Cazenave JP, Lambermont M, et al. An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment. Vox Sang. 2008;94:315–323

PII: S0887-7963(09)00125-4

doi:10.1016/j.tmrv.2009.12.001

Transfusion Medicine Reviews
Volume 24, Issue 2 , Pages 151-152, April 2010

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