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Poverty and InequalitySexual and Reproductive HealthFamily, Maternal & Child HealthMethodology

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

TitleUse of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women
Publication TypeJournal Article
Year of Publication2016
AuthorsBaeten, JM, Palanee-Phillips, T, Brown, ER, Schwartz, K, Soto-Torres, LE, Govender, V, Mgodi, NM, Matovu Kiweewa, F, Nair, G, Mhlanga, F, Siva, S, Bekker, LG, Jeenarain, N, Gaffoor, Z, Martinson, F, Makanani, B, Pather, A, Naidoo, L, Husnik, M, Richardson, BA, Parikh, UM, Mellors, JW, Marzinke, MA, Hendrix, CW, van der Straten, A, Ramjee, G, Chirenje, ZM, Nakabiito, C, Taha, TE, Jones, J, Mayo, A, Scheckter, R, Berthiaume, J, Livant, E, Jacobson, C, Ndase, P, White, R, Patterson, K, Germuga, D, Galaska, B, Bunge, K, Singh, D, Szydlo, DW, Montgomery, ET, Mensch, BS, Torjesen, K, Grossman, CI, Chakhtoura, N, Nel, A, Rosenberg, Z, McGowan, I, Hillier, S, Team, M-AS
JournalN Engl J Med
Volume375
Pagination2121-2132
Date PublishedFeb 22
ISBN Number1533-4406 (Electronic)0028-4793 (Linking)
Accession Number26900902
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=0.05) 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 .).