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N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

Collaborators (650)

Grant R, McMahan V, Abdel-Mohsen M, Amico KR, Atchison R, Aurigemma M, Bragg L, Defechereux P, Eden C, Gagnon J, Goicochea P, Hance R, Javier J, Lee J, Levy V, Liegler T, McConnell J, Mehrotra M, Monroe-Wise A, Robles M, Schmidt T, Smith L, Stephenson S, Lama J, Vargas L, Alvarado C, Anton C, Bacilo W, Ballesteros L, Barbieri M, Chamochumbi J, Chavez S, Christen C, Cohen M, Diaz J, Egoavil R, Fajardo N, Flores R, Galvez V, Gilvonio J, Gonzales M, Gonzales M, Gonzales P, Grados E, Grant-Villegas N, Guevara M, Gutierrez R, Hernandez A, Huayhua F, Huerta C, Jacome L, Leon R, Llancare M, Llican P, Lozano K, Magallanes Y, Mamani M, Martinez K, McRae J, Mendoza Y, Meneses V, Mercado W, Morales C, Morales M, Mosquera C, Novoa J, Olortegui E, Orihuella J, Pablo K, Pachas R, Peinado J, Perez E, Porcille C, Portal G, Reque J, Rios A, Rios J, Rojas C, Rojas E, Romero C, Ruiz E, Sanchez H, Sanchez M, Seminario L, Soto R, Ticse C, Tirado M, Tume S, Vargas R, Vargas Y, Velasquez C, Vergara J, Zegarra P, Guanira JV, Ramirez ME, Aoki N, Brandes P, Calderon J, Callirgos C, Caro H, Castillo L, Castillo R, Castro L, Centenaro J, Cevallos O, Chang C, Del Castillo M, Dextre J, Diaz A, Espinoza J, Estacio J, Farfan M, Flores D, Galvez V, Ganoza C, Garcia N, Garrido M, Guerra O, Guevara ME, Huisa M, Ibañez G, Izquierdo I, Jimenez A, Juarez J, Jurupe J, Kochiu S, Lacherre M, Mantilla P, Mejia G, Meneses M, Minaya S, Mispireta S, Negron R, Noda N, Ojeda J, Padilla I, Palomino E, Peceros A, Piña P, Popuche D, Quijano E, Quino A, Quispe I, Quispe L, Ramirez B, Ramos E, Rojas G, Rojas P, Rosas G, Rosas R, Salinas C, Salinas M, Salvatierra J, Sanchez C, Sanchez L, Sanchez P, Sosa K, Soto J, Suarez Mdel C, Talaverano A, Tataje A, Tirado R, Troncos G, Urday R, Velarde E, Verastegui M, Villanueva K, Ygnacio E, Ynguil M, Casapia Morales WM, Baldeon Rios JL, Alva Montoya A, Alva Salas E, Alvarado Alvarado D, Antinori Jaen KI, Ayapi Vasquez NF, Barboza Pizango N, Bernuy Heigghen I, Calixtro Callan MA, Carbonel Villanueva KN, Casapia Morales C, Celis Estela J, Chauca Rosas M, Correa Cajachagua F, Da Costa Ahuite KK, del Castillo Panduro A, Diaz Diaz E, Estrella Grandez G, Fasabi Irarica RR, Flores Mayta AK, Garay Quiñones J, Garces Pimentel Fde M, Gomez Garcia A, Guarniz D'orazi DA, Guedes Cacique R, Guerrero Anton P, Hinojosa Boyer JC, Hoyle Ganoza LR, Huarmiyuri Zambrano A, Long Campos Y, Lopez Diaz C, Lopez Yumbato JJ, Lozano Pilco P, Maca Dávila R, Macedo Pinedo MM, Malqui Espino CA, Marin Lizarraga J, Marin Gonzales S, Medina Rengifo L, Montalvan Sandoval E, Najar Rengifo R, Navarro del Aguila I, Noronha Gomez A, Olortegui Pezantes LM, Ortiz Torres O, Panaifo Vela Rdel P, Panduro Babilonia J, Paniagua Yumbato D, Parraguez de la Cruz J, Peixoto Valdez JO, Pereyra Otrera A, Perez Ledesma D, Perez Torres I, Pezo Flores R, Puray Chavez M, Querevalu Zapata M, Quispe Churata