Once-daily valacyclovir to reduce the risk of transmission of genital herpes.
Open accessAbstract
BACKGROUND: Nucleoside analogues against herpes simplex virus (HSV) have been shown to suppress shedding of HSV type 2 (HSV-2) on genital mucosal surfaces and may prevent sexual transmission of HSV. METHODS: We followed 1484 immunocompetent, heterosexual, monogamous couples: one with clinically symptomatic genital HSV-2 and one susceptible to HSV-2. The partners with HSV-2 infection were randomly assigned to receive either 500 mg of valacyclovir once daily or placebo for eight months. The susceptible partner was evaluated monthly for clinical signs and symptoms of genital herpes. Source partners were followed for recurrences of genital herpes; 89 were enrolled in a substudy of HSV-2 mucosal shedding. Both partners were counseled on safer sex and were offered condoms at each visit. The predefined primary end point was the reduction in transmission of symptomatic genital herpes. RESULTS: Clinically symptomatic HSV-2 infection developed in 4 of 743 susceptible partners who were given valacyclovir, as compared with 16 of 741 who were given placebo (hazard ratio, 0.25; 95 percent confidence interval, 0.08 to 0.75; P=0.008). Overall, acquisition of HSV-2 was observed in 14 of the susceptible partners who received valacyclovir (1.9 percent), as compared with 27 (3.6 percent) who received placebo (hazard ratio, 0.52; 95 percent confidence interval, 0.27 to 0.99; P=0.04). HSV DNA was detected in samples of genital secretions on 2.9 percent of the days among the HSV-2-infected (source) partners who received valacyclovir, as compared with 10.8 percent of the days among those who received placebo (P<0.001). The mean rates of recurrence were 0.11 per month and 0.40 per month, respectively (P<0.001). CONCLUSIONS: Once-daily suppressive therapy with valacyclovir significantly reduces the risk of transmission of genital herpes among heterosexual, HSV-2-discordant couples.
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Treatment with valacyclovir 500 mg daily decreases the rate of HSV-2 transmission for discordant heterosexual couples in which a partner has a history of genital HSV-2 infection.
“Treatment with valacyclovir 500 mg daily decreases the rate of HSV-2 transmission for discordant heterosexual couples in which a partner has a history of genital HSV-2 infection (473).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [473]
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- Authors
- Corey, L., Wald, A., Patel, R., Sacks, S. L., Tyring, S. K., Warren, T., Douglas, J. M., Paavonen, J., Morrow, R. A., Beutner, K. R., Stratchounsky, L. S., Mertz, G., Keene, O. N., Watson, H. A., Tait, D., & Vargas-Cortes, M.
- Affiliations
- University of Washington (US)
- Royal South Hants Hospital (GB)
- University of British Columbia (CA)
- The University of Texas Medical Branch at Galveston (US)
- Westover Heights Clinic (US)
- University of Helsinki (FI)
- University of California, San Francisco (US)
- University of New Mexico (US)
- GlaxoSmithKline (United Kingdom) (GB)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2004-01
- Volume
- 350
- Issue
- 1
- Pages
- 11-20
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2083083619
- Cited by
- 720
- References
- 35
- Citations by year
- 2026: 16 · 2025: 13 · 2024: 14 · 2023: 27 · 2022: 18 · 2021: 17 · 2020: 21 · 2019: 16 · 2018: 15 · 2017: 26 · 2016: 31 · 2015: 31 · 2014: 31 · 2013: 33 · 2012: 39
- FWCI
- 36.25
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Allergy and Infectious Diseases (AI 30731, P01AI030731)
- Topics
- Health Sciences › Medicine › Epidemiology › Herpesvirus Infections and Treatments
- Health Sciences › Medicine › Epidemiology › Cytomegalovirus and herpesvirus research
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Keywords
- valacyclovir, genital herpes, herpes simplex virus type 2, HSV-2 transmission, suppressive antiviral therapy, once-daily dosing, condom use
- MeSH terms
- Valacyclovir, Acyclovir, Adolescent, Adult, Aged, Antiviral Agents, Drug Administration Schedule, Female, Herpes Genitalis, Humans, Male, Middle Aged, Valine, Virus Activation, Herpesvirus 2, Human, Disease Transmission, Infectious, Safe Sex
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