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Prevention of HIV-1 infection with early antiretroviral therapy.
Open accessAbstract
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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“Therefore, ART not only is beneficial to the health of persons with HIV infection, it also reduces the risk for transmission.”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [94]
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“In 2011, the randomized controlled trial HPTN 052 demonstrated that, among HIV mixed-status heterosexual couples, HIV antiretroviral therapy (ART) for the infected partner decreased the risk for transmission to the uninfected partner by 96% (94).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [94]
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“As viral non-suppression increases the likelihood of rapid disease progression and onward transmission to sexual partners [4, 5]”
From Associations Between Patterns of Alcohol Use and Viral Load Suppression Amongst Women Living with HIV in South Africa (2021) · cites this paper as [5]
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Metadata
- 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
- 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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