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Proposals for changing the scientific framework relating to the conditions of use, particularly on an exceptional basis, of organs and tissues from donors carrying markers of infection by hepatitis B (HBV) and C (HCV) viruses

In 2023, the French Biomedicine Agency (ABM) developed proposals for changing the scientific framework relating to the conditions of use, particularly on an exceptional basis, of organs and tissues from donors carrying certain markers of infection by hepatitis B (HBV) and C (HCV) viruses. These proposals constitute the outcome of recommendations elaborated since 2016 in close collaboration with a college of experts in exceptional transplants and learned societies specialized in hepatology and transplantation. The French High Council of Public Health (HCSP) approves in their entirety the measures proposed by ABM which aim to extend the possibility of exceptional transplants for HBV and HCV in the interest of transplant candidates, taking into account the current possibilities for detecting infections, the available therapeutic means and the favorable benefit-risk ratio: (i) for HCV, the HCSP proposes notably to expand the eligible circle of organ recipients from donors seropositive for HCV but not viremic (profile of cured HCV infection) to all organ recipients, whether their HCV serology is positive or negative, eliminating the notion of vital emergency; (ii) for HBV, the HCSP authorizes the collection of kidneys from deceased donors positive for HBs antigen and/or with a positive HBV DNAmia in order to offer them to recipients awaiting renal or renal-pancreatic transplant, who are informed and consent, already positive for the HBs antigen and/or viremic, provided that they receive treatment with anti-HBV antivirals for the entire duration of their transplant; (iii) for both viruses, the HCSP also makes donors who died after circulatory arrest in category 3 of the Maastricht classification eligible for these “exceptional” transplants. With regard to tissues, the HCSP recommends that the development proposals concerning HBV and HCV be extended to all the tissues not explicitly mentioned in previous recommendations, including notably veins and placental tissues. For these same agents, the HCSP proposes improvements for donations of hematopoietic stem cells and mononuclear cells. Finally, the HCSP acknowledges simplification of legislative texts by limiting their content to the main guidelines and by moving all the technical considerations towards rules of good practice submitted to the approbation of the HCSP.

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