P, Reategui Vásquez L, Reategui Tobler M, Rimachi Quiroz A, Rojas Flores C, Romero Guimack J, Ruiz Hidalgo F, Saavedra Sevillano L, Sanchez Lozano K, Sandoval Vega J, Santana C, Siche Martinez JC, Solignac Ruiz N, Tapullima Sangama A, Tapullima Upiachihua R, Tello De la Puente A, Tello Herrera JE, Tello Freitas W, Torres Barata B, Urday Ruiz B, Vela Vela C, Zevallos Molano E, Montoya-Herrera O, Fernández Cadena TE, Galarza Hinojosa LF, Abarca Caceres GR, Alava Ruiz MA, Alvarado Palma AE, Alvarado Palma RG, Alvarez Crespo VE, Andrade Teran JM, Arias Zambrano ND, Aviles Cerezo BE, Aviles Ronquillo OJ, Bajaña Granja WG, Carchipulla Almeida RJ, Casal Cabrera AM, Chicaiza Naula AM, Diaz Moran JA, Diez Pingel LR, Esparza Sarango AJ, Franco Acebo AF, García Noboa Mde L, Guiracocha Aquino LE, Heleno Reina RA, Jarrín Alvarez AA, Loor Alcivar AI, Magallanes Mansaba DD, Mattos Mattos WM, Menendez Andrade AA, Miranda Vera WR, Montaleza Tomala WH, Montero Vidal SC, Ordinola Valdiviezo JM, Palomino Alaus IC, Parrales Saldarriaga OE, Quinga Medina RM, Rivadeneira Velasco JW, Romero Barzola GA, Rosado Rodriguez DJ, Salazar Luna CM, Salinas Salinas Sdel C, Segura Alvarado DA, Suarez Luque JL, Vargas Humanante EP, Vinces Asqui HS, Yonfa Mejia JR, Zambrano Zambrano Mdel C, dos Santos VG, Freitas Lde A, de Almeida MV, de Almeida RH, Alves CA, Amaral DM, Armesto SC, Baeta Dde C, Barreto DF, Barros MB, Camacho LR, Cardoso Edos S, Cardoso SW, de Carvalho PG, de Castro CR, Cavalcanti Wde A, Cordeiro Ddos S, da Costa MD, Fernandes NM, Noé Filho M, França AN, Freitas Jda S, Friedman RK, Gama Kde S, George I, Gonzales ML, Grinsztejn B, Guimarães MR, Hoagland BR, Krstic T, Leitão FM, Lessa FC, Marques SR, Milan RC, do Monte HA, Moreira RI, Murta FC, Neto Jdos S, Neves Junior I, Nogueira Sde O, Oliveira FS, de Oliveira MS, Pedrosa Md, Pessanha ES, Ribeiro VR, de Sá MA, Salgado LS, dos Santos AP Jr, dos Santos JM, dos Santos TA, Senna JR, da Silva AM, da Silva CC, da Silva SR, da Silva VO, de Souza AL, de Souza HE, de Souza LA, de Souza LH, de Souza MN, de Souza UP, de Souza Junior WJ, Torres TS, Schechter M, de Souza MB, Yoshida CB, de Aguiar DF, Alves FB, Branco KV, Brazil JC, Camara DD, da Costa MD, Faulhaber JC, Ferreira SB, Franco R, Gama PS, Garrido RQ, Hammes PC, Hernani F, Januário RJ, de Jesus Junior SC, Leal Nda S, Melo Mde F, da Silva Neto DG, Pedrosa JM, Pimentel LB, Pires Gda C, Ramos FL, Reis Ada M, Sampaio A, dos Santos AO, da Silva AJ, da Silva JR, Tebet NN, Teixeira Bde O, Telles SR, Villard M, Weinstein AL, Kallás EG, Palacios R, Araújo JA, Avelino-Silva VH, Batista AP, Bertevello D, Comello F, Correa LM, Costa PR, Dantas MC, Franco Dde L, Gambôa R, Giret MT, Menezes e Gonçalves DC, Kalil J, Kondo KT, Leal FE, Litvoc M, Maciel Ada S, Magalhães LC, Marques MH, Mathias A, de Medeiros EA, Miraglia JL, Nakagawa ZM, Paro AH, Pennachin F, Pinheiro AM, Rebelo R, Russo RT, Saraiva A, Sauer MM, Silva IM, Tarosso LF, Tomiyama H, Buchbinder S, Liu A, Gilmore HJ, Murphy K, Adams C, Arista