Context: Oral HIV pre-exposure prophylaxis (PrEP) has been available and fully reimbursed for people at high risk of sexually acquired HIV infection in France since January 2016. Objective.- To evaluate the roll-out of PrEP use in France and its real-life effectiveness. The main results of two previously published studies were presented at the second e-congress of the EPI-PHARE scientific interest group on pharmacoepidemiology and public decision support held in June 2022, and are reported in this article.

Methods: Two studies were carried out using the French National Health Data System (SNDS) covering 99% of the French population. A first study aimed to evaluate the roll-out of PrEP use in France from its implementation until June 2021, globally over the entire study period, including an assessment of the impact of the coronavirus disease 2019 (COVID-19) pandemic that started in February 2020 in France. A second study using a nested case-control design was conducted in a cohort of men at high risk of HIV acquisition included between January 2016 and June 2020 to assess the effectiveness of PrEP in the real world.

Results: As of 30 June 2021, a total of 42 159 people had initiated PrEP in France. Initiations increased steadily until February 2020, then slowed down sharply from the start of the COVID-19 pandemic and resumed from the first half of 2021. PrEP users were overwhelmingly men (98%), with an average age of 36 years, living in a large urban area (74%), and of whom a minority (7%) were socioeconomically disadvantaged. Throughout the study period, the level of PrEP maintenance from one semester to the next was high (80-90%). However, for 20% of PrEP initiators, no prescription renewals were recorded during the first six months, suggesting a substantial proportion of early treatment discontinuation. A minority (21%) of PrEP renewal prescriptions were made by private practitioners. Among 46 706 men at high risk of HIV infection, 256 patients identified with HIV infection were matched with 1213 controls. PrEP was used by 29% of cases and 49% of controls. Overall, PrEP effectiveness reached 60% (95% confidence interval 46% to 71%), and was increased in people with high PrEP use (93% (84% to 97%)), or after excluding periods of treatment discontinuation (86% (79% to 92%)). PrEP effectiveness was significantly reduced in people under 30 years of age (26% (-21% to 54%)) and in socioeconomically disadvantaged people (-64% (-392 to 45)), for whom low PrEP uptake rates or high PrEP discontinuation rates were frequently observed.

Conclusion: PrEP roll-out has been strongly impacted by the COVID-19 pandemic in France. Although it has been substantial among men who have sex with men, additional measures are needed to expand access to PrEP to all other population groups that could benefit from it. Promoting adherence to PrEP (especially among young people and the socioeconomically disadvantaged) will be essential to ensure a higher level of PrEP effectiveness, which has been shown to be lower in real-life settings than in clinical trials.