Valaciclovir for the suppression of recurrent genital herpes simplex virus infection: a large-scale dose range-finding study.
Abstract
A randomized, double-blind study of valaciclovir for suppression of recurrent genital herpes was conducted among 1479 immunocompetent patients. Patients were randomized to receive valaciclovir (250 mg, 500 mg, or 1 g once daily, or 250 mg twice daily), acyclovir (400 mg twice daily), or placebo, for 1 year. All valaciclovir dosages were significantly more effective than placebo at preventing or delaying recurrences (P < .0001). There was a dose-response relationship (P < .0001) across the once-daily valaciclovir regimens. Twice-daily valaciclovir and acyclovir were similar in effectiveness. Subgroup analysis showed that patients with a history of < 10 recurrences per year were effectively managed with 500 mg of valaciclovir once daily. One gram of valaciclovir once daily, 250 mg of valaciclovir twice daily, or 400 mg of acyclovir twice daily were more effective in patients with > or = 10 recurrences per year. Safety profiles of all treatments were comparable. Thus, valaciclovir is highly effective and well tolerated for suppression of recurrent genital herpes. Once-daily regimens offer a useful option for patients who require suppressive therapy for management of genital herpes.
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Suppressive therapy reduces frequency of genital herpes recurrences by 70%-80% among patients who have frequent recurrences.
“Suppressive therapy reduces frequency of genital herpes recurrences by 70%–80% among patients who have frequent recurrences (469–472).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [471]
The subgroup analysis (Table 3, page unavailable) reports placebo-comparison hazard ratios of 0.26–0.33 for time to first recurrence in patients with at least 10 recurrences per year—roughly a 67%–74% lower hazard with certain suppressive regimens. This supports a substantial benefit in frequently recurring disease, but the paper does not establish the claimed 70%–80% reduction in the frequency of recurrences; time to first recurrence is a different measure. (LLM, conf=0.86)
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References 12 · Cited by 209
Research works printed but not linked: 4
- Nahmias AJ, Lee FK, Beckman-Nahmias S. Seroepidemiological and so- per year, in terms of clinical efficacy, there was little to differ- ciological patterns of herpes virus infection in the world. Scand J Infect entiate the outcomes of a regimen of 500 mg of valaciclovir Dis Suppl 1990; 69:19 -36.
- Wagstaff AJ, Faulds D, Goa KL. Acyclovir: a reappraisal of its antiviral The safety profile of valaciclovir at all dosages was similar activity, pharmacokinetic properties and therapeutic efficacy. Drugs to those of acyclovir and placebo; reported adverse experiences 1994; 47:153 -205.
- to R. Toorawa for the statistical analysis, S. Weller for the pharma- using the log rank test. Stat Med 1982; 1:121 -9.
- cokinetic analysis, and A. J. Ingamells, A. R. Bell, and R. J. Crooks 16. Mertz GJ, Jones CC, Mills J, et al. Long-term acyclovir suppression of for their contributions to both the design and conduct of the study frequently recurring genital herpes simplex virus infection. JAMA 1988; 260:201 -6. and to preparation of this manuscript.
- Authors
- Reitano, M., Tyring, S., Lang, W., Thoming, C., Worm, A. ‐., Borelli, S., Chambers, L. O., Robinson, J. M., Corey, L., & the International Valaciclovir HSV Study Group
- Affiliations
- University of Washington (US)
- GlaxoSmithKline (United Kingdom) (GB)
- ORCID
- Venue
- The Journal of Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 1998-09
- Volume
- 178
- Issue
- 3
- Pages
- 603-610
- ISSN
- 0022-1899 (ISSN-L)
- 1537-6613
- OpenAlex
- W2076699464
- Cited by
- 209
- References
- 12
- Citations by year
- 2026: 3 · 2025: 8 · 2024: 3 · 2023: 5 · 2022: 5 · 2021: 5 · 2020: 3 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 10 · 2015: 4 · 2014: 5 · 2012: 5
- FWCI
- 10.70
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Herpesvirus Infections and Treatments
- Health Sciences › Medicine › Epidemiology › Cytomegalovirus and herpesvirus research
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Keywords
- valacyclovir, recurrent genital herpes, herpes simplex virus, suppressive therapy, acyclovir, dose-response relationship, once-daily dosing, antiviral efficacy, drug safety, immunocompetent patient
- MeSH terms
- Valacyclovir, Acyclovir, Adolescent, Adult, Aged, Aged, 80 and over, Antiviral Agents, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Herpes Simplex, Humans, Male, Recurrence, Valine, Treatment Outcome, Simplexvirus
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