Treatment taken at the time of sexual relations reduces the

Treatment taken at the time of sexual relations reduces the risk of
HIV infection by almost 90%
Press release
1 December 2015
Today on World AIDS Day 2015, Professor Jean-Michel Molina (Hôpital Saint-Louis, Assistance Publique–
Hôpitaux de Paris and Université de Paris Diderot) and the ANRS IPERGAY team have published online
in the New England Journal of Medicine results that underscore the great effectiveness of PrEP—a
strategy for preventing HIV infection—in men who have sex with men, who are at high risk of such
infection. Taken at the time of sexual relations, this prophylactic treatment reduces the risk of HIV
infection by 86%. The publication of this study follows the French Minister of Health’s decision to
authorize access to this treatment in France.
The condom is the cornerstone of the prevention of sexually transmitted diseases, but cannot always
be used in all circumstances. Over two million people worldwide were newly infected by HIV in 2014
and more than 6000 cases of HIV infection are discovered every year in France, so there is an urgent
need for new means of prevention. One serious avenue of research since 2010 has been preexposure
prophylaxis, or PrEP, in which HIV-uninfected individuals take preventive antiretroviral treatment.
Men who have sex with men (MSM) constitute the population most affected by HIV infection in the
developed countries, and in France they account for 43% of all new cases. In 2010 the iPrEx study was
the first randomized double-blind trial (one group of volunteers receives an active drug and the other
group is given a placebo) to show that PrEP is effective in MSM: daily intake of Truvada®, a fixed-dose
combination of the oral antiretrovirals tenofovir and emtricitabine (TDF-FTC), reduced the risk of HIV
infection by 42%. Most trials conducted since in heterosexual men and women and in drug users have
shown that the efficacy of this treatment is contingent upon adherence. In other words, if the
treatment is not taken every day, its preventive effect is lost.
Professor Jean-Michel Molina (Hôpital Saint Louis, Assistance Publique–Hôpitaux de Paris and Université
de Paris Diderot) and the ANRS IPERGAY team report today in the New England Journal of Medicine
the highest efficacy of PrEP ever observed in a randomized trial. The ANRS IPERGAY study has furnished
the first scientific evidence that on-demand preventive treatment taken at the time of sexual relations
reduces by 86% the risk of HIV infection in MSM who do not always have protected sex (ie, use a
condom).
Coordinated and funded by the ANRS, the ANRS IPERGAY study is based on the assumption that an
on-demand treatment taken at the time of sexual relations would favor adherence. Such a preventive
approach could also reduce possible side effects and limit the cost of treatment.
The ANRS IPERGAY study is being conducted in several clinical centers in France and Canada (Paris:
Hôpital Saint-Louis and Hôpital Tenon, AP-HP. Lyon: Hôpital de la Croix-Rousse. Nantes: CHU Hôtel Dieu.
Nice: Hôpital de l’Archet. Tourcoing: Hôpital Gustave Dron. Canada: CHUM de Montréal), with the
active participation of the community organizations AIDES in France and REZO in Canada, the ANRS,
research units, and Inserm SC10. ANRS is the sponsor and main source of funding for this study. Other
funding bodies are the Bill & Melinda Gates Foundation, the Fonds de dotation Pierre Bergé, the CIHR
Canadian HIV Trials Network, and Gilead Sciences Inc.
In this randomized trial started in 2012, 400 MSM at high risk of HIV infection were divided into two
groups, one taking TDF/FTC at the time of sexual relations and the other taking a placebo. All
participants were given personalized advice on prevention at each medical visit by members of AIDES
and REZO, were provided with condoms and gel lubricant, and underwent repeated screening for HIV
infection and other sexually transmitted diseases, followed by treatment if necessary. Hepatitis B and A
vaccine was routinely offered to participants and HIV post-exposure prophylaxis was made available.
Sixteen HIV infections occurred during the mean 9.3 months of follow-up: 2 in the TDF/FTC group and 14
in the placebo group. It transpired that the 2 men infected in the TDF/FTC group had interrupted
treatment several weeks before infection. Study participants took a median of 15 tablets (TDF/FTC or
placebo) per month. The rate of adverse events was similar in the two groups.
When the first results of this study were presented at the Conference on Retroviruses and Opportunistic
Infections (CROI) on 24 February 2015, Professor Jean-François Delfraissy, Director of ANRS, said: “The
ANRS IPERGAY study constitutes an undeniable step towards a better overall prevention strategy
comprising various tools designed to limit the risk of infection as a function of the degree of exposure.”
