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Antiretroviral Therapy for the Prevention of HIV-1 Transmission.
Cohen, Myron S; Chen, Ying Q; McCauley, Marybeth; Gamble, Theresa; Hosseinipour, Mina C; Kumarasamy, Nagalingeswaran; Hakim, James G; Kumwenda, Johnstone; Grinsztejn, Beatriz; Pilotto, Jose H S; Godbole, Sheela V; Chariyalertsak, Suwat; Santos, Breno R; Mayer, Kenneth H; Hoffman, Irving F; Eshleman, Susan H; Piwowar-Manning, Estelle; Cottle, Leslie; Zhang, Xinyi C; Makhema, Joseph; Mills, Lisa A; Panchia, Ravindre; Faesen, Sharlaa; Eron, Joseph; Gallant, Joel; Havlir, Diane; Swindells, Susan; Elharrar, Vanessa; Burns, David; Taha, Taha E; Nielsen-Saines, Karin; Celentano, David D; Essex, Max; Hudelson, Sarah E; Redd, Andrew D; Fleming, Thomas R.
Afiliação
  • Cohen MS; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Chen YQ; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • McCauley M; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Gamble T; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Hosseinipour MC; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Kumarasamy N; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Hakim JG; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Kumwenda J; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Grinsztejn B; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Pilotto JH; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Godbole SV; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Chariyalertsak S; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Santos BR; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Mayer KH; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Hoffman IF; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Eshleman SH; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Piwowar-Manning E; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Cottle L; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Zhang XC; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Makhema J; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Mills LA; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Panchia R; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Faesen S; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Eron J; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Gallant J; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Havlir D; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Swindells S; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Elharrar V; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Burns D; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Taha TE; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Nielsen-Saines K; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Celentano DD; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Essex M; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Hudelson SE; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Redd AD; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
  • Fleming TR; From the Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (M.S.C., M.C.H., I.F.H., J.E.); the Divisions of Vaccine and Infectious Disease (Y.Q.C., X.C.Z.) and Public Health Science (Y.Q.C.) and the Statistical Center for HIV/AIDS Research and Prevention (L.C.), Fred H
N Engl J Med ; 375(9): 830-9, 2016 09 01.
Article em En | MEDLINE | ID: mdl-27424812
ABSTRACT

BACKGROUND:

An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.

METHODS:

We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis.

RESULTS:

Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant.

CONCLUSIONS:

The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581 .).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Parceiros Sexuais / Infecções por HIV / HIV-1 / Transmissão de Doença Infecciosa / Antirretrovirais Tipo de estudo: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2016 Tipo de documento: Article
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Parceiros Sexuais / Infecções por HIV / HIV-1 / Transmissão de Doença Infecciosa / Antirretrovirais Tipo de estudo: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2016 Tipo de documento: Article