Under current federal rules, men cannot donate blood if they have had sex with another man in the last three months.
tested out relying on questionnaires to screen donors, instead of broad "time-based deferrals."
"Although we do not have a specific timeline for when our analysis will be complete, the agency believes the initial data from the study, taken in the context of other data available from blood surveillance in the U.S. and in other countries, will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission," the FDA's Carly Kempler said in a statement.
Kempler said the FDA had not yet determined when and how the study's results would be published. The agency is working on draft guidance to be released "in the coming months" that would incorporate results from the study and other "international developments in donor deferral policies." Several countries have already shifted away from broad waiting periods for gay men to narrower screening approaches, including Canada"We have highly relevant information to envision what an individual risk-based approach would look like," Vitalant Research's Brian Custer, the study's principal investigator,While donated blood can be tested for HIV, it can be difficult for most blood banks to detect the virus during the early "window period" after infection.
"The ADVANCE Study is examining if different questions could be added to the donor history questionnaire that are based on individual risk of HIV infection, and if these questions would be as effective as a time-based deferral," Gehrig said.A ban on blood donations from men who have sex with men was first imposed in the 1980s, in the early days of the HIV/AIDS epidemic, when much less was known about the virus and treatment options did not yet exist.
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