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Opinion regarding the exemption protocol for organ transplants between HIV-Positive donors and recipients

 The "HIV-positive-to-HIV-positive transplant" protocol, published as an annex to the Order of July 5, 2021, governing organ transplants between HIV-positive donors and recipients, is modeled on the HOPE Act (HIV Organ Policy Equity) protocol launched in the United States in 2016. That initiative aimed to expand transplant access for HIV-infected patients while ensuring their safety. Given the positive results of the US protocol published recently (2021–2026) and the encouraging results obtained in France, the French “Direction Générale de la Santé” (DGS) sought the opinion of the High Council for Public Health (HCSP) regarding various points raised by the expert group at the Biomedicine Agency (ABM) with the aim of revising the protocol and simplifying the recruitment of donors and recipients. After reviewing data collected by the ABM, recent literature, and practices in other countries, the HCSP has endorsed all the proposed modifications:

  • regarding inclusion criteria for deceased donors:
    • prioritize information confirming a viral load below the 50 copies/mL threshold at the time of donation over other previously required virological monitoring data, if the latter are unavailable;
    • authorize the inclusion of Maastricht category III donors (circulatory arrest following a decision to withdraw life-sustaining treatment);
    • eliminate routine liver biopsy;
  • regarding inclusion criteria for living donors, replace the former routine renal biopsy by an individual risk score based on a validated algorithm;
  • regarding inclusion criteria for recipients, redefine "well-controlled" infection based on the medical team's assessment ensuring the absence of recent treatment failure by using a viral load threshold of 200 copies/mL.

In addition, the HCSP:

  • recommends revising the Order of 13 July 2021 and incorporating the aforementioned modifications into the scientific and regulatory framework of a common protocol for exceptional organ transplants from donors infected with HIV or hepatitis B and C viruses;
  • encourages the implementation of multidisciplinary studies, modeled on the work conducted with the HOPE cohort in the USA, regarding organ transplants performed within France and Europe between HIV-positive individuals.

 

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