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2030-01-01
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PREVENTION OF HIV-1 INFECTION WITH EARLY ANTIRETROVIRAL THERAPY
Author
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.
Mehendale, Sanjay
Chariyalertsak, Suwat
Santos, Breno R.
Mayer, Kenneth H.
Hoffman, Irving F.
Eshleman, Susan H.
Piwowar-Manning, Estelle
Wang, Lei
Makhema, Joseph
Mills, Lisa A.
de Bruyn, Guy
Sanne, Ian
Eron, Joseph
Gallant, Joel
Havlir, Diane
Swindells, Susan
Ribaudo, Heather
Elharrar, Vanessa
Burns, David
Taha, Taha E.
Nielsen-Saines, Karin
Celentano, David
Essex, Max
Fleming, Thomas R.
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.
Mehendale, Sanjay
Chariyalertsak, Suwat
Santos, Breno R.
Mayer, Kenneth H.
Hoffman, Irving F.
Eshleman, Susan H.
Piwowar-Manning, Estelle
Wang, Lei
Makhema, Joseph
Mills, Lisa A.
de Bruyn, Guy
Sanne, Ian
Eron, Joseph
Gallant, Joel
Havlir, Diane
Swindells, Susan
Ribaudo, Heather
Elharrar, Vanessa
Burns, David
Taha, Taha E.
Nielsen-Saines, Karin
Celentano, David
Essex, Max
Fleming, Thomas R.
Affilliation
University of North Carolina. School of Medicine. South Carolina, USA.
Fred Hutchinson Cancer Research Center. Seattle, Washington, USA.
Family Health International. Arlington, VA, USA.
Family Health International. Durham, NC, USA.
University of North Carolina. School of Medicine. South Carolina, USA.
Gaitonade Center for AIDS Research and Education. Chennai, India.
University of Zimbabwe, Harare, Zimbabwe.
College of Medicine.Johns Hopkins Project, Blantyre, India.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clinica Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ. Brasil.
National AIDS Research Institute. Pune, India.
National AIDS Research Institute. Pune, India.
Chiang Mai University. Research Institute for Health Sciences.Chiang Mai, Thailand.
Hospital Nossa Senhora da Conceição. Porto Alegre, RS, Brasil.
Fenway Health. Boston, USA.
University of North Carolina. School of Medicine. South Carolina, USA.
Johns Hopkins University School of Medicine. Baltimore. USA.
Johns Hopkins University School of Medicine. Baltimore. USA.
Fred Hutchinson Cancer Research Center. Seattle, USA.
Botswana Harvard AIDS Institute. Gaborone. Botswana.
Kenya Medical Research Institute. CDC Research and Public Health Collaboration HIV Research Branch. Kisumu, Kenia.
Perinatal HIV Research Unit. Johannesburg, South Africa.
University of the Witwatersrand. Department of Medicine. Johannesburg, South Africa.
University of North Carolina School of Medicine. Chapel Hill, Seattle, USA.
Johns Hopkins University School of Medicine. Baltimore, USA.
University of California. San Francisco, CA, USA.
University of Nebraska Medical Center. Omaha, Nebraska, USA.
Harvard School of Public Health. Boston, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.
Johns Hopkins Bloomberg School of Public Health.Baltimore, USA.
David Geffen UCLA School of Medicine. Los Angeles, CA, USA.
Johns Hopkins Bloomberg School of Public Health.Baltimore, USA.
Harvard School of Public Health. Boston, USA.
University of Washington. Washington, USA.
Fred Hutchinson Cancer Research Center. Seattle, Washington, USA.
Family Health International. Arlington, VA, USA.
Family Health International. Durham, NC, USA.
University of North Carolina. School of Medicine. South Carolina, USA.
Gaitonade Center for AIDS Research and Education. Chennai, India.
University of Zimbabwe, Harare, Zimbabwe.
College of Medicine.Johns Hopkins Project, Blantyre, India.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clinica Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ. Brasil.
National AIDS Research Institute. Pune, India.
National AIDS Research Institute. Pune, India.
Chiang Mai University. Research Institute for Health Sciences.Chiang Mai, Thailand.
Hospital Nossa Senhora da Conceição. Porto Alegre, RS, Brasil.
Fenway Health. Boston, USA.
University of North Carolina. School of Medicine. South Carolina, USA.
Johns Hopkins University School of Medicine. Baltimore. USA.
Johns Hopkins University School of Medicine. Baltimore. USA.
Fred Hutchinson Cancer Research Center. Seattle, USA.
Botswana Harvard AIDS Institute. Gaborone. Botswana.
Kenya Medical Research Institute. CDC Research and Public Health Collaboration HIV Research Branch. Kisumu, Kenia.
Perinatal HIV Research Unit. Johannesburg, South Africa.
University of the Witwatersrand. Department of Medicine. Johannesburg, South Africa.
University of North Carolina School of Medicine. Chapel Hill, Seattle, USA.
Johns Hopkins University School of Medicine. Baltimore, USA.
University of California. San Francisco, CA, USA.
University of Nebraska Medical Center. Omaha, Nebraska, USA.
Harvard School of Public Health. Boston, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Bethesda, MD, USA.
Johns Hopkins Bloomberg School of Public Health.Baltimore, USA.
David Geffen UCLA School of Medicine. Los Angeles, CA, USA.
Johns Hopkins Bloomberg School of Public Health.Baltimore, USA.
Harvard School of Public Health. Boston, USA.
University of Washington. Washington, USA.
Abstract
Background
Antiretroviral therapy that reduces viral replication could limit the transmission of
human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.
Methods
In nine countries, we enrolled 1763 couples in which one partner was HIV-1–positive
and the other was HIV-1–negative; 54% of the subjects were from Africa, and 50%
of infected partners were men. HIV-1–infected subjects with CD4 counts between
350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive
antiretroviral therapy either immediately (early therapy) or after a decline in the CD4
count or the onset of HIV-1–related symptoms (delayed therapy). The primary prevention
end point was linked HIV-1 transmission in HIV-1–negative partners. The primary
clinical end point was the earliest occurrence of pulmonary tuberculosis, severe
bacterial infection, a World Health Organization stage 4 event, or death.
Results
As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence
rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were
virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years,
95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the earlytherapy
group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving
early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to
0.88; P = 0.01).
Conclusions
The early initiation of antiretroviral therapy reduced rates of sexual transmission of
HIV-1 and clinical events, indicating both personal and public health benefits from
such therapy. (Funded by the National Institute of Allergy and Infectious Diseases
and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.)
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