between 1600 and 4000 contaminations due to the late introduction of Truvada

Has the National Agency for the Safety of Medicinal Products (ANSM) waited too long before granting Truvada anti-HIV prophylaxis for pre-exposure prophylaxis (PrEP) before premature badual intercourse, its marketing authorization?

This is what a report from the General Inspectorate of Social Affairs (IGAS) procured Le Monde put forward. According to the administrative service, the ANSM's "abnormally long" investigation of the case was not inconsequential since during the 35 months of the process, between 1,666 and 4,000 people were infected with HIV.

Accumulation of delays

Truvada's long history of placing on the market started in January 2013, when AIDES applied to ANSM to request that Truvada be made available on the market. At this time, the drug still raises serious concerns from some anti-HIV badociations, who fear that the drug PrEP will undermine their campaign of prevention focused on the use of condoms.

From the first months, the delays have accumulated: Le Monde explains that the Gilead laboratory, which manufactures Truvada, took four months to provide ANSM with the necessary documents to examine the file. Between October 2013 and July 2014 – or 9 months – "no discernible procedure has occurred" to the ANSM, says the report. AIDES finally restarted the ANSM in May 2014 and received a response from the Minister of Health Marisol Touraine July 7.

Is then appointed two weeks later by the Agency of Medicines a scientific committee to prepare the "Temporary recommendation of use" (RTU) by which the ANSM can frame prescriptions not in conformity with the authorization of placing on the market (AMM), specifies the daily.

In January 2015, nearly two years after the referral of the ANSM by AIDES, the scientific committee finally begins its work, which it renders at the end of the year. The Truvada finally receives its temporary recommendation for use, which does not take effect until January 2016. That is 35 months after the start of the training.

"The delay accumulated in Truvada RTU training was most of the important players at the time: partners of the public health administration in the first place – community leaders in particular – but also stakeholders, collaborators and even leaders of this administration, stresses the report which continues: several of them reported that the RTU dossier, which was important in terms of public health, had seemed to them to be 'bogged down' or 'buried' for too long a month, "writes IGAS in its report.

Between 1,600 and 4,000 infections that could have been avoided

This expectation was not without consequence. According to the IGAS, which is based on data from the Directorate-General for Health, an earlier placing on the Truvada market could potentially have avoided 1,666 to 4,000 HIV infections.

Interviewed Monday 9 July France Inter, former president of the badociation AIDES Bruno Spire, believes that "the administration, and many members of the medical corps, have a responsibility in the fact that people were contaminated during this period while they could have benefited from early access. "

At present, about 7,000 people in France use Truvada as a preventative treatment for HIV. His clinical trial reports a reduced risk of contamination of 86%. France is the first country to have authorized its placing on the market.