P, Asencios JC, Blue R, Carroll S, Colvano S, Cook A, Day E, Diaz A, Faber E, Farley J, Fields S, Fuchs J, Funk S, Futeral A, Goldman M, Grant S, Holland S, Huffaker S, Irby R, Jones T, Joseph C, Koester A, Lam J, Langdon R, Levi M, Liu-Bell C, Lubensky D, Lucas L, Malloy D, Martin B, Martin Q, Matheson T, Moore C, Morrow-Hall G, Nalos AD, Nehira J, O'Campo J, Perez B, Perkins C, Quinones R, Sera R, Silberman S, Soto M, Teague A, Temelso T, Van B, White J, Wong DN, Ycasas JC, Mayer K, Chianese C, Trufant J, Alinsug C, Box M, Cole SL, Dargon J, Dunham E, Fallon M, Gelman M, Lao S, Marquez V, Maynard J, Miele R, O'Brien W, Panther L, Pechukas A, Ripton J, Rogers S, Tu D, Vanderwalker R, Chariyalertsak S, Saokhieo P, Nimsakul S, Boursuk K, Bunsoy P, Chariyalertsak C, Charuwat C, Chotirosniramit N, Chunpen K, Dokuta S, Guarnacci T, Jaithapeang K, Jongpaijitsakul P, Kaewkosaba C, Kaewpoowat Q, Kaibuddhiwat M, Keawvichit R, Ketdechar P, Khamdam P, Koottathep S, Kosashunhanan N, Kosashunhanan N, Larplertsakul A, Linpisarn S, Maneerat S, Manoyos V, Namwongprom S, Nonraban T, Panyawong P, Pasawad W, Phutthitada R, Rungruengthanakit K, Somnoi P, Songsupa R, Sroysuwan P, Sugandhaveha P, Supindham T, Techajal T, Thetket S, Tunjalern S, Tuntivate P, Visrutaratna S, Waropassagone G, Wongsrithep S, Wongthanee A, Wongworapat K, Wonkulab P, Yangnoi A, Yiamwanichaphong M, Bekker LG, Chodacki P, Scheibe A, Batist E, Frieslich H, Hosken C, Brown B, Burrell E, Farrow M, Forune N, Gcwabe L, Heiberg C, Hoffman C, Kanyemba B, Killa N, Kocsis K, Macclachla M, Machlachlan, Mannie S, Margeman A, Mark D, Mkangel M, Ndevu S, Ndobongwana C, Ndzuzo D, Nelson B, Panda B, Peters A, Qumaba M, Snyder K, Stuurman B, Fields S, Glidden D, Manzo J, McCulloch C, Mulligan K, Page K, Shiboski S, Wang F, Ahn T, Annis J, Browne L, Callies B, Carlson E, Chen D, Coblentz D, Houx P, Huff B, Larson B, Marshall T, McDonnell P, Olsen C, Ondrejcek L, Pahl D, Plusquellec S, Post J, Postle B, Prencipe J, Radkey G, Shea T, Shelhorn P, Sims A, Tran A, Van Dalfsen D, Zhang B, Bischofberger N, Clark R, Habr A, Jaffe H, Martin JC, Pfister S, Poblenz M, Rooney JF, Said F, Wulfsohn M, Young W, Burns D, Castillo B, Chow G, Csedrik J, Dieffenbach C, Dixon DO, Fanning M, Kouda A, Martinez A, Mathias C, O'Callahan M, Payton M, Proschan M, Ruiz M, Sharma U, Smith B, Zwerski S, Ferinde J, Putta N, Becker S, Eakle R, Ridzon R, Sakrison K.

Author information

  • 1J. David Gladstone Institutes, University of California at San Francisco, 1650 Owens St., San Francisco, CA 94158, USA. robert.grant@ucsf.edu

Abstract

BACKGROUND:

Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.

METHODS:

We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections.

RESULTS:

The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57).

CONCLUSIONS:

Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

Comment in

PMID:
21091279
[PubMed - indexed for MEDLINE]
PMCID:
PMC3079639
Free PMC Article

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