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Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women.
Baeten, Jared M; Palanee-Phillips, Thesla; Brown, Elizabeth R; Schwartz, Katie; Soto-Torres, Lydia E; Govender, Vaneshree; Mgodi, Nyaradzo M; Matovu Kiweewa, Flavia; Nair, Gonasagrie; Mhlanga, Felix; Siva, Samantha; Bekker, Linda-Gail; Jeenarain, Nitesha; Gaffoor, Zakir; Martinson, Francis; Makanani, Bonus; Pather, Arendevi; Naidoo, Logashvari; Husnik, Marla; Richardson, Barbra A; Parikh, Urvi M; Mellors, John W; Marzinke, Mark A; Hendrix, Craig W; van der Straten, Ariane; Ramjee, Gita; Chirenje, Zvavahera M; Nakabiito, Clemensia; Taha, Taha E; Jones, Judith; Mayo, Ashley; Scheckter, Rachel; Berthiaume, Jennifer; Livant, Edward; Jacobson, Cindy; Ndase, Patrick; White, Rhonda; Patterson, Karen; Germuga, Donna; Galaska, Beth; Bunge, Katherine; Singh, Devika; Szydlo, Daniel W; Montgomery, Elizabeth T; Mensch, Barbara S; Torjesen, Kristine; Grossman, Cynthia I; Chakhtoura, Nahida; Nel, Annalene; Rosenberg, Zeda.
Afiliación
  • Baeten JM; 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
  • Palanee-Phillips T; 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
  • Brown ER; 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
  • Schwartz K; 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
  • Soto-Torres LE; 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
  • Govender V; 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
  • Mgodi NM; 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
  • Matovu Kiweewa F; 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
  • Nair G; 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
  • Mhlanga F; 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
  • Siva S; 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
  • Bekker LG; 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
  • Jeenarain N; 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
  • Gaffoor Z; 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
  • Martinson F; 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
  • Makanani B; 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
  • Pather A; 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
  • Naidoo L; 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
  • Husnik M; 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
  • Richardson BA; 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
  • Parikh UM; 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
  • Mellors JW; 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
  • Marzinke MA; 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
  • Hendrix CW; 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
  • van der Straten A; 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
  • Ramjee G; 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
  • Chirenje ZM; 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
  • Nakabiito C; 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
  • Taha TE; 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
  • Jones J; 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
  • Mayo A; 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
  • Scheckter R; 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
  • Berthiaume J; 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
  • Livant E; 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
  • Jacobson C; 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
  • Ndase P; 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
  • White R; 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
  • Patterson K; 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
  • Germuga D; 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
  • Galaska B; 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
  • Bunge K; 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
  • Singh D; 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
  • Szydlo DW; 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
  • Montgomery ET; 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
  • Mensch BS; 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
  • Torjesen K; 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
  • Grossman CI; 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
  • Chakhtoura N; 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
  • Nel A; 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
  • Rosenberg Z; 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
N Engl J Med ; 375(22): 2121-2132, 2016 12 01.
Article en En | MEDLINE | ID: mdl-26900902
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 .).
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pirimidinas / Infecciones por VIH / VIH-1 / Inhibidores de la Transcriptasa Inversa Tipo de estudio: Clinical_trials / Incidence_studies / Prognostic_studies Límite: Adolescent / Adult / Female / Humans / Middle aged País/Región como asunto: Africa Idioma: En Revista: N Engl J Med Año: 2016 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pirimidinas / Infecciones por VIH / VIH-1 / Inhibidores de la Transcriptasa Inversa Tipo de estudio: Clinical_trials / Incidence_studies / Prognostic_studies Límite: Adolescent / Adult / Female / Humans / Middle aged País/Región como asunto: Africa Idioma: En Revista: N Engl J Med Año: 2016 Tipo del documento: Article