Association Bulletin #22-03 Outlines Updated Deferral Recommendations for Medications to Prevent, Treat HIV Infection

Today, AABB released Association Bulletin #22-03, which updates recommendations to evaluate donor eligibility and mitigate risks related to the suppression of HIV to undetectable levels in people taking antiviral medications, and the potential impact on donor testing for HIV infection as a result of such medications' suppressive effects, first outlined in Association Bulletin #20-04. 

The new Bulletin describes new information regarding the impact on HIV testing for individuals using long-acting, injectable cabotegravir (Apretude), a highly effective medication approved by the Food and Drug Administration in December 2021 as pre-exposure prophylaxis (PrEP) to prevent HIV infection. Accordingly, AB #22-03 updates recommendations based on published data confirming the medication’s long-acting suppressive effects. These data also support an extended donor deferral period for individuals who have received a cabotegravir injection to address the corresponding potential impact on donor testing for HIV. 

 

It is important to note that this extended deferral period applies to all people who have received a cabotegravir injection, irrespective of their sexual orientation or gender identity, because of the risk for false-negative HIV test results in individuals taking medications for HIV prevention and treatment. This extends to all donors and is not limited to specific subgroups.

The donor eligibility recommendations for all individuals taking oral medications (either as PrEP or post-exposure prophylaxis [PEP] or as antiretroviral therapy [ART] for the treatment of HIV infection), first outlined in AB #20-04, are included in AB #22-03 and remain unchanged. AB #22-03 details the current evidence, and the potential impact of these medications noted in package inserts for both diagnostic and donor screening assays for HIV, presented at AABB’s Aug. 18 Hot Topic Session, Impact of Injectable PrEP on Donor Testing and Screening.

 

AABB intends for the recommendations in this Bulletin to address the eligibility of donors using PrEP, PEP and ART medications until the next version of the Donor History Questionnaire (DHQ), version 3.0, is reviewed and formally recognized by FDA. For this reason, this AB #22-03 provides recommendations that can be used with the current DHQ v2.1 system of documents to address the potential impact of PrEP for a period of months until the version 3.0 DHQ with PrEP, PEP and ART is reviewed and formally accepted by FDA.

 

AABB members may contact AABB Regulatory Affairs with questions.