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From the Departments of Global Health (J.M.B., B.A.R., P.N.), Medicine (J.M.B.), Epidemiology (J.M.B., M.H.), and Biostatistics (E.R.B., B.A.R.), University of Washington, and the Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center (E.R.B., M.H., B.A.R., J.B., K.P., D.W.S.) - both in Seattle; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg (T.P.-P.), HIV Prevention Research Unit, South African Medical Research Council (V.G., S.S., N.J., Z.G., A.P., L.N., G.R.), and Center for AIDS Programme of Research in South Africa (G.N.), Durban, and the Desmond Tutu HIV Center, University of Cape Town, Cape Town (L.-G.B.) - all in South Africa; FHI 360, Durham, NC (K.S., A.M., R.S., R.W., K.T.); National Institute of Allergy and Infectious Diseases (L.E.S.-T., D.G.), National Institute of Mental Health (C.I.G.), and Eunice Kennedy Shiver National Institute of Child Health and Human Development (N.C.), National Institutes of Health, Bethesda, the Departments of Medicine (M.A.M., C.W.H.) and Epidemiology (T.E.T.), Johns Hopkins University, Baltimore, and the International Partnership for Microbicides, Silver Spring (A.N., Z.R.) - all in Maryland; University of Zimbabwe-University of California San Francisco Collaborative Research Program, Harare, Zimbabwe (N.M.M., F. Mhlanga, Z.M.C.); Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda (F.M.K., C.N.); University of North Carolina Project, Lilongwe (F. Martinson), and Malawi College of Medicine-Johns Hopkins University Research Project, Queen Elizabeth Central Hospital, Blantyre (B.M., T.E.T.) - both in Malawi; the Departments of Medicine (U.M.P., J.W.M., I.M.) and Obstetrics, Gynecology, and Reproductive Sciences (K.B., S.H.), University of Pittsburgh, and Magee-Women's Research Institute (J.J., E.L., C.J., B.G., D.S.) - both in Pittsburgh; the Women's Global Health Imperative, RTI International (A.S., E.T.M.), and the Department of Medicine, University of California (A.S.) - both in San Francisco; and the Population Council, New York (B.S.M.).
Published: December 2016
AI Article Synopsis
Article 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 .).
