Different guidelines for pre-exposure prophylaxis (PrEP) eligibility estimate HIV risk differently: an incidence study in a cohort of HIV-negative men who have sex with men, Portugal, 2014-2018

Introduction. Guidelines for pre-exposure prophylaxis (PrEP) provide criteria to identify individuals at higher risk of HIV infection. We compared the ability to predict HIV seroconversion of four guidelines: the World Health Organization (WHO), the United States Public Health Service and Centers for Disease Control and Prevention (US CDC), the European AIDS Clinical Society (EACS) and the Portuguese National Health Service (PNHS). Aim. We aimed to measure the association between guideline-specific eligibility and HIV seroconversion. Methods. We studied 1,254 participants from the Lisbon Cohort of men who have sex with men with at least two evaluations between March 2014 and March 2018, corresponding to 1,724.54 person-years (PY) of follow-up. We calculated incidence rates (IR) according to each guideline eligibility definition and incident rate ratios (IRR) to test the association between eligibility at baseline and HIV seroconversion. Results. We found 28 incident cases (IR: 1.62/100 PY; 95% confidence interval (CI) 1.12–2.35). Guidelines’ sensitivity varied from 60.7% (EACS) to 85.7% (PNHS) and specificity varied from 31.8% (US CDC) to 51.5% (EACS). IR was highest among those defined as eligible by the PNHS guideline (2.46/100 PY; IRR = 4.61; 95% CI: 1.60–13.27) and lowest for the WHO guideline (1.89/100 PY; IRR = 1.52; 95% CI: 0.69–3.35). Conclusions. Being identified as eligible for PrEP was associated with a higher risk of infection. The magnitude of risk varied according to the guideline used. However, the number of HIV infections identified among ineligible participants highlights the potential for missing people who need PrEP.This study was partially funded by FEDER funds through the Operational Programme for Competitiveness and Internationalisation and by national funds of Fundação para a Ciência e Tecnologia (FCT), under the scope of the Research Unit of Epidemiology–Institute of Public Health of the University of Porto (EPIUnit) (POCI-01-0145-FEDER-006862;); Paula Meireles was the recipient of PhD grant SFRH/BD/112867/2015 co-funded by the FCT and the Programa Operacional Capital Humano/Fundo Social Europeu (POCH/FSE) Program