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Important Information for Potential Donors of Blood and Blood Products

Individuals who have ever tested positive for HIV should not donate blood

Date:  December 20, 2019

The Food and Drug Administration (FDA) would like to remind the public that individuals who have ever tested positive for HIV (the virus that causes AIDS) should not donate blood, because of the potential risk of transmitting HIV to others. This is consistent with FDA’s current policy on blood donation.

A recent study of the blood supply in the United States identified some HIV-positive blood donations from individuals who were taking antiretroviral drugs.1 To date, there have been no reported cases of HIV transmission to transfusion recipients by blood donated by such individuals. However, FDA is concerned about the risk that such donations pose to the overall safety of the blood supply.

FDA-approved antiretroviral drugs are safe and effective and can reduce the HIV viral load of individuals to undetectable levels as determined by conventional testing. However, these antiretroviral drugs do not fully eliminate the virus from the body, and donated blood can potentially still transmit HIV infection to a transfusion recipient. Although undetectable still equals untransmissible for sexual transmission (U = Usex), this does not apply to transfusion transmission.

FDA’s aim in providing this important advice is to ensure the continued high-level safety of the U.S. blood supply for everyone.

 

1 Custer et al. Detection of antiretroviral therapy use in US blood donors. Transfusion 2019;59 Suppl S3, 9A.

 

 

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