Tenofovir gel for the prevention of herpes simplex virus Type 2 infection.
Open accessAbstract
BACKGROUND: Globally, herpes simplex virus type 2 (HSV-2) infection is the most common cause of genital ulcer disease. Effective prevention strategies for HSV-2 infection are needed to achieve the goals of the World Health Organization global strategy for the prevention and control of sexually transmitted infections. METHODS: We assessed the effectiveness of pericoital tenofovir gel, an antiviral microbicide, in preventing HSV-2 acquisition in a subgroup of 422 HSV-2-negative women enrolled in the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 study, a double-blind, randomized, placebo-controlled trial. Incident HSV-2 cases were identified by evidence of seroconversion on an HSV-2 IgG enzyme-linked immunosorbent assay between study enrollment and exit. A confirmatory analysis was performed by Western blot testing. RESULTS: The HSV-2 incidence rate was 10.2 cases per 100 person-years (95% confidence interval [CI], 6.8 to 14.7) among 202 women assigned to tenofovir gel, as compared with 21.0 cases per 100 person-years (95% CI, 16.0 to 27.2) among 222 women assigned to placebo gel (incidence rate ratio, 0.49; 95% CI, 0.30 to 0.77; P=0.003). The HSV-2 incidence rate among the 25 women with vaginal tenofovir concentrations of 10,000 ng per milliliter or more was 5.7 cases per 100 person-years, as compared with 15.5 cases per 100 person-years among the 103 women with no detectable vaginal tenofovir (incidence rate ratio, 0.37; 95% CI, 0.04 to 1.51; P=0.14). As confirmed by Western blot testing, there were 16 HSV-2 seroconversions among women assigned to tenofovir gel as compared with 36 among those assigned to the placebo gel (incidence rate ratio, 0.45; 95% CI, 0.23 to 0.82; P=0.005). CONCLUSIONS: In this study in South Africa, pericoital application of tenofovir gel reduced HSV-2 acquisition in women. (Funded by the U.S. Agency for International Development and others; ClinicalTrials.gov number, NCT00441298.).
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Tenofovir gel has been studied for prevention of HSV-2 and HIV infections.
“Tenofovir gel has been studied for prevention of herpes simplex virus 2 (HSV-2) and HIV infections (46,47).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [46]
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Research works printed but not linked: 1
- [8]Rees H Delany-Moretlwe SA Lombard C FACTS 001 phase III trial of pericoital tenofovir 1% gel for HIV prevention in women Presented at the Conference on Retroviruses and Opportunistic Infections (CROI) February 23–26, 2015 Seattle abstract.
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Sexually Transmitted Infections Treatment Guidelines, 2021
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Vaginal bacteria modify HIV tenofovir microbicide efficacy in African women
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- Authors
- Abdool Karim, S. S., Abdool Karim, Q., Kharsany, A. B. M., Baxter, C., Grobler, A. C., Werner, L., Kashuba, A., Mansoor, L. E., Samsunder, N., Mindel, A., & Gengiah, T. N.
- Affiliations
- National Institutes of Health (US)
- University of North Carolina at Chapel Hill (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-08-06
- Volume
- 373
- Issue
- 6
- Pages
- 530-539
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4562018
- OpenAlex
- W1941748532
- Cited by
- 92
- References
- 24
- Citations by year
- 2026: 2 · 2025: 7 · 2024: 4 · 2023: 4 · 2022: 10 · 2021: 12 · 2020: 6 · 2019: 4 · 2018: 7 · 2017: 18 · 2016: 12 · 2015: 6
- FWCI
- 11.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- ResearchSpace (University of KwaZulu-Natal) (submittedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (U19AI051794, AI 51794)
- Fogarty International Center (D43-TW00231, D43TW000231)
- Topics
- Health Sciences › Medicine › Epidemiology › Herpesvirus Infections and Treatments
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Keywords
- tenofovir gel, herpes simplex virus type 2, microbicides, seroconversion, HSV-2 incidence, sexually transmitted infections, women, vaginal microbicides, HIV prevention, South Africa
- MeSH terms
- Tenofovir, Adenine, Administration, Intravaginal, Adult, Double-Blind Method, Female, Follow-Up Studies, Gels, Herpes Genitalis, Humans, HIV Infections, Incidence, HIV Seronegativity, Herpesvirus 2, Human, Reverse Transcriptase Inhibitors, Kaplan-Meier Estimate, Young Adult, Organophosphonates
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