High efficacy of on-demand pre-exposure prophylaxis confirmed by final results from ANRS IPERGAY

20 July 2016
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The last phase of ANRS IPERGAY has confirmed that “on-demand” pre-exposure prophylaxis (PrEP) is a highly effective method of reducing the risk of HIV infection in men who have sex with men and who report high-risk behavior. These results will be presented at AIDS 2016 in Durban, South Africa (18 to 22 July). From late 2016, a vast research program, ANRS PREVENIR, will assess PrEP on a large scale in Paris and its suburbs (France).

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Reducing the number of new infections in populations particularly affected by HIV is more than ever a public health priority recognized by international institutions and by most developed and resource-limited countries. Pre-exposure prophylaxis, or PrEP, in which preventive antiretroviral therapy is offered to people not infected by HIV, is a new approach that is being implemented in several towns mainly in the United States, and will soon be in Europe. Paris will be the first European capital to launch an ambitious program of PrEP designed to reduce new infections in the groups most at risk.

These advances in prevention are based on clinical trials, in particular on the findings of two studies: PROUD, in England, and ANRS IPERGAY1, a French-Canadian study conducted with HIV-AIDS community organization AIDES. ANRS IPERGAY is a study of “on-demand” PrEP at the time of exposure to the risk of HIV infection among seronegative men who have sex with men (MSM) and who reported at-risk behavior in the six months prior to inclusion. Started in 2012, the first phase of ANRS IPERGAY was conducted double-blind (half the group took an oral antiretroviral combining TDF and FTC [Truvada®] at the time of sexual relations, the other half took a placebo). It showed that Truvada® reduced the risk of HIV infection by 86% (Molina et al. New England Journal of Medicine Dec 3, 2015).
 

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Final results
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Once these findings became available in November 2014, ANRS IPERGAY entered its second and last phase: all participants were given Truvada®. The aim was to ensure the benefits of “on-demand” PrEP and its long-term safety and to assess its impact on sexual behavior. Professor Jean-Michel Molina (Hôpital Saint-Louis, AP-HP, Université Paris Diderot, Paris, France) presents in an oral communication the final results of this last, “open-label” phase at AIDS 2016 in Durban, South Africa (18-22 July). Dr Bruno Spire (lnserm U912-Sesstim, Marseille, France) will complete the picture by reporting an analysis of sexual behavior.

The results of the follow-up between November 2014 and June 2016 in 362 volunteers (333 who participated in the randomized phase + 29 new recruits) presented today are even more

1 ANRS IPERGAY was conducted in close collaboration with HIV-AIDS community organization AIDES, which participated actively in the recruitment of volunteers and provided them with prevention support throughout the trial, which was conducted in Paris (Hôpital Saint-Louis et Hôpital Tenon, AP-HP), Lyon, Nice, Tourcoing, and Nantes, as well as in Montreal (CHUM) in partnership with the community organization REZO.

remarkable than those of the first phase: a single person, who in fact interrupted PrEP, was infected by HIV in the “open-label” phase. The incidence (the number of new cases) was therefore only 0.19 infections per 100 person-years of follow-up. The incidence in the Truvada® arm during the double-blind phase was 0.91%.

Professor Molina said “The results of the “open-label” phase of the trial confirm the very good efficacy and safety of on-demand PrEP in reducing the risk of HIV infection in high-risk MSM. These results should promote broader use of PrEP in at-risk populations in countries where justified by the epidemic situation.”

Professor Jean-François Delfraissy, Director of ANRS, applauds the French decision taken in late 2015 to authorize PrEP and its reimbursement, by means of a temporary recommendation for use. “The question today is no longer to know whether PrEP is effective and should be used, but rather how to make it available rapidly to the people most at risk.”
 

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Diversified prevention
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Qu’en est-il de l’usage du préservatif, qui reste la pierre angulaire de la prévention contre l’infection par le VIH et les autres infections sexuellement transmissibles ? Une étude sur les comportements réalisée pendant la phase ouverte de l'essai révèle une légère baisse de l’usage du préservatif, en particulier chez les personnes identifiées comme en étant fortement utilisatrices lors de la phase en double aveugle. Cette diminution est compensée dans la grande majorité des cas par le recours à la PrEP. 

