Updated Donor Eligibility FAQ

A “new sexual partner” includes the following examples:

• Having sex with someone for the first time

OR

• Having had sex with someone in a relationship that ended in the past and having sex again with that person in the last three months.

According to the FDA, anal sex has a statistically significant increase in HIV transmission per occurrence compared to vaginal or oral sex. This does not account for individuals’ safe sex practices but is based on an evidence-based approach to overall transmission rates.

FDA data shows that multiple sexual partners can increase the chance of HIV transmission. Further, the possibility of a new/recent infection of HIV that cannot be detected by current testing methods (particularly “window period” infections) increases with new sexual partners and multiple sexual partners. The FDA has determined, statistically, anal sex has a significantly higher possibility of HIV transmission per sex act compared with vaginal or oral sex.

Pre-exposure prophylaxis (PrEP) is a highly effective medication regimen used for HIV prevention.

However, in people taking PrEP or post-exposure prophylaxis (PEP), the low levels of HIV may be missed by current testing methods. The blood community relies on accurate HIV testing as part of its multilayered approach to safety. There needs to be more research on how PrEP and PEP affect HIV testing. Currently, the FDA recommends that individuals who take oral PrEP or PEP be deferred from donation for three months from their most recent dose. For individuals who have received PrEP by injection, the FDA recommends deferral from blood donation for two years from their most recent injection. This is an issue impacting blood operators worldwide. Tests used to detect HIV and other viruses are manufactured by independent companies, not blood collectors or regulatory bodies. Work to understand the true impact of PrEP and PEP medication regimens on HIV tests can only be completed in collaboration with or directly by the manufacturers of the test, who hold the licensing for these products.

DO NOT STOP TAKING ANY PRESCRIBED MEDICATIONS IN ORDER TO DONATE BLOOD, INCLUDING PrEP and PEP MEDICATIONS.

It’s incredible that HIV care has reached a point where people’s viral loads can be “undetectable.” However, “Undetectable = Untransmittable” does not apply to blood donors and the potential infection to transfusion patients. Even blood donated by those who have an undetectable viral load could potentially put a patient in jeopardy of HIV infection following a blood transfusion. The FDA-approved antiretroviral drugs are safe and effective in preventing sexual transmission of HIV. However, these antiretroviral drugs do not entirely eliminate the virus from the body, and donated blood can potentially still transmit HIV infection to a transfusion recipient. The possibility of transmission is much higher with a unit of blood due to the large volume of blood in a transfusion and the much higher total amount of virus present.

DO NOT STOP TAKING ANY PRESCRIBED MEDICATIONS IN ORDER TO DONATE BLOOD, INCLUDING PrEP and PEP MEDICATIONS.

Based on its review of currently available scientific data, our FDA determined that this change will not compromise the safety or adequacy of the United States blood supply and that the updated donor screening process will continue to defer those with a higher chance of acquiring a new HIV infection. Other criteria already in place identify additional factors for contracting HIV, and these will continue to be applied. Evidence from the ADVANCE Study, the TTIMS monitoring system, and other data assessed by the FDA support making this change.

Currently, the possibility of HIV being introduced to the blood system is extremely low. All available evidence confirms that an individual donor assessment approach to screening will continue to ensure the highest safety and quality for the blood supply.

MEDIC tests every donation for many different infections that could potentially be transmitted by blood transfusion. However, no test is perfect, and there are some infections for which there is no reliable test available. One reason we have such a safe blood supply is the layering of a donor screening questionnaire with donation testing. Tests used to test every blood donation have a limitation called the “window period.” The window period is the time between when a donor has acquired a new infection and can transmit it to the time a lab test can reliably detect the infection. If a donor has recently acquired an HIV or hepatitis infection, current testing methods may not pick it up. The Donor History Questionnaire is critical in helping identify recent exposure to an infection.

The FDA recommends individual donor assessment screening criteria that focus on anal sex in the context of new or multiple partners rather than vaginal or oral sex. This is because, statistically, anal sex has a significantly higher chance of HIV transmission per sex act than vaginal or oral sex. Multiple sexual partners can increase the chance of HIV transmission. This does not account for individuals’ safe sex practices but is based on an evidence-based approach to overall transmission.

Yes. If you are having anal sex with one person you’ve been with for at least three months, you will be able to donate as long as you meet all other eligibility criteria. All donors are asked if they’ve had a new partner in the past three months or multiple partners in the past three months. Donors who have only one sexual partner that they’ve been with for three months or longer won’t be asked about anal sex.