Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana.
Open accessAbstract
BACKGROUND: Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain. METHODS: We randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants. RESULTS: A total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03). CONCLUSIONS: Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).
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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 [77]
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- Authors
- Thigpen, M. C., Kebaabetswe, P. M., Paxton, L. A., Smith, D. K., Rose, C. E., Segolodi, T. M., Henderson, F. L., Pathak, S. R., Soud, F. A., Chillag, K. L., Mutanhaurwa, R., Chirwa, L. I., Kasonde, M., Abebe, D., Buliva, E., Gvetadze, R. J., Johnson, S., Sukalac, T., Thomas, V. T., Hart, C., Johnson, J. A., Malotte, C. K., Hendrix, C. W., & Brooks, J. T.
- Affiliations
- Centers for Disease Control and Prevention (US)
- Northrop Grumman (United States) (US)
- California State University, Long Beach (US)
- Johns Hopkins University (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-08-02
- Volume
- 367
- Issue
- 5
- Pages
- 423-434
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2162226934
- Cited by
- 1,996
- References
- 12
- Citations by year
- 2026: 38 · 2025: 77 · 2024: 77 · 2023: 82 · 2022: 111 · 2021: 138 · 2020: 139 · 2019: 162 · 2018: 162 · 2017: 178 · 2016: 209 · 2015: 199 · 2014: 192 · 2013: 159 · 2012: 65
- FWCI
- 135.82
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Health and Human Services
- International AIDS Society
- National Institutes of Health
- Centers for Disease Control and Prevention
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Keywords
- HIV pre-exposure prophylaxis, tenofovir disoproxil fumarate, emtricitabine, heterosexual transmission, HIV prevention, antiretroviral drugs, bone mineral density, drug safety, antiretroviral resistance mutations, acute HIV infection, Botswana, prevention services, sexually transmitted infections, nausea and dizziness
- MeSH terms
- Emtricitabine, Tenofovir, Adenine, Adolescent, Adult, Contraception Behavior, Deoxycytidine, Drug Therapy, Combination, Female, HIV Seropositivity, Humans, Male, RNA, Viral, Sexual Behavior, HIV-1, HIV-2, Bone Density, HIV Infections, Proportional Hazards Models, Viral Load, Drug Resistance, Viral, Anti-Retroviral Agents, Kaplan-Meier Estimate, Young Adult, Organophosphonates
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