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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ART not only is beneficial to the health of persons with HIV infection, it also reduces the risk for transmission.
“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]
HPTN 052 demonstrated that among HIV mixed-status heterosexual couples, ART for the infected partner decreased the risk for transmission to the uninfected partner by 96%.
“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]
Viral non-suppression increases the likelihood of rapid disease progression and onward transmission to sexual partners.
“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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- 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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