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N Engl J Med. 2016 Dec 1;375(22):2121-2132. Epub 2016 Feb 22.

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women.

Collaborators (851)

Bello ES, Chihana M, Huwa JC, Chisale P, Chithila F, Dadabhai SS, Degnan L, Debevec B, Fatch T, Goliati E, Gondwe DK, Kandonje DH, Kachale E, Kaliwo V, Kamaliza M, Kamanga M, Chadza MK, Soko DK, Kaphiri T, Kumwenda N, Mwenda WL, Madiwati B, Makunganya J, Malemia A, Malidadi M, Maruwo A, Mbilizi YR, Mpofu J, Mulenga P, Mulima J, Munthali J, Mwafulirwa L, Mwakhwawa T, Njete L, Nkanaunena K, Nyirenda M, Phingo M, Phiri G, Seyama L, Simkoza H, Singini I, Singini A, Sitima E, Siyasiya A, Taulo F, Taulo E, Tung'ande T, Zulu F, Baluwa C, Banda G, Banda B, Banda T, Chikopa L, Chindebvu M, Chintedza J, Chinula L, Chitema F, Chitsulo G, Chiudzu G, Chome N, Gondwe N, Hoffman I, Kachipapa E, Kaliati I, Kalulu A, Kamwana G, Kilembe J, Kumwenda M, Kumwenda W, Kumwenda P, Lungu T, Lusewa C, Makala Y, Mapanje C, Mhango W, Mkandawire N, Mkochi T, Msiska E, Msumba L, Mukatipa M, Mwese J, Ndovie M, Nkhalamba T, Nyirenda N, Sichali D, Stambuli H, Tegha G, Tembo T, Tembo T, Atujuna M, Barnabas S, Belonje D, Cengimbo N, Chabanga HA, Coba T, Crida D, Dallimore J, Danster N, Dikili S, Dippenaar R, Dlulane P, Dukwe P, Dyabeni L, Fleurs L, Funda NP, Gelant J, Gogo L, Gumede S, Hlwele N, Hobongwana T, Jeffery L, Jose M, Khaya B, Khumalo T, Killa N, Maclachlan M, Magobiane N, Mahed F, Makhamba P, Malan G, Masters A, Mayekiso N, Mcayiya T, Mngqebisa B, Mona N, Mthethi Z, Nandudu N, Ngayi B, Ngqabe N, Nkomiyapi SM, Nompondwana M, Ntlantsana V, Ntshoko M, Pearce N, Peterson N, Radebe M, Radzilani T, Rainers H, Rasmeni S, Reynolds D, Rode N, Roux S, Scotch N, Snyder K, Temmers N, Thompson C, Tofile T, Tshongoyi N, Van Der Vendt D, Van Niekerk C, Vogt M, Wallace M, Woolley P, Yola N, Young K, Chetty D, Dias L, Dladla M, Gengiah T, Govender M, Harkoo I, Kamal S, Kasaval M, Khan I, Khanyile S, Khwela C, Kubheka L, Luthuli L, Mabasa N, Madlala B, Maharaj B, Mayisela N, Mdunge A, Mkhize W, Mngadi A, Moosa A, Naidoo K, Naidoo A, Ndwandwe L, Ramdhani V, Richards J, Shozi C, Singh C, Zungu N, Abbai N, Arbee F, Ashokumar A, Aungadh A, Baba L, Baboolal S, Balkaran K, Bebeza S, Bhayat H, Bhengu B, Bhengu R, Biyela B, Boodhram R, Bulose P, Buthelezi P, Buthelezi S, Buthelezi S, Buthelezi T, Buthelezi L, Buthelezi P, Buyeye L, Byroo S, Cebisa S, Cele N, Chamane V, Chetty C, Chitray K, Chonco P, Choonilall A, Chunderduri K, Cibane S, Devnarain S, Dhanpal N, Dladla N, Dlamini D, Dlamini E, Dubazane N, Dube F, Duma C, Dwayisa Z, Faya N, Gaffoor T, Ganesh R, Ganesh S, Gappoo S, Gasa T, Gounden N, Govender D, Govender D, Govender M, Govender N, Govender S, Guddera V, Guga P, Gumede E, Gumede S, Harichund C, Haridutt A, Harilal J, Hemchund I, Hlangu P, Hlela T, Hlophe M, Hurbans N, Imamdin R, Jagesur L, Jainarain K, Jenneker M, Jokozela A, Juggernath V, Juggessar N, Kadwa R, Khaba DP, Khalishwayo V, Khanyile L, Khanyile N, Khanyile R, Khomo M, Khoza N, Khubone N, Khumalo N, Khumalo TK, Khuzwayo N, Kistansami G, Kumalo N, Labuschange L, Lembethe P, Mabaso M, Mabaso S, Mabusela P, Sayed F, Maduna P, Magwaza P, Maharaj R, Mahlangeni T, Makeka N, Makhanya N, Makhoba N, Maphumulo L, Maphumulo N, Mavis V, Maphumulo B, Marx E, Masinga