ANRS SimpPrEP study

The project

What is HIV pre-exposure prophylaxis?

Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy based on the use of antiretroviral drugs in people who do not have HIV. It is taken before exposure to the virus and continues after potential exposures in order to prevent acquisition of the virus. Various studies have demonstrated its effectiveness in men who have sex with men (MSM).

What is the aim of the SimpPrEP study?

The ANRS 0029s SimpPrEP study is a phase III, open-label, parallel-group, randomised controlled trial in MSM in Thailand and France.

The aim of the study is to evaluate the efficacy, acceptability and safety of simplified pre-exposure prophylaxis based on the combination of 2 treatments, tenofovir alafenamide and emtricitabine (TAF/FTC), in HIV-uninfected cisgender men who have sex with men (MSM). The treatment is administered orally with a simplified dosing schedule, i.e. one dose taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first dose. The primary objective of the study is to determine the efficacy of FTC/TAF PrEP in reducing the risk of contracting HIV in MSM compared with the background HIV incidence rate. Among the secondary objectives, the efficacy of FTC/TAF was compared with that of on-demand prophylaxis with emcitrabine/tenofovir disoproxil fumarate (FTC/TDF).

Which patients can take part?

The patients must be men aged ≥ 18 years who report having had sex with men. 4th generation HIV-1 and HIV-2 tests must be negative. Assessment of the risk of contracting HIV is based on self-report of at least one sexual behaviour exposing the patient to the risk of HIV in the 6 months prior to inclusion in the study.

What are the expected results?

The study will assess the number of test-confirmed HIV infections that occur during follow-up, patient acceptance of the treatment, and tolerance by monitoring the occurrence of side-effects.

What is the planning?

Inclusion began on 05 June 2024 in Thailand; the study has not yet begun in France. 524 participants are expected to be recruited. The total duration of inclusion is 4 years.