ReportSingle-dose, patient-initiated famciclovir: A randomized, double-blind, placebo-controlled trial for episodic treatment of herpes labialis
Section snippets
Study design
This multinational, multicenter, randomized, double-blind, placebo-controlled study of patient-initiated therapy assessed famciclovir (1500 mg once [single dose] and 750 mg twice a day for 1 day [single day]) in immunocompetent adults with recurrent herpes labialis. The study was conducted at 28 centers in the United States, 10 centers in Canada, and 3 centers in Australia from October 2003 to January 2005. The protocol and patient consent forms were approved by the institutional and/or central
Results
A total of 1417 patients were screened, of whom 1376 met the entry criteria and were randomized and given study medication. In all, 701 patients had symptoms of a recurrence, started study medication, and were analyzed in the safety (ITT) population. In all, 477 patients developed vesicles (mITT population), and 375 patients developed vesicles and had no major protocol violations (PP population). The most common violations were related to noncompliance with study medication instructions, such
Discussion
The results of this study demonstrated that a single 1500-mg dose of patient-initiated famciclovir is both effective and safe for recurrent herpes labialis. Single-dose famciclovir reduced the time to healing (loss of crust and re-epithelialization) of vesicular herpes labialis lesions and the time to return to normal skin of all lesions by approximately 2 days compared with placebo. In addition, single-dose famciclovir resolved the pain and tenderness associated with a herpes labialis outbreak
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Cited by (82)
COMPARATIVE EFFICACY OF ANTIVIRAL AGENTS FOR PREVENTION AND MANAGEMENT OF HERPES LABIALIS: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS
2023, Journal of Evidence-Based Dental PracticeCitation Excerpt :The frequencies of treatment given varied from 3 to 6 times daily, some as often as 8 times daily or every 2 hours.28,31,49,52,67 Two studies required application only once at the start of trial 62,70 while several studies had specified instructions to follow throughout the trial duration.20,21,25,38,41,44,48,60,66,69 All the outcomes of interest are described in detail in supplementary Table 8.
Systemic calicivirus infection successfully treated with famciclovir in two cats
2016, Revue Veterinaire CliniqueCitation Excerpt :Famciclovir was developed to increase bioavailability of its active metabolite, penciclovir, in humans disease due to herpesvirus simplex type 1 and genital herpes simplex type 2, varicella zoster virus and Epstein–Barr virus [13]. Famciclovir can reduce the time to remission of clinical signs due to herpes simplex virus HSV-1 [14,15] or HSV-2 [16,17]. In cells infected by α-herpesviruses, virus-induced thymidine kinase converts penciclovir into penciclovir triphosphate, which competitively inhibits viral DNA polymerase, preventing DNA chain elongation.
The Pharmacologic Management of Common Lesions of the Oral Cavity
2016, Dental Clinics of North AmericaCitation Excerpt :For recurrent herpes labialis, the most common topical treatment options are acyclovir22 and pencyclovir23 (Table 3). Because of the need of frequent applications, oral formulations are available for acyclovir,24 famciclovir,25 and valacyclovir.26 For prophylaxis treatment, such as before dental procedures, valacyclovir (1 g or 2 g twice a day) or acyclovir (400 mg two or three times a day) can be prescribed.21
Clinical and antiviral effect of a single oral dose of famciclovir administered to cats at intake to a shelter
2015, Veterinary JournalCitation Excerpt :Therefore, it is likely that viral reactivation had already occurred in these cats at the time of intake at the shelter where the study was conducted and that administration of famciclovir was therapeutic rather than prophylactic. If viral reactivation had not yet occurred on day 1 of the study, it is possible that a single dose of famciclovir might have been more efficacious, as was the case when used as a prophylactic drug in humans with genital herpesvirus infections (Aoki et al., 2006; Spruance et al., 2006). Doses in the current trial were selected for their potential economic and logistic advantages.
Antivirals against Herpes Viruses
2014, Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases
Novartis provided statistical and other analyses and the study medication (active and placebo).
Disclosure: Dr Spruance has received research funding from, was an investigator for, and has been a scientific consultant for Novartis. Dr Bodsworth has been a scientific consultant for, has received research funding from, and was an investigator for Novartis. Drs Resnick and Conant have been research investigators for Novartis. Drs Oeuvray, Gao, and Hamed are employees of Novartis.
Presented at the European Academy of Dermatology and Venereology, October 13, 2005, London, England, and the American Academy of Dermatology Congress, March 4, 2006, San Francisco, California.