How do PrEP/PEP medications affect donor testing for HIV? PrEP and PEP make it difficult for HIV to multiply after the person is exposed - this is called viral suppression. You may have heard the public health message “ Undetectable=Untransmittable ,” also called U=U for sexual contact. When a viral load is “undetectable,” it means the level of virus is so low that it cannot be detected by an HIV test. In the case of blood donation, it means that a donor test for HIV may not detect the virus at these low levels, but HIV could still be transmitted  through a blood transfusion.

If you must be HIV negative to use PrEP/PEP for HIV prevention, why is a medication deferral necessary? PrEP/PEP medications are highly effective at preventing HIV transmission when used as prescribed. However, the medications are not 100% effective, and it is possible to become infected with HIV while taking them. If PrEP/PEP is not used as prescribed, there is a greater chance for becoming infected with HIV. This is called a “breakthrough” HIV infection. There is another important point to understand: In a donor with a breakthrough infection, PrEP/PEP medications may cause the level of HIV in the blood to drop to a level that cannot be detected when a donor is tested for HIV. That means an infected person taking PrEP/PEP medications could unknowingly transmit HIV to a patient who receives the blood transfusion.

Why are people using injectable PrEP deferred for longer than those taking oral PrEP/PEP medications? Injectable PrEP can suppress the virus to undetectable levels for a much longer period of time than oral PrEP/PEP medications.

Does this medication deferral only apply to men who have sex with men? No, the deferral applies to everyone.

• The medication deferral is not related to a donor’s gender or sexual identity.
• The medication deferral is not related to risk associated with sexual activity.
• PrEP/PEP medications can be used by anyone for the prevention of HIV infection.
• The medication deferral applies to ALL people who have taken PrEP/PEP to reduce their risk of HIV.
• The only reason for the medication deferral is the medication’s ability to decrease the level of HIV to the point that is cannot be detected when a donor is tested for HIV

Exposure of transfusion recipients to blood from asymptomatic CJD donors has been demonstrated; however, no transfusion-transmitted cases of CJD have been reported, and the risk of such transmission remains theoretical. Standard procedures are in place to assure that donors are healthy at the time of donation and serve as an effective safeguard against collecting blood or blood components from a donor after the onset of clinical symptoms of CJD.

Why is the criteria being changed?

To simplify the donor screening process and increase the number of eligible donors while maintaining the safety of blood and blood components. Donors previously deferred for these reasons are eligible for reassessment and re-entry as a blood donor.

UK travel

Risk assessment models, which FDA has independently evaluated, demonstrate that, in the UK, the current risk of vCJD transmission by blood and blood components would expose transfusion recipients to no or minimal additional risk of vCJD in the future, and, for blood components that are leukocyte reduced, the possible risk is even further reduced.

France/Ireland travel

Additionally, based on the smaller number of vCJD cases in France and Ireland, FDA expects the risk of vCJD transmission by blood and blood components in France and Ireland would be even lower than what was modeled in the risk assessments for the U.K

France/Ireland blood transfusion

Risk assessment of transfusion-transmitted vCJD in the U.K. predicted a very small number of cases might be associated with plasma or platelet transfusion and we (FDA) believe there would be an even lower risk of transfusion-transmitted vCJD in France and Ireland.

AABB has reviewed changes for the Donor History Questionnaire (DHQ) and submitted a new version to the FDA for review. The three questions remain on the questionnaire for the time being, but donors will no longer be deferred.