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.
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
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
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.”