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Truvada, a preventive anti-HIV drug manufactured by the American Gilead, has been delayed by nearly 20 months in its investigation, according to a report of the General Inspectorate of Social Affairs (Igas) made public Monday July 9, 2018. Treatment is also insufficiently used in France by homobaduals and people born in countries of sub-Saharan Africa, which constitute the majority of people infected each year in France, This means of prevention called pre-exposure prophylaxis ( PrEP) is the subject of a poster campaign by the badociation Aides
CONTEXT . Truvada is a treatment against AIDS authorized in France and Europe since 2005. Its use in preventive (PrEP) was validated by the United States in 2012. In France, it is the badociation AIDES which had to seize in 2013 the Agence du Médicament (ANSM) to try to achieve the same result. The procedure chosen is that of the temporary recommendation for use (RTU), which allows the drug to be made available more quickly within the time allowed for marketing authorization (MA). It is only in January 2016 that the Truvada gets this RTU. The principle of PrEP is to stop the virus by taking Truvada tablets continuously every day or on an ad hoc basis the day before and the days following intercourse.
" 20 months late "in the instruction of the Agency of Medicines, denounces the Igas
This mission report inspectors Gilles Duhamel and Aquilino Morelle of the General Inspectorate of Social Affairs (Igas) points a length of instruction of the recommendation Temporary Use (RTU) of Truvada " unusually long ". It lasted 35 months, instead of an estimated period " normal " of 15 months. A duration that corresponds to those of other agencies in the world, which took between 7 months in the United States and 14 months in Scotland. The implementation of this preventive measure, PrEP, took place three years after the Aides badociation applied to the French Medicines Agency (ANSM), and 3.5 years after the authorization of this preventive treatment. United States, intervened on July 16, 2012.
The experts estimate the number of contaminations that could have been avoided without this delay between a few hundred and several thousand people according to the scenarios. They thus advance the figure of " 1.666 to 4.000 " preventable contaminations on a hypothesis – of which they did " not have the possibility to verify the foundations ", they specify – of the General Directorate of Health who estimated that " the number of contaminations avoided (thanks to PrEP ) would potentially be 1,000 to 2,400 per year ". This number falls to 350 preventable contaminations " taking into account a progressive scaling up of the device " which according to the studies protects 6% of concerned, emphasizes the Igas.
" A much of the accumulated delay in education results from a form of medical and administrative wait-and-see "
" One can only legitimately wonder about what would have happened and, to be precise , on the additional delay which would have resulted ", if the badociation AIDES" had not taken the initiative to seize the ANSM to ask him the commitment of this RTU ", argues Igas. It was " yet the mission " of " one of the authorities responsible for public health " such as " the Minister of Health and Social Security ( DGS, cabinet), the ANSM, or the HAS ", point the experts.
" A large part of the delay accumulated in the instruction results from a form of medical and administrative wait-and-see ", point the experts, but also of a" overestimation of the risks "related to the introduction of PrEP. Among these risks, " even more relaxed behaviors vis-à-vis the condom ", the " occurrence of resistance to the drug ". Condom misuse would result in efficiency of only 80% for heterobaduals and 70% for men who have bad with men. However, for Igas, PrEP is the consequence of the relaxation of condom use and not its cause. As for resistance, the experts consider that it is in any case a risk " inevitable ".
Even late, France is the first country in Europe to have authorized the PrEP by Truvada
Even though the instruction was very slow, the RTU device still " allowed France to earn 7.5 months compared to the authorization European Marketing Authorization (AMM) and avoid between 600 and 1,500 HIV infections "adds Igas. The European Agency has indeed made its decision in August 2016 (against January 2016 for France), that is to say 6.5 months after the laboratory Gilead has made the request. " France was the first country in Europe to effectively allow, from January 2016, the use of Truvada as a preventive measure ", says indeed to AFP Dr. Dominique Martin , Director General of the Agence du médicament. " This (last) evaluation of the Igas is an absurd paradox compared to the reality, since one intervened before the other European countries ", he is indignant. In fact, " PrEP is still little used – by only 6% of the people concerned, according to the data we have " he says, noting that the 2015 DGS estimates ( "the number of contaminations avoided – thanks to PrEP – would potentially be 1,000 to 2,400 per year" ) " higher than today ". [19659002] INEQUALITY OF ACCESS . The RTU ended on 1 March 2017, with the extension of the marketing authorization of this product for prevention. However, the inspectors emphasize " a double inequality in access to treatment: territorial inequality (for the benefit of metropolitan urban areas) and insufficient recourse among men who have bad with men (MSM) and those born in heavily affected countries, mainly from sub-Saharan Africa, which constitute the vast majority of some 6,000 new infections each year "
HOW TO ACCESS THE PREP? " Only a doctor experienced in the management of HIV infection, practicing in the hospital or in a free information, screening and diagnostic center (CeGIDD) may make the first prescription of the PrEP ", explains the High Authority of Health (HAS). " The renewal of the prescription can be carried out by any doctor, in town or at the hospital ", but " the prescription must be repeated each year in the hospital or in CeGIDD "
With AFP
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