Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women

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dc.contributor.author Nel, A.
dc.contributor.author Van Niekerk, N.
dc.contributor.author Kapiga, S.
dc.contributor.author Bekker, S.-G.
dc.contributor.author Gama, C.
dc.contributor.author Kamali, A.
dc.contributor.author Kotze, P.
dc.contributor.author Louw, Cheryl
dc.contributor.author MAbude, Z.
dc.contributor.author Miti, N.
dc.contributor.author Kusemererwa, S.
dc.contributor.author Tempelman, H.
dc.contributor.author Carstens, H.
dc.contributor.author Devlin, B.
dc.contributor.author Isaacs, M.
dc.contributor.author Malherbe, M.
dc.contributor.author Mans, W.
dc.contributor.author Nuttall, J.
dc.contributor.author Russell, M.
dc.contributor.author Ntshele, S.
dc.contributor.author Smit, M.
dc.contributor.author Solai, L.
dc.contributor.author Spence, P.
dc.contributor.author Steyler, J.
dc.contributor.author Windle, K.
dc.contributor.author Borremans, M.
dc.contributor.author Resseler, S.
dc.contributor.author Van Roey, J.
dc.contributor.author Parys, W.
dc.contributor.author Vangeneugden, T.
dc.contributor.author Van Baelen, B.
dc.contributor.author Rosenberg, Z.
dc.date.accessioned 2017-01-23T08:39:13Z
dc.date.issued 2016-12-01
dc.description.abstract BACKGROUND The incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda. METHODS In this randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned participants in a 2:1 ratio to receive vaginal rings containing either 25 mg of dapivirine or placebo. Participants inserted the rings themselves every 4 weeks for up to 24 months. The primary efficacy end point was the rate of HIV type 1 (HIV-1) seroconversion. RESULTS A total of 77 participants in the dapivirine group underwent HIV-1 seroconversion during 1888 person-years of follow-up (4.1 seroconversions per 100 person-years), as compared with 56 in the placebo group who underwent HIV-1 seroconversion during 917 person-years of follow-up (6.1 seroconversions per 100 person-years). The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group (hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P = 0.04). There was no significant difference in efficacy of the dapivirine ring among women older than 21 years of age (hazard ratio for infection, 0.63; 95% CI, 0.41 to 0.97) and those 21 years of age or younger (hazard ratio, 0.85; 95% CI, 0.45 to 1.60; P = 0.43 for treatment-by-age interaction). Among participants with HIV-1 infection, nonnucleoside reverse-transcriptase inhibitor resistance mutations were detected in 14 of 77 participants in the dapivirine group (18.2%) and in 9 of 56 (16.1%) in the placebo group. Serious adverse events occurred more often in the dapivirine group (in 38 participants [2.9%]) than in the placebo group (in 6 [0.9%]). However, no clear pattern was identified. CONCLUSIONS Among women in sub-Saharan Africa, the dapivirine ring was not associated with any safety concerns and was associated with a rate of acquisition of HIV-1 infection that was lower than the rate with placebo. en_ZA
dc.description.department Family Medicine en_ZA
dc.description.embargo 2017-06-01
dc.description.librarian am2017 en_ZA
dc.description.sponsorship Supported by the International Partnership for Microbicides (a not-for-profit product-development partnership), which receives support from the Bill and Melinda Gates Foundation, Irish Aid, the Ministry of Foreign Affairs of Denmark, the Ministry of Foreign Affairs of the Netherlands, the Norwegian Agency for Development Cooperation, the U.K. Department for International Development, the American people through the U.S. Agency for International Development, and the President’s Emergency Plan for AIDS Relief. en_ZA
dc.description.uri http://www.nejm.org en_ZA
dc.identifier.citation Nel, A, Van Niekerk, S, Kapiga, S, Bekker, L-G, Gama, C, Gill, K, Kamali, A, Kotze, P, Louw, C, Mabude, Z, Miti, N, Kusemererwa, S, Tempelman, H, Carstens, H, Devlin, B, Isaacs, M, Malherbe, M, Mans, W, Nuttall, J, Russell, M, Ntshele, S, Smit, M, Solai, L, Spence, P. Steytler, J, Windle, K, Borremans, M, Resseler, S. Van Roey, J. Parys, W. Vangeneugden, T, Van Baelen, B & Rosenberg, Z 2016, ‘Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women', New England Journal of Medicine, vol. 375, no. 22, pp. 2133-2143. en_ZA
dc.identifier.issn 0028-4793 (print)
dc.identifier.issn 1533-4406 (online)
dc.identifier.other 10.1056/NEJMoa1602046 untranslated
dc.identifier.uri http://hdl.handle.net/2263/58598
dc.language.iso en en_ZA
dc.publisher Massachusetts Medical Society en_ZA
dc.rights © 2016 Massachusetts Medical Society en_ZA
dc.subject Women en_ZA
dc.subject Dapivirine ring en_ZA
dc.subject Treatment en_ZA
dc.subject HIV-1 infection en_ZA
dc.subject Human immunodeficiency virus (HIV) en_ZA
dc.subject Vaginal ring en_ZA
dc.title Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women en_ZA
dc.type Article en_ZA


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