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Oral Famciclovir for the Suppression of Recurrent Genital Herpes<SUBTITLE>A Randomized Controlled Trial</SUBTITLE>
Abstract
CONTEXT: Recurrent genital herpes simplex virus (HSV) may be treated episodically, but this may not be sufficient for patients with frequent recurrences. OBJECTIVE: To determine the efficacy and safety of famciclovir in the suppression of recurrent genital HSV infection. DESIGN: A randomized, double-blind, placebo-controlled, parallel-group study. SETTING: Thirty university, hospital, or private outpatient referral centers in Canada and Europe. PATIENTS: A total of 455 patients (223 men, 232 women) aged 18 years or older with a history of 6 or more episodes of genital herpes during 12 of the most recent 24 months, in the absence of suppressive therapy, received study medication. INTERVENTION: Oral famciclovir, 125 mg or 250 mg 3 times daily or 250 mg twice daily, or placebo for 52 weeks. MAIN OUTCOME MEASURES: Time to the first recurrence of genital HSV infection; the proportion of patients remaining free of HSV recurrence at 6 months; frequency of adverse events. RESULTS: In an intent-to-treat analysis, famciclovir significantly delayed the time to the first recurrence of genital herpes at all dose regimens (hazard ratios, 2.9-3.3; P<.001); median time to recurrence for famciclovir recipients was 222 to 336 days compared with 47 days for placebo recipients. The proportion of patients remaining free of HSV recurrence was approximately 3 times higher in famciclovir recipients (79%-86%) than in placebo recipients (27%) at 6 months (relative risks, 2.9-3.1; P<.001); efficacy was maintained at 12 months. Famciclovir was well tolerated with an adverse experience profile comparable to placebo. CONCLUSIONS: Oral famciclovir (125 mg or 250 mg 3 times daily or 250 mg twice daily) is an effective, well-tolerated treatment for the suppression of genital HSV infection in patients with frequent recurrences.
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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 [469]
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Metadata
- Authors
- Diaz-Mitoma, F.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 1998-09-09
- Volume
- 280
- Issue
- 10
- Pages
- 887
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2083993202
- Cited by
- 147
- References
- 24
- Citations by year
- 2026: 3 · 2025: 4 · 2023: 4 · 2022: 2 · 2021: 7 · 2019: 2 · 2017: 1 · 2016: 4 · 2015: 3 · 2014: 3 · 2013: 7 · 2012: 3
- FWCI
- 9.26
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Háskóli Íslands
- 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, recurrent genital herpes, herpes simplex virus, suppressive therapy, antiviral therapy, time to recurrence, adverse events, dose comparison
- MeSH terms
- Famciclovir, Administration, Oral, Adult, Aged, Antiviral Agents, Double-Blind Method, Female, Herpes Genitalis, Humans, Male, Middle Aged, Recurrence, 2-Aminopurine, Proportional Hazards Models, Statistics, Nonparametric
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