Hemophilia Group Endorses FDA’s New Plasma Donor Guidelines

Decades after blood products contaminated with the HIV virus infected thousands of people with hemophilia, this population remains nervous about changes in blood donor screening requirements.

However, the National Hemophilia Foundation is standing behind what the FDA says are evidence-based changes that will not increase the risk of infection from HIV but will allow more individuals to donate blood.

“I can say with confidence that the way the FDA went about considering alternative screening was scientific, it was objective, although it took longer than many would have preferred,” said Nathan Schaefer, MSW, vice president of public policy for the National Hemophilia Foundation.

In changing the screening protocol that will be adopted by blood donation centers across the United States, the FDA relied heavily on just-released results of the ADVANCE study.

The ADVANCE study demonstrated that it is possible to identify a sub-population of men who have sex with men (MSM) whose risk of donating plasma infected with HIV is lower. This subpopulation is identified as individuals who self-report no new sexual partners and just one sexual partner within the past three months, prior to attempted blood donation.

In formulating its new guidelines, the FDA decided to allow this subgroup to donate blood without having to wait. Previously, MSM and women who have sex with MSM were subject to a 12-month automatic deferral on donation.

Individuals who report new sexual partners or multiple partners within the past three months will then be asked if they have also had anal sex in the previous three months. Those who respond positively to this question will be deferred from donating for three months.

One key difference in the new guidelines is that they allow for more rigorous screening of heterosexual populations. Women who have had a new sexual partner or multiple partners within the previous three months and who have had anal sex in that period also would be deferred from donating for three months. (See page 8.)

“Before this policy, heterosexual people could have had unprotected sex with many partners and not only would they be eligible to donate, but they wouldn't have been asked about their behavior at all,” Schaefer said. “So, the new policy actually excludes some high-risk people who were formally eligible to donate.”

The guidelines continue to recommend deferrals for individuals who have ever tested positive for HIV and those who are taking medications to prevent HIV, such as pre- and post-exposure prophylaxis.

Such antivirals can protect against HIV transmission during sexual intercourse, but “do not fully eliminate the HIV virus from the body, and donated blood from individuals infected with HIV taking [antiretroviral therapy] can potentially still transmit HIV to a transfusion recipient,” the FDA wrote.

Recombinant coagulation factor products have made the hemophilia population far less reliant on donated plasma supplies, and much safer, although this is not necessarily the case in less-advanced countries.

Extremely sensitive tests for evaluating donated blood, along with donor screening, have reduced the risks of HIV transmission from donated blood to less than one in 1 million transfusions, and decades have passed without a recorded HIV infection this way, the FDA said.