« La diminution de l’utilisation du préservatif dans l’essai "en ouvert" n’est pas inquiétante pour l’instant", déclare le Dr Bruno Spire. « Les participants de l’essai étaient sûrs d’être protégés par la PrEP, qu’ils savaient efficace. Il existe cependant une petite minorité de participants n’utilisant ni la PrEP ni le préservatif. Nous devons essayer de comprendre quels sont les freins à la prévention chez ces personnes ». Il ajoute : « Il semble désormais important de parler de prévention diversifiée, où on laisse la liberté de choix, plutôt que de prévention combinée, car il est assez illusoire d’imaginer qu’une majorité de personnes pourront utiliser plusieurs moyens de prévention en même temps.». 

L'ANRS va prochainement lancer un ambitieux programme de recherche opérationnelle qui sera mené en Ile-de-France auprès d’environ 3000 personnes à haut risque d’infection par le VIH (HSH, personnes transgenres, et personnes migrantes principalement). Le projet ANRS PREVENIR vise à réduire le nombre de nouvelles infections par le VIH, et mesurera le bénéfice d’un accompagnement communautaire sur l’observance et le maintien des participants dans la PrEp à long terme. 

 

Abstracts 

Efficacy of on demand PrEP with TDF-FTC in the ANRS IPERGAY open-label extension study 
J.-M. Molina(1,2), I. Charreau(3), B. Spire(4), L. Cotte(5), J. Chas(6), C. Capitant(3), C. Tremblay(7), D. Rojas-Castro(8), E. Cua(9), A. Pasquet(10), C. Bernaud(11), W. Rozenbaum(2), C. Delaugerre(12), V. Doré(13), S. Le Mestre(13), M.-C. Simon(13), J.-F. Delfraissy(13), L. Meyer(3,14), ANRS IPERGAY Study Group.


1) University of Paris Diderot, INSERM UMR 941, Paris, France, 2) Hospital Saint-Louis, APHP, Infectious Diseases Department, Paris, France, 3) INSERM, SC 10-US 19, Villejuif, France, 4) INSERM, UMR 912, Marseille, France, 5) Hospices Civils de Lyon, Infectious Diseases Department, Lyon, France, 6) Hospital Tenon, APHP, Infectious Diseases Department, Paris, France, 7) Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Canada, 8) AIDES, MIRE, Pantin, France, 9) Hospital de l'Archet, Infectious Diseases Department, Nice, France, 10) Hospital Gustave Dron, Infectious Diseases Department, Tourcoing, France, 11) CHU Hôtel Dieu, Infectious Diseases Department, Nantes, France, 12) Hospital Saint-Louis, Virology Department, Paris, France, 13) INSERM-ANRS, Paris, France, 14) INSERM, Paris 11 University, Kremlin Bicêtre, France .


Reported changes in PrEP and condom use in MSM during the open-label extension of the ANRS IPERGAY study 
L. Sagaon-Teyssier(1,2,3), M. Suzan-Monti(1,2,3), D. Rojas-Castro(4), M. Danet(4), N. Hall(5), L. Fressard(1,2,3), M. Di Ciaccio(1,3,6), C. Capitant(7), V. Foubert(7), C. Chidiac(8), V. Doré(9), C. Tremblay(10), J.-M. Molina(11), B. Spire(1,2,3), ANRS IPERGAY Study Group.

1) INSERM, UMR_S 912, Sciences Economiques & Sociales de la Santé et Traitement de l'Information Médicale (SESSTIM), Marseille, France, 2) Aix Marseille Université, UMR_S 912, IRD, Marseille, France, 3) Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France, 4) AIDES MIRE, Paris, France, 5) CHU, Nantes, France, 6) GREPS, Université Lyon 2, Lyon, France, 7) INSERM SC 10 US 19, Villejuif, France, 8) Hôpital de la Croix Rousse, INSERM U 1052, Department of Infectious Diseases, Lyon, France, 9) ANRS, Paris, France, 10) Research Center of the Centre Hospitalier de l'Université de Montréal, Montréal, Canada, 11) Hospital Saint-Louis, Department of Infectious Disease, Assistance Publique Hôpitaux de Paris, Paris, France

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