Results from the PROUD study in the UK (open-label randomized trial of prophylactic treatment with
one tablet of TDF/FTC daily) published in The Lancet in September 2015 showed the same level of
efficacy as in the ANRS IPERGAY study, thus opening a new page in the history of the fight against
HIV/AIDS.
Lead author Professor Jean-Michel Molina noted that: “The results of the ANRS IPERGAY Study show us,
on the one hand, that the risk of HIV infection is very high in these at-risk populations in France and
Canada, and, on the other hand, that on-demand PrEP greatly reduces this risk, thus justifying its
implementation as a new means of preventing HIV infection.”
The scope of this research has been recognized by the World Health Organization, which in its
September 2015 Guideline on when to start antiretroviral therapy and on preexposure prophylaxis for
HIV recommends for the first time that PrEP be used “as an additional means of prevention for people
at substantial risk of HIV infection as part of combination prevention approaches.” In France, the
Minister of Health has just authorized the use of PrEP and the reimbursement of its cost for those people
most at risk of HIV infection. A new prevention tool is now available and it is up to researchers to assess
its efficacy and its impact on the HIV/AIDS epidemic in real-life conditions.
A multidisciplinary research program is being set up by the ANRS to expedite provision of PrEP. The
ANRS IPERGAY Study, which will continue in 2016, should keep yielding essential data on the long-term
efficacy of this preventive treatment, adherence to it, and its impact on the sexual behavior of
volunteers, some of whom have been followed up since 2012.
Scientific contact:
Professor Jean-Michel Molina
Hôpital Saint-Louis – AP-HP
[email protected]
Press contact
ANRS
[email protected]
Source:
Source :
On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. The New England Journal of Medicine,
December 1st.
Jean-Michel Molina, Catherine Capitant, Bruno Spire, Gilles Pialoux, Laurent Cotte, Isabelle Charreau, Cécile
Tremblay, Jean-Marie Le Gall, Éric Cua, Armelle Pasquet, François Raffi, Claire Pintado, Christian Chidiac, Julie Chas,
Pierre Charbonneau, Constance Delaugerre, Marie Suzan-Monti, Bénédicte Loze, Julien Fonsart, Gilles Peytavin,
Antoine Cheret, Julie Timsit, Gabriel Girard, Nicolas Lorente, Marie Preau, James F. Rooney, Mark A. Wainberg, David
Thompson, Willy Rozenbaum, Véronique Dore, Lucie Marchand, Marie-Christine Simon, Nicolas Etien, Jean-Pierre
Aboulker, Laurence Meyer, and Jean-François Delfraissy, for the ANRS IPERGAY Study Group*
From the Departments of Infectious Diseases ( J.-M.M., C.P., P.C., B.L., W.R.) and Sexually Transmitted Diseases ( J.T.),
and the Laboratories of Virology (C.D.) and Biochemistry ( J.F.), Hôpital Saint-Louis, Assistance Publique Hôpitaux de
Paris, Université de Paris Diderot, Sorbonne Paris Cite, INSERM UMR 941, Department of Infectious Diseases, Hôpital
Tenon (G.P., J.C.), Collège des Universitaires de Maladies Infectieuses et Tropicale (F.R.), Laboratoire de Toxicologie
et Pharmacologie, Centre Hospitalier Bichat Claude Bernard (G.P.), Collège d’Etudes Mondiales (G.G.), ANRS
France Recherche Nord et Sud Sida-HIV et Hépatites (V.D., L.M., M.-C. S., N.E., J.-F.D.), Université de Paris Sud,
Kremlin Bicêtre (L.M.), Paris, INSERM SC10 US019, Villejuif (C.Capitant, I.C., J. P.A., L.M.), Department of Medicine,
INSERM UMR 912 SESSTIM, Marseille (B.S., M.S.M., N.L.), Department of Infectious Diseases, Hôpital de la Croix Rousse,
Centre Hospitalier et Universitaire de Lyon (L.C., C. Chidiac), and Groupe de Recherche en Psychologie Sociale EA
4163, University of Lumiere (M.P.), Lyon, Department of Infectious Diseases, Hôpital de l’Archet, Centre Hospitalier de
Nice, Nice (E.C.), Department of Infectious Diseases, Hôpital G. Dron, Centre Hospitalier Universitaire de Tourcoing,
Lille (A.P., A.C.), and Association AIDES, Pantin ( J.-M.L.G.) — all in France; Centre Hospitalier de l’Université de
Montréal (C.T.), Institut de Recherche en Santé. Publique de l’Université de Montréal (G.G.), McGill University AIDS
Centre, Jewish General Hospital (M.A.W.), and Community Organization REZO (D.T.) — all in Montreal; and Gilead
Sciences, Foster City, CA (J.F.R.).