Tenofovir-based preexposure prophylaxis for HIV infection among African women.
Open accessAbstract
BACKGROUND: Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 (HIV-1) infection. METHODS: We conducted a randomized, placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate (TDF), oral tenofovir-emtricitabine (TDF-FTC), or 1% tenofovir (TFV) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. HIV-1 testing was performed monthly, and plasma TFV levels were assessed quarterly. RESULTS: Of 12,320 women who were screened, 5029 were enrolled in the study. The rate of retention in the study was 91% during 5509 person-years of follow-up. A total of 312 HIV-1 infections occurred; the incidence of HIV-1 infection was 5.7 per 100 person-years. In the modified intention-to-treat analysis, the effectiveness was -49.0% with TDF (hazard ratio for infection, 1.49; 95% confidence interval [CI], 0.97 to 2.29), -4.4% with TDF-FTC (hazard ratio, 1.04; 95% CI, 0.73 to 1.49), and 14.5% with TFV gel (hazard ratio, 0.85; 95% CI, 0.61 to 1.21). In a random sample, TFV was detected in 30%, 29%, and 25% of available plasma samples from participants randomly assigned to receive TDF, TDF-FTC, and TFV gel, respectively. Independent predictors of TFV detection included being married, being older than 25 years of age, and being multiparous. Detection of TFV in plasma was negatively associated with characteristics predictive of HIV-1 acquisition. Elevations of serum creatinine levels were seen more frequently among participants randomly assigned to receive oral TDF-FTC than among those assigned to receive oral placebo (1.3% vs. 0.2%, P=0.004). We observed no significant differences in the frequencies of other adverse events. CONCLUSIONS: None of the drug regimens we evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis. Adherence to study drugs was low. (Funded by the National Institutes of Health; VOICE ClinicalTrials.gov number, NCT00705679.).
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Adherence to tenofovir gel can be low.
“Adherence can be low (48), and prevention of HIV infection, especially among women, has not been demonstrated (47,49).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [48]
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- Authors
- Marrazzo, J. M., Ramjee, G., Richardson, B. A., Gomez, K., Mgodi, N., Nair, G., Palanee, T., Nakabiito, C., van der Straten, A., Noguchi, L., Hendrix, C. W., Dai, J. Y., Ganesh, S., Mkhize, B., Taljaard, M., Parikh, U. M., Piper, J., Mâsse, B., Grossman, C., Rooney, J., Schwartz, J. L., Watts, H., Marzinke, M. A., Hillier, S. L., McGowan, I. M., & Chirenje, Z. M.
- Affiliations
- University of California, San Francisco (US)
- Harborview Medical Center (US)
- Family Health International 360 (US)
- University of Zimbabwe (ZW)
- Centre for the AIDS Programme of Research in South Africa (ZA)
- University of Pittsburgh (US)
- Johns Hopkins University (US)
- South African Medical Research Council (ZA)
- National Institutes of Health (US)
- Eastern Virginia Medical School (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-02-05
- Volume
- 372
- Issue
- 6
- Pages
- 509-518
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4341965
- OpenAlex
- W2044369525
- Cited by
- 1,296
- References
- 19
- Citations by year
- 2026: 32 · 2025: 54 · 2024: 59 · 2023: 78 · 2022: 93 · 2021: 143 · 2020: 125 · 2019: 139 · 2018: 122 · 2017: 140 · 2016: 175 · 2015: 131 · 2014: 1
- FWCI
- 147.62
- 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)
- ResearchSpace (University of KwaZulu-Natal) (submittedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (U01AI068633, UM1AI068615, UM1AI069422, UM1AI106707, UM1AI069436, P30AI094189, UM1AI069530, UM1AI069463, UM1AI069469)
- 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
- tenofovir disoproxil fumarate, tenofovir/emtricitabine, HIV pre-exposure prophylaxis, HIV-1 prevention, women, women of reproductive age, antiretroviral resistance, tenofovir resistance, drug safety, adverse events, creatinine elevation
- MeSH terms
- Emtricitabine, Tenofovir, Adenine, Administration, Intravaginal, Administration, Oral, Adolescent, Adult, Deoxycytidine, Drug Therapy, Combination, Female, HIV Seropositivity, Humans, Middle Aged, Surveys and Questionnaires, HIV-1, HIV Infections, Africa South of the Sahara, Drug Resistance, Viral, Anti-Retroviral Agents, Medication Adherence, Young Adult, Organophosphonates, Pre-Exposure Prophylaxis
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