Use of DNA profiling to resolve HIV status in a person using injectable cabotegravir for HIV pre-exposure prophylaxis

HIV diagnosis can be especially challenging in persons using long-acting cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) due to long-acting early viral inhibition, “LEVI”. 1 New infections are usually clinically silent in this setting and are often missed using routine screening assays due to prolonged viral suppression and delayed/diminished antibody (Ab) production. Tests for HIV antigen (Ag), Ab, RNA and DNA may also revert from reactive/positive to non-reactive/negative.1–3 We evaluated a case where unexpected HIV laboratory results complicated the clinical management of a participant in the HIV Prevention Trials Network (HPTN) 083 trial.4 The results also complicated assessment of the primary study endpoint (incident HIV infection). Laboratory testing was performed in real time at the study site and retrospectively at the HPTN Laboratory Center (LC) and other reference laboratories (online supplemental file 1).