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Referral related to prevention measures to be taken due to the risk of transmission of hepatitis E virus (HEV) from donors of products or elements of the human body

The implementation of systematic screening for the hepatitis E virus (HEV) by viral genomic diagnosis (VGD) became effective in France in March 2023 for all blood donations. This led the General Direction of Health (DGS) to ask the High Council for Public Health (HCSP) to assess the rules for deferring blood donors as well as the haemovigilance approach associated with the generalization of HEV DGV. On this occasion, the DGS also wanted the HCSP to study the opportunity to extend this screening to donations of tissues, cells and other products or elements of the human body.

With regard to labile blood products (LBP), the HCSP approves the procedures for setting up HEV DGV in donors by the French Blood Establishment (EFS) and the Armed Forces Health Transfusion Center (CTSA) ; it indicates the circumstances in which haemovigilance surveys must be carried out, under the supervision of the National Reference Center (CNR) for Hepatitis A and E: top-down investigation when HEV viremia is discovered in a donor and bottom-up investigation in case of discovery of a recent HEV infection in a recipient. Finally, it recommends that LBP donors who screen positive for HEV genome and contact cases be excluded from donation for 4 months.

In terms of tissue, organ or cell donations, the HCSP issues the following recommendations:

  • not setting up a systematic HEV DGV for tissue donations;
  • carry out, as far as possible, plasma detection of HEV RNA before donation for living donors of organs and hematopoietic stem cells (HSC), taking into account the benefit-risk ratio of the transplant in the event of positive result if the latter cannot be postponed until the donor is cured;
  • carry out, as far as possible, plasma detection of HEV RNA before donation in deceased organ donors; if this is not possible, the test can be carried out immediately after the transplant (48 hours excluding weekends) on the serum taken before the transplantation, with communication of the result without delay to the transplant team with the aim of implementing reinforced monitoring of the recipient(s).
  • do not carry out any HEV DGV for gamete and embryo donors in the context of medically assisted procreation.

In support of its recommendations, the HCSP proposes three decision-making algorithms on the HEV risk management strategy: in LBP donors, in living HSC and organ donors, and in deceased organ donors.

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