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.