N, Mavundla SS, Mbatha T, Mbeje T, Mbeko M, Mbhele S, Mbonambi S, Mbuyisa F, Mchunu M, Mchunu N, Mdepha P, Mdletshe MI, Meyiwa S, Mhlaba N, Mhlongo R, Mhlongo Z, Mkhabela N, Mkhithi L, Mkhize L, Mkhize Z, Mkhize S, Mkhize Z, Mkhize T, Mkhunyo Z, Mkhwanazi N, Mnikathi N, Mnqonywa N, Mofokeng M, Moodley J, Moodley J, Moodley J, Moodley R, Moodley S, Moonsamy S, Morar N, Mphili N, Mpofana I, Mshibe LC, Msomi LD, Msomi S, Msomi T, Msweli S, Mthalane E, Mthembu B, Mthembu F, Mthembu T, Mthethwa NZ, Mthimkhulu S, Mthlane MI, Mvelase S, Mvuyane GZ, Mzimela L, Mzimela N, Mzolo A, Naicker K, Naicker S, Naicker V, Naidoo A, Naidoo S, Naidoo A, Naidoo I, Naidoo J, Naidoo J, Naidoo K, Naidoo S, Naidoo S, Naidu N, Naras A, Nayager T, Ncayiya N, Ndaba N, Ndaba S, Ndala T, Ndamase P, Ndlovu S, Ndlovu Z, Ndlovu J, Ndlovu S, Ndwandwe DE, Ngobese KJ, Ngubane H, Ngubane M, Nhleko S, Nursayhe N, Nxumalo N, Nyawo K, Padayachee K, Paramanund L, Perumal M, Phahlamohlaka B, Phillip J, Pillay J, Pillay O, Pillay P, Pillay T, Pillay Y, Premrajh A, Punianathan R, Qhogwana L, Rajpal P, Ramdass S, Ramluckan N, Ramnarain S, Rampersadh A, Ramsumair R, Ratanjee A, Reddy M, Reddy M, Reddy N, Reddy T, Sakloo V, Saul N, Shangase S, Shazi Z, Shembe Z, Shobede Z, Sibisi S, Sibisi T, Sibiya Z, Singh N, Sithole H, Sithole L, Skhosana M, Soobryan D, Spooner E, Sukazi S, Teise R, Tenza T, Tshabalala T, Tutshana B, Udith A, Vallabhjee L, Vijay A, Vilakazi H, Viriah B, Wanda B, Woeber K, Zondi T, Zulu T, Zungu N, Zungu P, Zwane I, Boikanya R, Bojosi P, Bothma R, Cebekhulu B, Cohen S, Delany-Moretlwe S, Diep L, Dott C, Duba NG, Dube NM, Duma PI, Farisani LML, Gama L, Gegana NM, Govender N, Gubayo S, Gumede N, Guness MP, Hoggan MA, Kekana E, Kgaritsi MD, Khan F, Langa T, Madi MM, Maduno N, Maenetje PW, Magazi B, Maila ML, Makgoka KP, Makupula BS, Manzingana NN, Maputla F, Maraba MC, Martin R, Marule ES, Maseko N, Maseko P, Mashabane N, Mashiane TE, Mathebula FT, Mathipa M, Matikinca XJ, Mazibuko NV, Mlangeni EG, Mlotshwa MD, Mnguni B, Modau M, Modise CL, Mokgatle KM, Mokoena ET, Mothle AO, Mthethwa MJ, Mthalane ES, Mzolo ADN, Nage E, Naidoo AD, Naidoo MA, Naidoo S, Ncgobo NLE, Ncube DE, Ndhlozi TW, Ngcobo NT, Ngoetjana J, Ngozo R, Ngwenya LP, Nhlapo D, Nkangane L, Nyathi AT, Okwuolise OV, Palanee-Phillips B, Pamacheche P, Pitso ST, Ramafalo MP, Ramalo P, Ramchuran P, Reddy K, Rees VH, Sharif A, Sibeko SS, Sibisi S, Sibisi WP, Sizane V, Steingo J, Stuurman R, Thobejane LP, Tjale LC, Tshabalala M, Verheyden B, Vuma AC, Aanyu D, Akello CA, Asiimwe P, Biira FA, Balamusani D, Bazira JA, Bihabwa G, Birungi E, Bolton S, Bukenya LE, Nabatanzi RB, Sseguya BB, Busuulwa BJ, Elbireer A, Ongom JE, Fowler MG, Mirembe BG, Ggita J, Juuko A, Kizza DK, Kabwigu S, Kafufu B, Mukasa AK, Kagoda J, Kakayi BC, Nabunya HK, Kamira B, Kampi R, Kamugisha A, Kamya J, Bawulira FK, Karugaba P, Katongole F, Kemigisha D, Kiiza B, King B, Kintu K, Sserwadda HL, Lwanga J, Musoke PM, Makooka H, Mayanja E, Mbabali MS, Mirembe D, Motevalli MO, Mubiru MC, Namayanja PM, Mugenyi M, Najjemba MMK, Musisi M, Mutebo J, Muwawu R, Mwebaza D, Nabisere J, Nabukeera J, Kiwanuka CVN, Najjuka S, Nakacwa S, Nakakande J, Nakalema MG, Saava MN, Nakibuka J, Nakyanzi T, Nakyeyune J, Kalungi SN, Namirembe C, Nampewo J, Nkalubo SN, Nankinga S, Nansamba W, Nanyonga S, Nanziri SC, Kawuma