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France Approves Truvada for HIV Pre-exposure Prophylaxis

In a historic move, France has become the first country outside the U.S., and the first country with a centrally organized, reimbursable health system, to approve no-expense pre-exposure prophylaxis (PrEP) for people who need it. The French Minister of Health, Marisol Touraine, announced on November 24 today that PrEP would be available starting in mid-December, and reimbursable through the French health system from the beginning of January.

[Produced in collaboration with Aidsmap.com]

The positive recommendation for Truvada (tenofovir/emtricitabine) PrEP comes via a uniquely French health measure called a Recommendation of Temporary Use (Recommandation Temporaire d'Utilisation -- RTU). This provides for drugs to be made available to people in urgent need on an "off-label" basis, i.e., without a full Marketing Authorization. RTUs are used for drugs that already have Marketing Authorization for other uses -- in this case, for HIV treatment.

Mme. Touraine said: "I am in favor of the RTU, which should take effect in the first two weeks of December. Given the level of efficacy of this approach, which has been recognized by all national and international scientific experts in the battle against HIV/AIDS, I take the financial responsibility for this treatment, which can contribute to complete our global strategy against HIV and AIDS, so it can be available without financial restriction."

She added, however: "We can never say often enough that condoms are the best protection against HIV and other [sexually transmitted infections]…PrEP does not stop other STIs and, as a medicine, is not without adverse events."

PrEP will therefore be available under the RTU "to individuals who cannot, for diverse reasons, use condoms systematically and who belong to groups where HIV incidence is very high."

PrEP prescribing will only be available from HIV specialist physicians within a hospital clinic or HIV testing site, and will include counseling and follow-up.

PrEP will be offered as 2 alternative regimens: daily Truvada for anyone assessed as needing it, but also intermittent PrEP as studied in the Ipergay trial for gay and bisexual men who have frequent condomless sex and do not have chronic hepatitis B infection. The Ipergay regimen consists of a double dose of Truvada 2-24 hours before sex plus 1 dose on each of the following 2 days afterwards, to be continued if condomless sex is continued. The French medicines agency ANSM, which complied to evidence dossier submitted to the Department of Health, comment that the Ipergay did not establish the effectiveness of intermittent PrEP for women (or trans men) or in gay men who have condomless sex only occasionally, and specifically warns against intermittent PrEP in people with chronic hepatitis B as this could cause drug resistance.

Mme Touraine praised the work of the French National HIV Research Organization ANRS, which "had the courage to implement these trials and also the [non-governmental organizations]. Particularly AIDES, which has promoted this tool in the public debate."

Bruno Spire of ANRS is one of the principal investigators of the Ipergay study, whose finding of 86% efficacy for PrEP, along with the English PROUD study, helped convince many that PrEP could be an effective public health tool. He told Aidsmap.com: "This victory is due to the alliance between the French researchers and the HIV community-based movement; Ipergay was an excellent example of doing research not for people, but with people."

Jean-François Delfraissy, the director of ANRS, said: "Marisol Touraine’s decision is of huge significance. It will enable everyone -- health professionals, non-profit organizations, municipal authorities, researchers -- to work together towards…eradication of HIV. This decision should now open the way for the authorization of PrEP in other European countries."

Delfraissy said that implementation research would be conducted on the efficacy of PrEP projects set up in target populations and that PrEP would also be assessed in other vulnerable populations, notably women.

Aurélien Beaucamp, president of AIDES, commented that the decision was the culmination of 3 years of hard work by AIDES, which first proposed an RTU in January 2013, when the Ipergay study had already been running for a year.

"It’s very satisfying to see this initiative succeed," he said. "This means that very soon we will be able to help people across France who need a new prevention tool for their lifestyle. PrEP must be part of an overall strategy to cut the chain of transmission."

"Everyone has a contribution to make to ending the HIV epidemic, including effectively treated people with HIV who no longer transmit," he added. "However only 52% of HIV-positive people in France have an undetectable viral load; many efforts are needed still in France and internationally, and thanks to PrEP we will be better armed to fight the epidemic."

11/24/15