n.
The U.S. FDA recently issued draft guidance to reduce the risk of HIV transfusion-transmission using individual risk-based questions instead of deferring men who have sex with men (MSM) and women who have sex with MSM. Beginning in 1985, the FDA recommended indefinite deferral for MSM to donate blood. Guidance was updated in 2015 to recommend a 12-month deferral for sexually active MSM and reduced it to a 3-month deferral during the COVID-19 pandemic. Based on surveillance data, new testing platforms, experience in other countries, and new drugs to prevent and treat HIV [pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)], the revised FDA draft guidance recommends the following:
- 3-month deferral for any potential donor who has had one or more new sexual partners and anal sex within the past three months
- 3-month deferral for anyone with more than one sexual partner and has had anal sex within the past three months
- 3-month deferral for anyone taking oral, short-acting medicine to prevent HIV (i.e., short-acting PrEP or PEP)
- 2-year deferral for anyone who has received an injection of long-acting antiviral to prevent HIV (i.e., long-acting PrEP)
- Permanent deferral for anyone with confirmed HIV or has taken antiretroviral therapy (ART) to treat HIV
The Association for the Advancement of Blood and Biotherapies (AABB) supports this new draft guidance and encourages the FDA to finalize it after the public comment period.
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