France approves PrEP

In a historic move, France has become the first country outside the USA, and the first country with a centrally-organised, reimbursable health system, to approve no-expense pre-exposure prophylaxis (PrEP) for people who need it.

The French Minister of Health, Marisol Touraine, announced today that PrEP would be available from mid-December, and reimbursable through the French health system from the beginning of January.

The positive recommendation for Truvada (tenofovir/emtricitabine) 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 Authorisation. RTUs are used for drugs that already have Marketing Authorisation for other uses – in this case, for HIV treatment.

Glossary

condomless

Having sex without condoms, which used to be called ‘unprotected’ or ‘unsafe’ sex. However, it is now recognised that PrEP and U=U are effective HIV prevention tools, without condoms being required. Nonethless, PrEP and U=U do not protect against other STIs. 

opportunistic infection (OI)

An infection that occurs more frequently or is more severe in people with weakened immune systems, such as people with low CD4 counts, than in people with healthy immune systems. Opportunistic infections common in people with advanced HIV disease include Pneumocystis jiroveci pneumonia; Kaposi sarcoma; cryptosporidiosis; histoplasmosis; other parasitic, viral, and fungal infections; and some types of cancer. 

drug resistance

A drug-resistant HIV strain is one which is less susceptible to the effects of one or more anti-HIV drugs because of an accumulation of HIV mutations in its genotype. Resistance can be the result of a poor adherence to treatment or of transmission of an already resistant virus.

eradication

The total elimination of a pathogen, such as a virus, from the body. Eradication can also refer to the complete elimination of a disease from the world.

transgender

An umbrella term for people whose gender identity and/or gender expression differs from the sex they were assigned at birth.

Mme. Touraine said: “I am in favour 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 recognised 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 STIs…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 counselling and follow-up.

PrEP will be offered as two alternative regimens: daily Truvada for anyone assessed as needing it, but also intermittent PrEP as studied in the Ipergay trial for MSM 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 one dose on each of the following two days afterwards, to be continued if condomless sex is continued. The French medicines agency ANSM, who complied to evidence dossier submitted to the Department of Health, comment that the Ipergay did not establish the effectiveness of intermittent PrEP in women (or trans men) or in MSM 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 Organisation ANRS “who had the courage to implement these trials and also the NGOs. 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 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 organisations, municipal authorities, researchers – to work together towards…eradication of HIV. This decision should now open the way for the authorisation of PrEP in other European countries.”

He said that implementation research would be conducted into 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 three years of hard work by AIDES, who 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. 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.”