REGULATORY UPDATE: AABB Evaluating Deferral Period for New FDA-Approved HIV Prevention Drug

AABB’s Transfusion Transmitted Diseases (TTD) Committee is currently evaluating donor deferral recommendations for individuals using lenacapavir, a long-acting, injectable medication for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

The Food and Drug Administration approved lenacapavir (marketed as Yeztugo by Gilead Sciences) on Wednesday based on data from two phase 3 trials in which more than 99.9% of participants who received lenacapavir remained HIV negative during the study period.

FDA’s approval makes lenacapavir the only PrEP medication in the United States to be administered twice per year. The first FDA-approved injectable PrEP medication, cabotegravir (Apretude, ViiV Healthcare), requires dosing every two months.

AABB will update members with the committee’s recommendation in the coming weeks. Additional information about PrEP and blood donation is available online.