Using Truvada to prevent HIV transmission reduces the risk of infection. It is not yet authorized in France. The ANSM has accelerated its schedule for examining the case.
Preventing HIV transmission with medication is possible! The antiretroviral Truvada (Gilead) reduces the risk of infection by 86%, according to the results of the French Ipergay trial. But it is not yet authorized for this indication in France. The file has been examined by the National Medicines Safety Agency (ANSM) since October 2013. Contacted by why actor, the Agency acknowledged that these results, presented on February 24 at the BELIEVE (Conference on Retroviruses and Opportunistic Infections), will speed up the schedule.
A “necessary” approach
400 HIV-negative men who have sex with men (MSM) have been taking part in the Ipergay trial since 2012. Conducted in France and Canada, it is testing a new way to prevent HIV transmission: pre-exposure prophylaxis (PrEP) “on demand.” All participants took two tablets before unsafe sex, a third within 24 hours, and a final within 48 hours. Half were taking a placebo, the other half taking Truvada (emtricitabine / tenofovir), which is normally used to treat people with HIV. They also benefited from the usual preventive advice.
“It was necessary to propose new preventive interventions, the objective of which was to strengthen the already existing interventions”, explains Prof. Jean-Michel Molina, coordinator of the Ipergay trial. Indeed, more than 6,000 new infections are declared each year… 43% concern MSM. This solution gives them more flexibility. “The important thing is that the participants have PrEP in hand and decide according to their type of sexual activity, the type of partner. They can choose between condoms, PrEP, both or neither, ”insists Prof. Molina.
Listen to Dr Bruno Spire, president of AIDES: ” The Ipergay trial allowed us to have an absolutely remarkable overall sexual health offer. “
“We accelerated the schedule”
70% of participants in the Ipergay trial did not use a condom during anal penetration. Of the 400 volunteers, only 16 were infected with HIV, the vast majority (14) in the placebo group. The two members of the Truvada group had stopped taking their preventive treatment. These results translate into a relative risk reduction of 86%.
These excellent results should benefit the Truvada file with the ANSM. In October 2013, the AIDES association requested a Temporary Recommendation for Use (RTU). It would make it possible to prescribe dual therapy for prevention to certain populations at risk. But in 12 months, the situation had changed little. The first results gave a boost to the case, according to Dr Caroline Semaille, who participates in the ANSM review committee.
Listen to Dr Caroline Semaille, Director of the Anti-infectious Drugs Directorate: “ It sent a strong signal and we accelerated the schedule. No other European country has done so. It’s clear that the other countries were waiting to see how we were going to position ourselves. “
“It is necessary that the assumption of responsibility be made by the community”
Several details will have to be specified: the target populations of PrEP on demand, the prescription conditions, the doses… but also the possibility of reimbursing the treatment. This last point is major, since the box of 30 tablets costs 400-500 euros. The president of Gilead France, Michel Joly, considers that health insurance coverage is inevitable.
Listen to Michel Joly, President of Gilead France: “ If we want equal access to care, PrEP must be taken over by the community. “
Researchers from the ANRS (National Agency for Research on AIDS and Viral Hepatitis) are counting on a short schedule: “We are on a summer or back-to-school agenda for 2015”, gauges Professor Jean-François Delfraissy, director of ANRS.
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