Inactivation des pathogènes par le procédé Intercept® dans les concentrés plaquettaires : bilan de 3 ans de généralisation en France

Longitudinal analysis of annual national hemovigilance data to assess pathogen reduced platelet transfusion trends during conversion to routine universal clinical use and 7‐day storage

“…The decision to adopt amotosalen/UVA PCs as the national standard of care in 2017 was driven by a desire to reduce the number of transfusion‐transmitted bacterial infections (TTBI), improve PC safety during arbovirus epidemics (caused by e.g., West Nile Virus, Zika Virus, Chikungunya Virus, Dengue Virus), reduce risks associated with other transfusion‐transmitted infections (TTIs) including Human T‐Lymphocyte Virus (HTLV), Plasmodium species parasites (causative agent of malaria) and syphilis, and replace irradiation and cytomegalovirus (CMV) serology screening 2 . The final decision to implement amotosalen/UVA PCs nationally was based on a wide‐ranging evaluation by French health authorities of the risks and benefits associated with PR PCs 3 . This evaluation took into account clinical studies performed prior to and after amotosalen/UVA CE Mark approval in 2002, 4–11 and findings from the EFFIPAP randomized controlled clinical trial of PR PCs in France, which documented no difference between amotosalen/UVA PCs in platelet additive solution (PAS) and conventional PCs in PAS, which has been the primary PC suspension medium in France since 2014 12 .…”

“…Amotosalen/UVA PCs were introduced in France with a 5‐day shelf‐life. Storage was increased to 7‐days in May (CTSA) and July (EFS) of 2018 3 . France introduced optimized skin cleansing and initial blood diversion in the late 1990s and early 2000s but did not use bacterial culture to reduce the incidence of PC‐associated TTBIs prior to the conversion to 100% amotosalen/UVA PCs 23–26 …”

“…Storage was increased to 7-days in May (CTSA) and July (EFS) of 2018. 3 France introduced optimized skin cleansing and initial blood diversion in the late 1990s and early 2000s but did not use bacterial culture to reduce the incidence of PC-associated TTBIs prior to the conversion to 100% amotosalen/UVA PCs. [23][24][25][26] Labile blood components issued in France are tracked through a national electronic HV system established by law in 1993 and proactively managed by ANSM to meet traceability and adverse reaction reporting requirements under French law and the European Union (EU) Blood Directive.…”

“…2 The final decision to implement amotosalen/ UVA PCs nationally was based on a wide-ranging evaluation by French health authorities of the risks and benefits associated with PR PCs. 3 This evaluation took into account clinical studies performed prior to and after amotosalen/ UVA CE Mark approval in 2002, [4][5][6][7][8][9][10][11] and findings from the EFFIPAP randomized controlled clinical trial of PR PCs in France, which documented no difference between amotosalen/UVA PCs in platelet additive solution (PAS) and conventional PCs in PAS, which has been the primary PC suspension medium in France since 2014. 12 Authorities also reviewed assessments of amotosalen/UVA PC safety and performance compiled through multiple hemovigilance (HV) studies conducted by the manufacturer and other investigators in France 13 and other European countries [14][15][16][17][18] ; clinical experience with amotosalen/UVA PCs during a Chikungunya virus outbreak in an Indian Ocean island territory 19 ; population-based HV data collected in France by the Agence nationale de sécurité du medicament et des produits de santé (ANSM) (or, prior to 2011, its predecessor, AFSSAPS), and; real-world experience with amotosalen/UVA PCs from other European countries, including Switzerland, where amotosalen/UVA PCs have been the national standard since 2011, 20,21 and Belgium, which introduced PR in 2009 and converted to 100% amotosalen/UVA PCs in 2016.…”