This is an important step in the fight against infection with the AIDS virus.
On July 25, the European Medicines Agency (EMA) gave its agreement to the European Commission for “a marketing authorization for Truvada (emtricitabine/tenofovir disoproxil) within the EU”. This drug, produced by the American laboratory Gilead, considerably reduces the risk of HIV infection in adults at high risk.
Truvada was initially authorized in 2005 in the EU, “in combination with another antiviral”, to treat adults with HIV infection.
The EMA relied on 2 large studies carried out on patients which showed its effectiveness in preventive use. The agency indicates that it observes a “consequent reduction in the risk of infection when Truvada was used in PrEP treatment (for pre-exposure prophylaxis)”.
The authorization of Truvada is now subject to the decision of the European Commission. It will then be up to each member country to set the price and the conditions for reimbursement of the drug to start marketing it.
France had already authorized the use of Truvada
At the end of 2015, France had authorized the prescription of Truvada “in a supervised manner” in hospitals as well as its “100%” coverage, thus becoming the first European country, and the second in the world after the United States, to give the green light to the preventive use of the famous drug.
At the beginning of June, the Ministry of Health also gave its authorization for its prescription in free AIDS information and screening centres.
The two major studies (Proud and Ipergay) carried out since 2010 on the effectiveness of Truvada as a preventive treatment already showed very encouraging results. Thus, an 86% reduction in the risk of infection was observed in a group of participants. The iPrEx study, relayed in the EMA press release, was carried out on a much larger number and brings equally satisfactory results.
The EMA recalls that Truvada “must be an integral part of an overall prevention strategy” and “cannot replace the use of a condom” which remains the only means of protecting oneself “not only against the AIDS but also other sexually transmitted diseases”.
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