On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection
Jean-Michel Molina
(1)
,
Catherine Capitant
,
Bruno Spire
(2)
,
Gilles Pialoux
(3)
,
Laurent Cotte
(4)
,
Isabelle Charreau
(5)
,
Cecile Tremblay
(6, 7)
,
Jean-Marie Le Gall
(8)
,
Cua Eric
,
Pasquet Armelle
,
Francois Raffi
(9)
,
Claire Pintado
(1)
,
Christian Chidiac
(10)
,
Julie Chas
(3)
,
Pierre Charbonneau
(1)
,
Constance Delaugerre
(11)
,
Marie Suzan-Monti
(2)
,
Benedicte Loze
(1)
,
Julien Fonsart
(12)
,
Gilles Peytavin
(13)
,
Antoine Chéret
(14)
,
Julie Timsit
(12)
,
Gabriel Girard
(15)
,
Nicolas Lorente
(2)
,
Marie Préau
(2)
,
James F. Rooney
,
Mark Wainberg
(16)
,
David Thompson
,
Willy Rozenbaum
(1)
,
Veronique Doré
(17)
,
Lucie Marchand
(17)
,
Marie-Christine Simon
(17)
,
Nicolas Etien
(17)
,
Jean-Pierre Aboulker
(5)
,
Laurence Meyer
(18)
,
Jean Francois Delfraissy
(19)
1
Service de maladies infectieuses et tropicales [Saint-Louis]
2 SESSTIM - U912 INSERM - Aix Marseille Univ - IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
3 CHU Tenon [AP-HP]
4 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
5 Essais Therapeutiques et Infection Par Le Vih
6 Department of Medicine, University of Montreal
7 Centre de recherche
8 Methodology, Innovation, Research, Evaluation (MIRE)
9 CMIT - Collège des Universitaires des Maladies Infectieuses et Tropicales
10 Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL]
11 Laboratoire de virologie
12 AP-HP - Hopital Saint-Louis [AP-HP]
13 Laboratoire de Pharma-Toxicologie
14 Laboratoire de Virologie [CHU Necker]
15 Le Collège d'études mondiales/FMSH
16 McGill University = Université McGill [Montréal, Canada]
17 ANRS France Recherche Nord & sud Sida-hiv hépatites
18 CESP - Centre de recherche en épidémiologie et santé des populations
19 Service de médecine interne et maladies infectieuses
2 SESSTIM - U912 INSERM - Aix Marseille Univ - IRD - Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
3 CHU Tenon [AP-HP]
4 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
5 Essais Therapeutiques et Infection Par Le Vih
6 Department of Medicine, University of Montreal
7 Centre de recherche
8 Methodology, Innovation, Research, Evaluation (MIRE)
9 CMIT - Collège des Universitaires des Maladies Infectieuses et Tropicales
10 Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL]
11 Laboratoire de virologie
12 AP-HP - Hopital Saint-Louis [AP-HP]
13 Laboratoire de Pharma-Toxicologie
14 Laboratoire de Virologie [CHU Necker]
15 Le Collège d'études mondiales/FMSH
16 McGill University = Université McGill [Montréal, Canada]
17 ANRS France Recherche Nord & sud Sida-hiv hépatites
18 CESP - Centre de recherche en épidémiologie et santé des populations
19 Service de médecine interne et maladies infectieuses
Jean-Michel Molina
- Fonction : Auteur
- PersonId : 927383
Catherine Capitant
- Fonction : Auteur
Bruno Spire
- Fonction : Auteur
- PersonId : 21084
- IdHAL : bruno-spire
- ORCID : 0000-0002-3546-8020
- IdRef : 09825846X
Cecile Tremblay
- Fonction : Auteur
Jean-Marie Le Gall
- Fonction : Auteur
- PersonId : 861561
Cua Eric
- Fonction : Auteur
Pasquet Armelle
- Fonction : Auteur
Francois Raffi
- Fonction : Auteur
- PersonId : 931385
Claire Pintado
- Fonction : Auteur
- PersonId : 948183
Christian Chidiac
- Fonction : Auteur
- PersonId : 1062515
Pierre Charbonneau
- Fonction : Auteur
- PersonId : 903096
Marie Suzan-Monti
- Fonction : Auteur
- PersonId : 21154
- IdHAL : marie-suzan-monti
- ORCID : 0000-0003-2507-2863
- IdRef : 253119545
Benedicte Loze
- Fonction : Auteur
- PersonId : 948187
Gabriel Girard
- Fonction : Auteur
- PersonId : 181239
- IdHAL : gabriel-girard
- ORCID : 0000-0001-9756-0458
Nicolas Lorente
- Fonction : Auteur
- PersonId : 765490
- ORCID : 0000-0003-0952-8031
- IdRef : 13629829X
Marie Préau
- Fonction : Auteur
- PersonId : 171105
- IdHAL : preau-marie
- ORCID : 0000-0002-6239-1671
- IdRef : 084340525
James F. Rooney
- Fonction : Auteur
Mark Wainberg
- Fonction : Auteur
- PersonId : 959334
David Thompson
- Fonction : Auteur
- PersonId : 939173
Willy Rozenbaum
- Fonction : Auteur
- PersonId : 948188
Jean-Pierre Aboulker
- Fonction : Auteur
- PersonId : 912316
Laurence Meyer
- Fonction : Auteur
- PersonId : 756223
- ORCID : 0000-0001-5707-2062
- IdRef : 077686659
Résumé
Background Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.MethodsWe conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections.ResultsOf the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03).ConclusionsThe use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.)