CN, Ndawula P, Nolan M, Musisi JN, Nyanzi Z, Wabwire DO, Ojok D, Onen F, Onyuthfua M, Osman S, Onyango CP, Rwanzogyera G, Sakwa R, Semakula J, Kikonyogo FS, Ssenyonga M, Zalwango A, Bafana Munatsi TNS, Banda M, Chandipwisa A, Chareka GT, Chasakara CZ, Chidemo T, Chigwanha D, Chihota E, Chikono S, Chikonyora A, Chikuni A, Chitambo T, Chitsinde C, Chitukuta M, Chivasa T, Dhlakama PM, Godo L, Gomani P, Goreraza R, Gwete NS, Hlahla K, Hunidzarira P, Hwehwe TD, Kachingamire F, Katanda C, Katema H, Kufakunesu T, Kundeya M, Kutinyu I, Madovi T, Magure TM, Makaya TC, Makoni R, Makwenda S, Mangove LZ, Manyeruke T, Mapfunde A, Maponga CEC, Masango M, Masara TB, Masawi M, Masuko S, Matanhire A, Matenda S, Matsa JM, Matubu AT, Matyanga CMJ, Mhangami F, Mhizha ES, Mlingo M, Mlingo CT, Motsi TM, Mpofu TAM, Mugocha C, Mugodhi F, Mugowe N, Muhlanga FGS, Mukaka S, Mukova S, Munaiwa O, Munjoma MW, Mupunga M, Murefu T, Murewanhema G, Musara P, Mutero P, Mutisi F, Muvunzi T, Muzamhindo TRL, Mwakurudza S, Mwandiwata E, Ncube S, Ncube E, Ndadziyira P, Ndhlovu G, Ngwindi E, Nyabadza O, Nyakudya S, Nyawera EC, Rimau F, Rupondo N, Rushwaya C, Samaneka LN, Shawatu BN, Shonhiwa R, Tauya TT, Thompson M, Vuta C, Zinyongo M, Aridor O, Bezak L, Comer K, Conser E, DeGore M, Duran L, Foster M, Leszczewski M, McCarthy K, Rossi L, Rullo C, Smolinski D, Browning-Roberts B, Maddox T, Montoya D, Moutsos K, Scoville C, Calabrese K, Cokley C, Friedland I, Mierzwa S, Souidi S, Wu C, Cheng H, Hartmann M, Katz A, Laborde N, Leslie J, Lutnick A, Pleasants E, Shapley-Quinn MK, Johnson J, Manohar M, Seserko L, Travers J, Austin M, Avolia H, Beamer M, Cosentino L, DeMarco A, Dezzutti C, Hall W, Hendrickson S, Jones L, Petrina M, Rabe L, Stoner K, Hamanishi K, Eskay K, Gordon K, Halvas E, Hardesty R, Opest A, Penrose K, Abullarade J, Anderson M, Balkus J, Bassuk D, Borgerding J, Chapdu C, Chin C, Cianciola M, DeBoer C, Dinnie E, Doyle M, Edwards D, Fitzpatrick J, Gandham S, Huang H, Kentop S, Krause J, Liu K, Mohebalian I, Molitor C, Pan J, Schille J, Snapinn K, Tseng J, Unten C, Weaver K, Wilson D, Adedeji B, Black R, Barnett R, Bupp J, Chow G, Cleland N, Cogliano N, Csedrik J, Dieffenbach C, Erbelding E, Estep S, Freeman L, Hinds J, Martinez A, O’Brien J, Payton M, Perez A, Piper J, Potter D, Rancourt A, Rausch D, Russo D, Saint-Vil D, Sharma U, Siskind R, Leirman LS, Stover K, Towers S, Veronese F, Zwerski S, Carstens H, Carter A, Derrick T, Devlin B, Garg A, Malherbe M, Mans W, Nuttall J, Russell M, Seaton E, Solai L, Spence P, Steytler J, van Niekerk N, Windle K, Bhengu N, Bucklew R, Chasakara C, Chatani M, Dlamini C, Dlamini T, Gondwe D, Kampangire Z, Katana M, Luthuli V, Mafumane O, Mchunu Z, Mthiyane T, Muganga J, Ndlovu Z, Ngani S, Ngqame S, Nkebi JC, Nompondwana M, Samuels H, Sontshatsha B, Wright T, Zindela A, Cates W, Celum C, Donnell D, Hughes J, McCormack S, Wang L.

Abstract

BACKGROUND:

Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection.

METHODS:

We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe.

RESULTS:

Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups.

CONCLUSIONS:

A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096 .).

PMID:
26900902
PMCID:
PMC4993693
DOI:
10.1056/NEJMoa1506110
[Indexed for MEDLINE]
Free PMC Article

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