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Oral Famciclovir for Suppression of Recurrent Genital Herpes Simplex Virus Infection in Women: A Multicenter, Double-Blind, Placebo-Controlled Trial
Abstract
Objective: To evaluate the efficacy and safety of oral famciclovir in the suppression of genital herpes. Methods: In this randomized, double-blind, placebo-controlled trial that was performed at 11 university and 9 private ambulatory care referral centers, 375 women who were 18 years of age or older and had a history of 6 or more episodes of genital herpes during 12 of the last 24 months in the absence of suppressive therapy were treated for 4 months with oral famciclovir, 125 mg once daily or twice daily, 250 mg once daily or twice daily, 500 mg once daily, or placebo. The primary outcome measures included the time to first clinically and virologically confirmed recurrences, and safety as measured by clinical laboratory tests and adverse experiences. Results: The median time to first recurrence was 82 days in the placebo group, 114 days in those receiving famciclovir, 125 mg once daily, and more than 120 days in the other treatment groups. When compared with placebo recipients, the time to the first clinical recurrence was significantly prolonged in subjects who received famciclovir, 125 mg twice daily (hazard ratio, 1.8; 95% confidence interval, 1.0-3.0;P=.03), and in those who received famciclovir, 250 mg twice daily (hazard ratio, 3.6; 95% confidence interval, 1.9-6.9;P<.001). Treatment was well tolerated, and there was no evidence of emergence of resistance during or after suppressive famciclovir therapy. Conclusions: Oral famciclovir, 250 mg, given twice daily for 4 months is an effective, well-tolerated treatment for the suppression of genital herpes in women with frequent recurrences, but single daily doses produced less complete suppression of genital herpes. Arch Intern Med. 1997;157:343-349
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“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 [470]
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Self-citationSuppression of Frequently Recurring Genital Herpes
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Sorted by citations
Sexually Transmitted Infections Treatment Guidelines, 2021
Workowski, K. A., Bachmann, L. H., Chan, P. A., Johnston, C. M., Muzny, C. A., Park, I., Reno, H., Zenilman, J. M., & Bolan, G. A. (2021) · MMWR. Recommendations and Reports · doi:10.15585/mmwr.rr7004a1 · Cited by 3,018
Seley‐Radtke, K. L., & Yates, M. K. (2018) · Antiviral Research · doi:10.1016/j.antiviral.2018.04.004 · Cited by 547
Antiviral prodrugs – the development of successful prodrug strategies for antiviral chemotherapy
Clercq, E. D., & Field, H. J. (2005) · British Journal of Pharmacology · doi:10.1038/sj.bjp.0706446 · Cited by 332
“…famciclovir has been established to be effective against HSV-1-and -2 for both therapy and long-term suppression of recurrences (Sacks et al., 1996; Mertz et al., 1997) and is also claimed to be efficacious in treatment of herpes zoster (Degreef & Famciclovir Herpes Zoster Clinical Study Group,…”
BackgroundOral Acyclovir Suppression and Neurodevelopment after Neonatal Herpes
Kimberlin, D. W., Whitley, R. J., Wan, W., Powell, D. A., Storch, G. A., Ahmed, A. I., Palmer, A., Sánchez, P. J., Jacobs, R. F., Bradley, J. S., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1003509 · Cited by 313
Treatment of herpes simplex virus infections
Brady, R. C., & Bernstein, D. I. (2003) · Antiviral Research · doi:10.1016/j.antiviral.2003.09.006 · Cited by 233
Metadata
- Authors
- Mertz, G. J.
- Corresponding author
- Mertz, Gregory J.
- ORCID
- Mertz, Gregory J.
- Venue
- Archives of Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 1997-02-10
- Volume
- 157
- Issue
- 3
- Pages
- 343
- ISSN
- 0003-9926 (ISSN-L)
- OpenAlex
- W2059870306
- Cited by
- 121
- References
- 29
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2023: 4 · 2021: 3 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 7 · 2015: 3 · 2014: 3 · 2013: 1 · 2012: 3
- FWCI
- 8.86
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Internal Medicine (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Herpesvirus Infections and Treatments
- Health Sciences › Medicine › Epidemiology › Cytomegalovirus and herpesvirus research
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Keywords
- famciclovir, genital herpes simplex virus, recurrent herpes, suppressive therapy, oral antiviral therapy, women, time to recurrence, dose comparison, drug safety, drug resistance
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