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Prevention of HIV-1 infection with early antiretroviral therapy.

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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.·2011·New England Journal of Medicine

DOI 10.1056/nejmoa1105243PMC PMC3200068

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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 early-therapy 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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Authors: Cohen, M. S., Chen, Y. Q., McCauley, M., Gamble, T., Hosseinipour, M. C., Kumarasamy, N., Hakim, J. G., Kumwenda, J., Grinsztejn, B., Pilotto, J. H. S., Godbole, S. V., Mehendale, S., Chariyalertsak, S., Santos, B. R., Mayer, K. H., Hoffman, I. F., Eshleman, S. H., Piwowar-Manning, E., Wang, L., Makhema, J., Mills, L. A., de Bruyn, G., Sanne, I., Eron, J., Gallant, J., Havlir, D., Swindells, S., Ribaudo, H., Elharrar, V., Burns, D., Taha, T. E., Nielsen-Saines, K., Celentano, D., Essex, M., & Fleming, T. R.
Affiliations: University of North Carolina at Chapel Hill (US)
Fred Hutch Cancer Center (US)
YR Gaitonde Centre for AIDS Research and Education (IN)
University of Zimbabwe (ZW)
Johns Hopkins University (US)
National AIDS Research Institute (IN)
Chiang Mai University (TH)
Fenway Health (US)
Harvard University (US)
Kenya Medical Research Institute (KE)
University of California, San Francisco (US)
University of Nebraska Medical Center (US)
National Institutes of Health (US)
University of Washington (US)
ORCID: Cohen, Myron S.
Chen, Ying Q.
Gamble, Theresa
Hosseinipour, Mina C.
Kumarasamy, Nagalingeswaran
Hakim, James G.
Kumwenda, Johnstone
Grinsztejn, Beatriz
Godbole, Sheela V.
Mehendale, Sanjay
Chariyalertsak, Suwat
Santos, Breno R.
Mayer, Kenneth H.
Hoffman, Irving F.
Eshleman, Susan H.
Wang, Lei
Makhema, Joseph
Mills, Lisa A.
Sanne, Ian
Eron, Joseph
Gallant, Joel
Havlir, Diane
Swindells, Susan
Ribaudo, Heather
Burns, David
Taha, Taha E.
Celentano, David
Essex, Max
Fleming, Thomas R.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2011-08-11
Volume: 365
Issue: 6
Pages: 493-505
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1105243
PMC: PMC3200068
OpenAlex: W2152505869
Cited by: 6,873
References: 35
Citations by year: 2026: 106 · 2025: 155 · 2024: 189 · 2023: 204 · 2022: 288 · 2021: 354 · 2020: 398 · 2019: 471 · 2018: 510 · 2017: 594 · 2016: 694 · 2015: 720 · 2014: 759 · 2013: 740 · 2012: 571
FWCI: 466.60
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
Arca - Repositório Institucional da Fiocruz (submittedVersion, other-oa)
Funders: Abbott Laboratories
Bristol-Myers Squibb
Pfizer
GlaxoSmithKline
Sanofi
Gilead Sciences
ViiV Healthcare
Abbott Diagnostics
Sanofi Pasteur
National Institute of Allergy and Infectious Diseases (U01AI068617, U01AI068619, U01AI068613, K24AI051982, UM1AI068619, UM1AI069418, P30AI050410, UM1AI068613, UM1AI068617, P30AI027763)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R24HD042854)
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Keywords: HIV-1 prevention, early antiretroviral therapy, serodiscordant couples, sexual transmission of HIV, CD4 count, HIV-negative partners, tuberculosis, bacterial infection, AIDS mortality, HPTN 052
MeSH terms: Adolescent, Adult, Drug Therapy, Combination, Female, HIV Seropositivity, Humans, Male, Sexual Partners, HIV-1, HIV Infections, Proportional Hazards Models, Treatment Outcome, Disease Progression, Spouses, Disease Transmission, Infectious, Anti-Retroviral Agents, Kaplan-Meier Estimate, Young Adult

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