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Donor Deferral Recommendations for HIV Pre-exposure Prophylaxis

September 14, 2022

In December 2021, the U.S. FDA approved injectable cabotegravir (Apretude) as pre-exposure prophylaxis (PrEP) to prevent HIV transmission.  PrEP, post-exposure prophylaxis (PEP), and antiretroviral therapy (ART) medications are all essential to ending the HIV epidemic in the U.S.  Injectable cabotegravir may remain in circulation of some individuals for more than 17 months.  This long pharmacokinetic tail may mask a new HIV infection and pose a risk for false-negative HIV test results for blood donors.  While undetectable equals untransmittable (U=U) for sexual transmission of HIV, U=U may not apply to transfusion transmission because of the intravenous route of exposure and large volume of blood products infused.  Thus, the AABB recently published new updated donor deferral recommendations for injectable cabotegravir, which include deferring HIV-uninfected individuals for 2 years (instead for three months) after receiving the injectable cabotegravir as PrEP.  Unchanged recommendations include the 3-month deferral for oral cabotegravir use as PrEP and/or PEP and the indefinite deferral for individuals living with HIV and taking ART.  Donor history questionnaires (DHQ) should be updated with three direct questions about medications—one for oral PrEP and/or PEP, one for injectable PrEP, and one for ART.  The AABB has developed a toolkit and example documents for updating DHQs.

Reference:

AABB Association Bulletin #22-03.  Updated recommendations on donor deferral for use of antiretroviral medications for HIV prevention and treatment including long-acting injectable PrEP and the impact on blood safety.  September 8, 2022

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