HIV incidence in US first-time blood donors during 12 and 3 month deferral policy periods between 2015 and 2023 before implementation of individual donor assessment.

Background: Following FDA guidance, US blood collectors changed donor deferral for men who have sex with men (MSM) from indefinite to a 12 month deferral in 2016 (12 m), and for MSM and several other exposure risks to 3 month deferrals in 2020 (3 m). We evaluated first-time donor (FTD) HIV incidence and demographics during these periods.

Study design and methods: We estimated cross-sectional HIV incidence and incidence rate differences in FTD based on routine donation nucleic acid testing (NAT) and serology with additional limiting antigen (LAg)-Avidity immunoassay and viral load testing. We estimated incidence in the two policy periods (12 and 3 m), incidence trends in two-year intervals between 2015 and 2023, and used multivariable Poisson regression to assess demographic correlates of incident infection.

Results: HIV incidence in FTD during the 12 m deferral period was 2.82 infections/10⁵ person-years (PY) [95% CI: 2.12, 3.67] and during the 3 m deferral period, it was 1.88/10⁵ PY (95% CI: 1.18, 2.67), a statistically significant decline (p < .05). Over the period 2015-2023, incidence was stable. Male sex, younger age, Black or African American race, Hispanic ethnicity, and residence in the South were associated with incident infection in regression analysis, but the time-based deferral policy periods were not.

Discussion: HIV incidence in FTD did not increase between 2015 and 2023. An overall decline in HIV incidence in the 3 m deferral period compared with the 12 m deferral period was evident. These results provide no indication of an increased residual risk of transfusion-transmitted HIV from FTD in the United States with the reduced deferral periods.