New Injectable PrEP Medication Added to the AABB Medication Deferral List, With Toolkit to Support Implementation

AABB has updated the AABB Medication Deferral List (MDL), version 4.0, to include lenacapavir (Yeztugo, Gilead), a recently FDA-approved, long-acting injectable pre-exposure prophylaxis (PrEP) medication. Lenacapavir is the first and only PrEP option available in the United States that requires administration just twice a year. AABB also released a new toolkit to support implementation.

Prior to FDA’s approval, the AABB Transfusion Transmitted Diseases (TTD) Committee formed a working group to evaluate the available pharmacokinetic data and to consider a donor deferral period. Following careful review, the TTD Committee recommended maintaining the current Donor History Questionnaire (DHQ) v4.0 and the associated deferrals, and adding lenacapavir to the MDL v4.0 with a two-year deferral period. The committee sent the recommendation to the AABB Donor History Task Force (DHTF), which approved the addition and updated the MDL v4.0 accordingly. 

This minor addition to the MDL v4.0 does not require a version update. As described in the DHQ v4.0 User Brochure, the update to the MDL should be implemented as defined in the blood collection establishment standard operating procedures and as soon as reasonably possible. Under 21 CFR 601.12(d), licensed blood establishments are required to report this minor change and its implementation date in their next annual report.

AABB would like to sincerely thank the TTD Committee and the DHTF for their work, dedication and continued efforts to ensure that blood remains safe and available for the patients we serve.