Date du document : 25/11/2025
Date de mise en ligne : 15/12/2025
Since March 16, 2022, there has been a temporary contraindication to blood donation for blood donors who have received oral pre-exposure prophylaxis (PrEP) for the human immunodeficiency virus (HIV) within the past four months. In recent months, two injectable PrEP formulations, not yet marketed in France, have been authorized in the European Union: one based on cabotegravir and the other on lenacapavir. In the USA, the Food and Drug Administration, in view of the long half-life of these molecules, recommended a two-year deferral period, a period adopted by the European Centre for Prevention and Disease Control in its guidelines of September 29, 2025. This caution is also related to the potential ability of injectable antiretrovirals, in particular cabotegravir, to disrupt virological tests and delay the diagnosis of primary infection, a phenomenon known as "long acting early viral inhibition" or LEVI. Although the diagnostic strategy adopted in France for blood donations, which combines donor selection, combination of high-performance individual serological and genomic tests on each donation, and hemovigilance monitoring, appears capable of significantly reducing the diagnostic difficulties reported in the trials mentioned under the name LEVI, a large number of unknowns remain, including the long-term interindividual pharmacokinetic variability of injected molecules that can persist in the body for up to 25 months after the last injection, and the risk of selecting HIV-resistant mutants. Therefore, pending the development of epidemiological data and more robust scientific knowledge on the subject, the High Council for Public Health recommends (i) adapting the pre-donation questionnaire by introducing an item for donor candidates who have received injectable PrEP, taking care to identify and differentiate them from candidates on oral PrEP, and (ii) deferring donor candidates for two years after the last PrEP injection for the two aforementioned molecules soon to be available in France, with the mention of being able to revisit this period depending on the future of injectable PrEP strategies for the prevention of HIV infection.
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