Antiretroviral therapy for the prevention of HIV-1 transmission.
Open accessAbstract
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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Effective ART that suppresses HIV replication to undetectable levels reduces morbidity, provides a near-normal lifespan, and prevents sexual transmission of HIV to others.
“Effective ART that suppresses HIV replication to undetectable levels reduces morbidity, provides a near-normal lifespan, and prevents sexual transmission of HIV to others (95–97,410–412).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [412]
The Abstract Results report a 93% lower risk of genetically linked partner infection with early ART and no linked infections when HIV-1 was stably suppressed. The Discussion also reports health benefits from early ART, but the paper does not establish that ART provides a near-normal lifespan. (LLM, conf=0.88)
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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., Chariyalertsak, S., Santos, B. R., Mayer, K. H., Hoffman, I. F., Eshleman, S. H., Piwowar-Manning, E., Cottle, L., Zhang, X. C., Makhema, J., Mills, L. A., Panchia, R., Faesen, S., Eron, J., Gallant, J., Havlir, D., Swindells, S., Elharrar, V., Burns, D., Taha, T. E., Nielsen-Saines, K., Celentano, D. D., Essex, M., Hudelson, S. E., Redd, A. D., & Fleming, T. R.
- Affiliations
- University of North Carolina at Chapel Hill (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.
- Chariyalertsak, Suwat
- Santos, Breno R.
- Mayer, Kenneth H.
- Hoffman, Irving F.
- Eshleman, Susan H.
- Makhema, Joseph
- Mills, Lisa A.
- Panchia, Ravindre
- Eron, Joseph
- Gallant, Joel
- Havlir, Diane
- Swindells, Susan
- Burns, David
- Taha, Taha E.
- Celentano, David D.
- Essex, Max
- Redd, Andrew D.
- Fleming, Thomas R.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-09
- Volume
- 375
- Issue
- 9
- Pages
- 830-839
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5049503
- OpenAlex
- W2475857717
- Cited by
- 1,700
- References
- 25
- Citations by year
- 2026: 103 · 2025: 147 · 2024: 135 · 2023: 177 · 2022: 176 · 2021: 211 · 2020: 211 · 2019: 203 · 2018: 183 · 2017: 127 · 2016: 24 · 2015: 2
- FWCI
- 165.16
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- DigitalCommons@UNMC (submittedVersion)
- Arca - Repositório Institucional da Fiocruz (submittedVersion, other-oa)
- eScholarship (California Digital Library) (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
- Funders
- National Institute of Allergy and Infectious Diseases (U01AI068617, U01AI068636, U01AI068619, U01AI068613, UM1AI069432, UM1AI068619, UM1AI069456, UM1AI069518, UM1AI068634, P30AI050410, UM1AI068613, UM1AI069423, UM1AI068617, UM1AI069496, UM1AI069399, UM1AI069424, UM1AI069463)
- 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 transmission prevention, antiretroviral therapy, serodiscordant couples, HIV-1, HPTN 052, CD4 count, viral suppression, HIV prevention, treatment durability, AIDS-defining illness
- MeSH terms
- Adult, Female, Follow-Up Studies, HIV Seropositivity, Humans, Male, Middle Aged, Risk, Sexual Partners, HIV-1, HIV Infections, Disease Transmission, Infectious, Anti-Retroviral Agents, Kaplan-Meier Estimate, Young Adult, Intention to Treat Analysis
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