Daily Oral Tenofovir and Emtricitabine–Tenofovir Preexposure Prophylaxis Reduces Herpes Simplex Virus Type 2 Acquisition Among Heterosexual HIV-1–Uninfected Men and Women: A Subgroup Analysis of a Randomized Trial
Abstract
BACKGROUND: Daily oral preexposure prophylaxis (PrEP) using the antiretroviral tenofovir disoproxil fumarate (TDF) alone or in combination with emtricitabine (FTC-TDF) reduces the risk for HIV-1 acquisition. Tenofovir has in vitro activity against herpes simplex virus type 2 (HSV-2). OBJECTIVE: To assess the efficacy of daily oral PrEP with tenofovir and FTC-TDF in the prevention of HSV-2 acquisition. DESIGN: Subgroup analysis of data from a randomized, placebo-controlled trial with concealed allocation. (ClinicalTrials.gov: NCT00557245). SETTING: Multiple sites in Kenya and Uganda. PARTICIPANTS: Heterosexual men and women who were seronegative for HIV-1 and HSV-2 and at high risk for HIV-1 acquisition due to having an HIV-1-infected partner. INTERVENTION: Once-daily oral tenofovir disoproxil fumarate (TDF), alone or combined with emtricitabine (FTC-TDF), compared with placebo. MEASUREMENTS: HSV-2 seroconversion. RESULTS: A total of 131 participants seroconverted to HSV-2 (79 of 1041 assigned to tenofovir or FTC-TDF PrEP [HSV-2 incidence, 5.6 per 100 person-years] and 52 of 481 assigned to placebo [HSV-2 incidence, 7.7 per 100 person-years]). The hazard ratio (HR) for HSV-2 acquisition with daily oral PrEP was 0.70 (95% CI, 0.49 to 0.99; P = 0.047) compared with placebo, and the absolute risk reduction was 2.1 per 100 person-years. Among the 1044 participants with HSV-2-infected partners, the HR for PrEP was 0.67 (CI, 0.46 to 0.98; P = 0.038) compared with placebo, and the absolute risk reduction was 3.1 per 100 person-years. LIMITATION: Randomization was not stratified by HSV-2 status, and diagnostic tests to exclude participants with acute HSV-2 at baseline are not available. CONCLUSION: Daily oral tenofovir-based PrEP significantly reduced the risk for HSV-2 acquisition among heterosexual men and women. Modest protection against HSV-2 is an added benefit of HIV-1 prevention with oral tenofovir-based PrEP. PRIMARY FUNDING SOURCE: Bill & Melinda Gates Foundation.
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PrEP with daily oral TDF/FTC decreases the risk for HSV-2 acquisition by 30% in heterosexual partnerships.
“Randomized clinical trials have demonstrated that PrEP with daily oral TDF/FTC decreases the risk for HSV-2 acquisition by 30% in heterosexual partnerships (492).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [492]
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References 38 · Cited by 61
- Authors
- Celum, C., Morrow, R. A., Donnell, D., Hong, T., Hendrix, C. W., Thomas, K. K., Fife, K. H., Nakku-Joloba, E., Mujugira, A., Baeten, J. M., & for the Partners PrEP Study Team*
- Affiliations
- Johns Hopkins University (US)
- From University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington; Johns Hopkins University, Baltimore, Maryland; Indiana University, Indianapolis, Indiana; and Makerere University, Kampala, Uganda.
- ORCID
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2014-07-01
- Volume
- 161
- Issue
- 1
- Pages
- 11-19
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W1964489937
- Cited by
- 61
- References
- 38
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3 · 2023: 5 · 2022: 3 · 2021: 6 · 2020: 1 · 2019: 7 · 2018: 6 · 2017: 5 · 2016: 5 · 2015: 14 · 2014: 2
- FWCI
- 6.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Herpesvirus Infections and Treatments
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Keywords
- herpes simplex virus type 2, pre-exposure prophylaxis, tenofovir disoproxil fumarate, tenofovir/emtricitabine, oral antiretroviral therapy, HIV-1 prevention
- MeSH terms
- Emtricitabine, Tenofovir, Adenine, Administration, Oral, Adult, Antiviral Agents, Deoxycytidine, Drug Therapy, Combination, Female, Herpes Genitalis, Humans, Male, RNA, Viral, HIV-1, HIV Infections, Incidence, HIV Seronegativity, Herpesvirus 2, Human, Heterosexuality, Anti-Retroviral Agents, Medication Adherence, Organophosphonates
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