At the end of July, the European Medicines Agency (EMA) considered the clinical trials of Truvada conclusive and gave its agreement to an extension of the authorization to market the drug. All that was needed was the approval of the European Commission (EC) to make a final decision.
This is now done since the use of Truvada has been validated by the EC, in the context of use in pre-exposure prophylaxis (PrEP), associated with safer sex practices. All the countries of the European Union will therefore soon be able to benefit from the drug as a preventive treatment.
Initially authorized by the EMA in 2005, in combination with other antiretrovirals, Truvada, a product of the American laboratory Gilead, is today the antiretroviral treatment most prescribed in Europe to treat adults infected with HIV. With this MA authorization, it can also be used to prevent the risk of HIV infection in adults at high risk of infection.
A new HIV prevention tool
Indeed, the marketing authorization for Truvada as PrEP is based on the results of two large controlled trials of the drug, the iPrEX trial and the Partners PrEP trial. In all studies, the nature and incidence of the side effects (headache, stomach ache, and weight loss) were consistent with the safety and tolerability profile of the medicine when used as part of a treatment. HIV treatment.
“For thirty years, anti-HIV treatments have progressed enormously, however the rates of contamination continue to increase. The number of diagnosed infections has also reached a record level in 2014 within the European Union; 94 % of infections for which the cause is known are sexual, “declares Prof. Jean-Michel Molina, head of the infectious and tropical diseases department at Saint-Louis Hospital (AP-HP). This authorization provides a new HIV prevention tool that “will allow HIV-negative people at high risk of HIV-1 contamination to protect themselves against the virus”.
Truvada has already been authorized for use in PrEP in several countries: the United States, Australia, Canada, Kenya, Peru and South Africa.
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 be given. its green light for the preventive use of the famous drug.
However, recommendations are necessary
“Truvada should not be used as PrEP in individuals with unknown or positive HIV-1 status, as the drug taken alone is not a complete treatment for HIV-1, and HIV-1 resistance mutations have developed. in people with an undetected HIV-1 infection, and only treated with Truvada “reports the Gilead laboratory press release.
This is in addition to the recommendations issued by the EMA on the Truvada last July. The agency recalled that the use of the drug in preventive treatment “must be an integral part of an overall prevention strategy” and “cannot replace the use of a condom” which remains the only means of protection ” not only against the AIDS virus but also against other sexually transmitted diseases “.
Source: Gilead laboratory press release
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