Impact of Early Antiretroviral Treatment Initiation on Performance of Cross-Sectional Incidence Assays

Antiretroviral therapy (ART) can impact assays used for cross-sectional HIV incidence testing, causing inaccurate HIV incidence estimates. We evaluated the relationship between the timing of ART initiation and the performance of two serologic HIV incidence assays. We analyzed 302 samples from 55 individuals from the RV217 cohort (Early Capture HIV Cohort Study). Participants were grouped by ART start time: ART started <1 year after infection (N = 9); ART started 1-3 years after infection (N = 12); and never received ART (N = 34). Samples were tested using the Sedia LAg-Avidity and Johns Hopkins modified Bio-Rad-Avidity assays. Results were compared with those from the Johns Hopkins HIV Cohort in which participants initiated ART an average of 10 years after infection (N = 17). Participants on ART were virally suppressed at the time of sample collection. The increase in normalized optical density (ODn) values was an average of 2.15 U/year lower in participants who started ART <1 year after infection than in those who did not start ART. Participants who started ART 1-3 years after infection had a decline in ODn values 0.90 U/year faster compared with those who started ART an average of 10 years after infection. Timing of ART initiation did not significantly impact results obtained with the Bio-Rad-Avidity assay. ART initiation <1 year after HIV infection was associated with persistently low limiting antigen (Lag)-Avidity values; this could lead to overestimation of HIV incidence. LAg-Avidity values declined more rapidly the earlier ART was initiated. Bio-Rad-Avidity values were not impacted by the timing of ART initiation.