Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.
Open accessAbstract
BACKGROUND: Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations. METHODS: We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services. RESULTS: We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study. CONCLUSIONS: Oral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.).
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One clinical trial involving persons who inject drugs and one involving heterosexual mixed-status couples demonstrated substantial efficacy and safety of daily oral PrEP with TDF alone.
“In addition, one clinical trial involving persons who inject drugs (78) and one involving heterosexual mixed-status couples (76) demonstrated substantial efficacy and safety of daily oral PrEP with TDF alone.”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [76]
TDF/FTC has demonstrated safety and efficacy for mixed-status heterosexual couples and heterosexual men and women recruited individually.
“TDF/FTC has demonstrated safety and efficacy for mixed-status heterosexual couples (76) and heterosexual men and women recruited individually (77); however, no evidence is yet available regarding TAF/FTC among heterosexually active women.”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [76]
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References 37 · Cited by 3,256
Research works printed but not linked: 4
- [20]Thigpen MC Kebaabetswe PM Smith DK Daily oral antiretroviral use for the prevention of HIV infection in heterosexually active young adults in Botswana: results from the TDF2 study 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention Rome, Italy 17–20 July 2011 Abstract WELBC01
- [26]Haberer J Baeten J Celum C Near perfect early adherence to antiretroviral PrEP against HIV infection among HIV serodiscordant couples as determined by multiple measures: preliminary data from the Partners PrEP Study 18th Conference on Retroviruses and Opportunistic Infections Boston, USA 27 February – 2 March 2011 Abstract 488
- [27]Ware NC Wyatt MA Haberer J Baeten J Celum C Bangsberg DR “What’s Love Got to Do With It?” A relationship framework for research on adherence to antiretroviral therapy (ART) as pre-exposure prophylaxis 6th International Conference on HIV Treatment and Prevention Adherence Miami, USA 22–24 May 2011 Abstract 70018
- [34]Hallett T Baeten J Heffron R ART or PrEP for HIV prevention in HIV serodiscordant partnerships: a mathematical modeling comparison 18th Conference on Retroviruses and Opportunistic Infections Boston, USA 27 February – 2 March 2011 Abstract 134
- Authors
- Baeten, J. M., Donnell, D., Ndase, P., Mugo, N. R., Campbell, J. D., Wangisi, J., Tappero, J. W., Bukusi, E. A., Cohen, C. R., Katabira, E., Ronald, A., Tumwesigye, E., Were, E., Fife, K. H., Kiarie, J., Farquhar, C., John-Stewart, G., Kakia, A., Odoyo, J., Mucunguzi, A., Nakku-Joloba, E., Twesigye, R., Ngure, K., Apaka, C., Tamooh, H., Gabona, F., Mujugira, A., Panteleeff, D., Thomas, K. K., Kidoguchi, L., Krows, M., Revall, J., Morrison, S., Haugen, H., Emmanuel-Ogier, M., Ondrejcek, L., Coombs, R. W., Frenkel, L., Hendrix, C., Bumpus, N. N., Bangsberg, D., Haberer, J. E., Stevens, W. S., Lingappa, J. R., & Celum, C.
- Affiliations
- University of Washington (US)
- University of Nairobi (KE)
- Centers for Disease Control and Prevention (US)
- The AIDS Support Organization (UG)
- University of California, San Francisco (US)
- Infectious Diseases Institute (UG)
- Moi University (KE)
- Indiana University Indianapolis (US)
- Kenya Medical Research Institute (KE)
- Seattle Children's Hospital (US)
- Johns Hopkins University (US)
- Harvard University (US)
- ORCID
- Baeten, Jared M.
- Donnell, Deborah
- Mugo, Nelly R.
- Campbell, James D.
- Tappero, Jordan W.
- Bukusi, Elizabeth A.
- Cohen, Craig R.
- Katabira, Elly
- Ronald, Allan
- Were, Edwin
- Kiarie, James
- Farquhar, Carey
- John-Stewart, Grace
- Kakia, Aloysious
- Odoyo, Josephine
- Mucunguzi, Akasiima
- Ngure, Kenneth
- Tamooh, Harrison
- Mujugira, Andrew
- Thomas, Katherine K.
- Krows, Meighan
- Morrison, Susan
- Haugen, Harald
- Coombs, Robert W.
- Frenkel, Lisa
- Hendrix, Craig
- Bumpus, Namandjé N.
- Bangsberg, David
- Haberer, Jessica E.
- Stevens, Wendy S.
- Lingappa, Jairam R.
- Celum, Connie
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-08-02
- Volume
- 367
- Issue
- 5
- Pages
- 399-410
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3770474
- OpenAlex
- W2117057469
- Cited by
- 3,256
- References
- 37
- Citations by year
- 2026: 100 · 2025: 172 · 2024: 168 · 2023: 182 · 2022: 212 · 2021: 253 · 2020: 246 · 2019: 264 · 2018: 239 · 2017: 263 · 2016: 307 · 2015: 252 · 2014: 275 · 2013: 222 · 2012: 92
- FWCI
- 186.57
- 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)
- eScholarship (California Digital Library) (submittedVersion)
- University of Nairobi Research Archive (University of Nairobi) (submittedVersion)
- Funders
- Bill and Melinda Gates Foundation (47674)
- Gilead Sciences
- Centers for Disease Control and Prevention
- National Institute of Mental Health (K23MH087228)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Keywords
- HIV-1 prevention, tenofovir, emtricitabine, tenofovir/emtricitabine, heterosexual transmission, HIV-1 incidence, antiretroviral prophylaxis, women's health, adverse events, Kenya, Uganda, sub-Saharan Africa
- MeSH terms
- Emtricitabine, Tenofovir, Adenine, Adolescent, Adult, Contraception Behavior, Deoxycytidine, Double-Blind Method, Drug Combinations, Female, HIV Seropositivity, Humans, Male, Middle Aged, Pregnancy, RNA, Viral, Sexual Behavior, HIV-1, HIV Infections, Incidence, Heterosexuality, Drug Resistance, Viral, Anti-Retroviral Agents, Young Adult, Organophosphonates
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