Background: FDA approved TDF/FTC for PrEP in adults at high risk of sexually-transmitted HIV on July 2012. In 2015, the French Medicine Agency (ANSM) initiated a Temporary Recommendation for Use (RTU) to allow the use of TDF/FTC for PrEP in France in January 2016.
Methods: The RTU is a specific French procedure that secures and regulates an off-label indication of a medicine for unmet medical needs. PrEP RTU protocol allowed TDF/FTC use in adults at high risk of sexual HIV acquisition, using a daily or an on-demand regimen (as prescribed in the ANRS IPERGAY trial). Subject registration is mandatory within the RTU framework. Data are collected by physicians using a dedicated and secured web subject monitoring interface. The RTU protocol provides 3 forms to monitor the use of TDF/FTC for PrEP: initiation form with baseline characteristics, HIV seroconversion form, adverse events and pregnancies form. Data are analyzed and reported to ANSM every 3 months.
Results: From January 2016 to December 2016, 2805 subjects were registered by 199 prescribers in more than 130 clinics in France. Median age was 36 (30-44, IQR), 98.6% were males and 97.4% of them were MSM. The on-demand regimen was prescribed to 59% of subjects. In the 12 months prior to PrEP initiation, 30.6% had ≥ 2 STIs, 10.9% used post-exposure prophylaxis and 19.9% used psychoactive drugs. Four HIV seroconversions occurred for a total follow-up time of 1100 patient-years; rate: 0.36/100 patient-years, CI95% [0.07-7.20]. Two acute HIV seroconversions occurred before inclusion in the RTU with no resistance-associated mutation (RAM). One presented HIV seroconversion at month 1 visit with a 500 cp/ml HIV RNA and a M184I RAM. One presented HIV seroconversion 2 months after PrEP was interrupted by the patient with no RAM detected.
Conclusions: The RTU framework provided the first data in real life setting in France for TDF/FTC for PrEP. All subjects were at high risk of sexual HIV acquisition, most of them were MSM and used an on-demand regimen. Low rate of seroconversion after initiation of TDF/FTC for PrEP was reported underlining the need for close monitoring of these high risk individuals.