FDA Issues Draft Guidance for Individual Risk Assessment of HIV Transmission
On January 27, 2023, the Food and Drug Administration (FDA) released a draft guidance proposing changes to the blood donor eligibility screening questionnaire. The proposed changes would focus on questions based on each donor’s individual risk factors for HIV, instead of assessing donor eligibility with broad, gender-based questions. Once the guidance receives final approval it will bring the United States in alignment with other countries like Australia, Canada, and the United Kingdom, who already have implemented an individual risk policy for blood donation assessments.
When the AIDS epidemic began in the early 1980s it was soon realized that AIDS was infecting men who have sex with men (MSM) at a higher rate than other groups. AIDS was later identified as a bloodborne disease that could be contracted by receiving a blood transfusion. A few years later, the virus that causes AIDS, Human Immunodeficiency Virus, was discovered. In 1985, testing for HIV was required for every blood donation. With this knowledge, the FDA implemented an indefinite deferral for MSM from donating blood.
Over the decades, improvement in sensitivity of blood donation screening tests decreased the rate of transfusion-transmitted HIV infection from 1 in 2500 units in the 1980s to an estimated 1 in 47 million units in 2022. In addition, data from research studies in disease transmission from blood transfusion has allowed the FDA to progressively relax the time-based deferral period for blood donation for MSM from an indefinite deferral in 1985 to a three-month deferral in 2020. Likewise, the deferral period for other blood-related risks-- such as individuals who exchange sex for money or drugs, inject non-prescription drugs, received a recent tattoo at an unregulated facility, received a blood transfusion or were exposed to blood-- was also shortened to three months.
The FDA reviewed transfusion-transmitted infection data after decreasing the deferral period for MSM, funded a study to evaluate individual risk strategies, and noted other countries with similar HIV epidemiology who have adopted an individual risk-based approach have not reported safety concerns post implementation. After considering these factors, the FDA concluded a gender-inclusive, individual risk-based screening of blood donors will not increase the risk of transmitting HIV by blood transfusion.
The new proposed individual risk method of screening will ask all donors if they have had a new sex partner in the last three months, the number of sex partners in the last three months, and if they have had anal sex in the last three months. Questions related to taking medication to treat or prevent HIV, exchanging sex for money, injecting non-prescription drugs, recent tattoos and piercings, and exposure to blood will continue to be asked of all donors. Based on how a donor answers questions to assess HIV risk, they may be deferred three months, two years, or permanently, but the deferral will no longer depend on their gender, but on their individual risk.