Domaines
PsychologieFormat du dépôt | Notice |
---|---|
Type de dépôt | Article dans une revue |
Résumé |
en
Background Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.MethodsWe conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections.ResultsOf the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03).ConclusionsThe use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.)
|
Titre |
en
On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection
|
Auteur(s) |
Jean-Michel Molina
1
, Catherine Capitant
, Bruno Spire
2
, Gilles Pialoux
3
, Laurent Cotte
4
, Isabelle Charreau
5
, Cecile Tremblay
6, 7
, Jean-Marie Le Gall
8
, Cua Eric
, Pasquet Armelle
, Francois Raffi
9
, Claire Pintado
1
, Christian Chidiac
10
, Julie Chas
3
, Pierre Charbonneau
1
, Constance Delaugerre
11
, Marie Suzan-Monti
2
, Benedicte Loze
1
, Julien Fonsart
12
, Gilles Peytavin
13
, Antoine Chéret
14
, Julie Timsit
12
, Gabriel Girard
15
, Nicolas Lorente
2
, Marie Préau
2
, James F. Rooney
, Mark Wainberg
16
, David Thompson
, Willy Rozenbaum
1
, Veronique Doré
17
, Lucie Marchand
17
, Marie-Christine Simon
17
, Nicolas Etien
17
, Jean-Pierre Aboulker
5
, Laurence Meyer
18
, Jean Francois Delfraissy
19
1
Service de maladies infectieuses et tropicales [Saint-Louis]
( 25884 )
- 1, avenue Claude-Vellefaux 75010 Paris
- France
2
SESSTIM - U912 INSERM - Aix Marseille Univ - IRD -
Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale
( 540465 )
- Faculté de Médecine - Site Timone - 27 Bd Jean Moulin 13385 – Marseille Cedex 05
- France
3
CHU Tenon [AP-HP]
( 328304 )
- 4 Rue de la Chine, 75020 Paris
- France
4
UNICANCER/CRCL -
Centre de Recherche en Cancérologie de Lyon
( 139829 )
- 28, rue Laennec - 69373 Lyon
- France
5
Essais Therapeutiques et Infection Par Le Vih
( 2794 )
- Centre de Recherche Inserm PARIS XI 16, Avenue Paul Vaillant-Couturier 94807 VILLEJUIF CEDEX
- France
6
Department of Medicine, University of Montreal
( 463223 )
- Canada
7
Centre de recherche
( 180471 )
- Montréal
- Canada
8
Methodology, Innovation, Research, Evaluation (MIRE)
( 158641 )
- Pantin-Cedex
- France
9
CMIT -
Collège des Universitaires des Maladies Infectieuses et Tropicales
( 459392 )
- France
10
Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL]
( 203644 )
- Hôpital de la Croix-Rousse 93 grande rue de la Croix-rousse 69004 Lyon
- France
11
Laboratoire de virologie
( 236059 )
- Paris
- France
12
AP-HP -
Hopital Saint-Louis [AP-HP]
( 506757 )
- 1 Avenue Claude Vellefaux, 75010 Paris
- France
13
Laboratoire de Pharma-Toxicologie
( 453492 )
- Paris
- France
14
Laboratoire de Virologie [CHU Necker]
( 59545 )
- 149, rue de Sèvres 75743 PARIS Cedex 15
- France
15
Le Collège d'études mondiales/FMSH
( 186475 )
- Fondation Maison des sciences de l'homme 190 avenue de France 75013 Paris
- France
16
McGill University = Université McGill [Montréal, Canada]
( 134741 )
- 845, rue Sherbrooke O. Montréal (Québec) Canada H3A 0G4
- Canada
17
ANRS France Recherche Nord & sud Sida-hiv hépatites
( 300028 )
- France Recherche Nord & sud Sida-hiv hépatites
- France
18
CESP -
Centre de recherche en épidémiologie et santé des populations
( 106188 )
- 16 avenue Paul Vaillant Couturier 94807 Villejuif Cedex, France
- France
19
Service de médecine interne et maladies infectieuses
( 33891 )
- Le Kremlin-Bicêtre
- France
|
Page/Identifiant |
2237-2246
|
Langue du document |
Anglais
|
Nom de la revue |
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Audience |
Internationale
|
Date de publication |
2015
|
Volume |
373
|
Numéro |
23
|
Domaine(s) |
|
Mots-clés |
en
HIV, Preexposure Prophylaxis, prevention
|
DOI | 10.1056/NEJMoa1506273 |
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