Peroral Famciclovir in the Treatment of Experimental Ultraviolet Radiation–Induced Herpes Simplex Labialis: A Double‐Blind, Dose‐Ranging, Placebo‐Controlled, Multicenter Trial

Spruance, Spotswood L.; Rowe, Nathaniel H.; Raborn, G. Wayne; Thibodeau, E A; D'Ambrosio, Joseph A.; Bernstein, David I.

doi:10.1086/314605

Cited by 56 publications

(46 citation statements)

References 36 publications

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“…The lips of the patients were exposed to UVR (study day 0) within 7 days of the initial reading. The half of the lips (either the lower lip, the upper lip, or the right or left portions of both the lower and upper lips) that was regarded as the usual site of recurrence was exposed to UVR as described above for a duration four times the MED, as described previously (3,8,11). The remainder of the lips and the perioral skin outside this zone were covered with a para-aminobenzoic acidcontaining sunscreen with a sun protection factor of at least 30.…”

Section: Study Medicationmentioning

confidence: 99%

Double-Blind, Randomized, Placebo-Controlled Study of Topical 5% Acyclovir-1% Hydrocortisone Cream (ME-609) for Treatment of UV Radiation-Induced Herpes Labialis

Evans

Bernstein²,

Raborn

et al. 2002

Antimicrob Agents Chemother

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Immunopathology is recognized as an important component of infectious disease manifestations, and corticosteroids have been used as an adjunct to antimicrobial therapy for a variety of conditions. Antiviral therapy of herpes labialis has been shown to result in only a small reduction in the time to healing and the duration of pain. To determine if topical application of a combination product containing 5% acyclovir and 1% hydrocortisone (ME-609) could provide benefit to herpes labialis patients, 380 immunocompetent adults with a history of herpes labialis were exposed to experimental UV radiation (UVR) to induce a recurrence. On day 2, just before the appearance of the majority of lesions ("delayed" lesions), subjects were randomized to receive active medication or vehicle control six times per day for 5 days. Overall, 120 of 380 patients developed delayed classical lesions, of whom 50 of 190 (26%) had been treated with ME-609 and 70 of 190 (37%) had received placebo (a reduction of 29% [P ‫؍‬ 0.02]). Healing time, measured as the time to normal skin, was reduced by treatment with ME-609 (9.0 days for treated patients versus 10.1 days for the controls [P ‫؍‬ 0.04]). There was a trend toward a reduction in the maximum lesion size in the ME-609 recipients compared to that in the controls (43 versus 60 mm 2 , respectively [P ‫؍‬ 0.07]). The treatment had no effect on lesion pain, but ME-609 treatment reduced the number of patients with moderate or severe tenderness. Compared to treatment with a placebo, treatment with the combination antiviral-immunomodulatory cream provided benefit to patients with experimental UVR-induced herpes labialis, reducing classical lesion incidence, healing time, lesion size, and lesion tenderness. ME-609 is a novel product that merits further evaluation as a treatment for cold sores.Treatment of herpes simplex virus (HSV) infections with antiviral drugs has been a major challenge for investigators for more than 30 years. The benefits of treatment of recurrent HSV infection have been modest in contrast to the benefits of treatment of primary infection. The main clinical benefit in the treatment of recurrences has been the modest reduction in lesion healing time of approximately 10 to 15% (5, 10). Recurrent disease differs from the primary episode in that the virus is cleared much more rapidly, usually within 3 days or less. Although the immune response is quicker and more effective in controlling recurrent disease, it also may be responsible for most of the clinical symptoms, which persist for up to a week after the virus can no longer be isolated (6, 9). Thus, a combined modality of therapy aimed at both an antiviral effect and an immunomodulatory effect has been proposed in a number of studies (1, 9).The availability of a small-animal model for evaluation of the effects of treatment on the severity of recurrent lesions has been a limiting factor in evaluations of therapy. A novel animal model of recurrent HSV disease was recently developed by the use of zosteriform HSV infection in mic...

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Section: Study Medicationmentioning

confidence: 99%

Double-Blind, Randomized, Placebo-Controlled Study of Topical 5% Acyclovir-1% Hydrocortisone Cream (ME-609) for Treatment of UV Radiation-Induced Herpes Labialis

Evans

Bernstein²,

Raborn

et al. 2002

Antimicrob Agents Chemother

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“…Clinical trials have shown that FCV is effective in the treatment of acute herpes labialis and genital herpes (39,41) and as a prophylactic treatment of UV-induced herpes labialis, excimer laser skin resurfacing, and genital herpes (2,11,43,44). We report that FCV may be beneficial in reducing corneal morbidity in patients with recurrent herpes keratitis.…”

Section: Vol 45 2001 Fcv Effect On Hsv Corneal Disease and Latencymentioning

confidence: 80%

“…FCV is currently approved for the treatment of herpes zoster and the treatment and suppression of genital herpes (7,9). FCV has also been used in clinical trials for herpes labialis (2,8,11,39,41,43,44). A clinical trial by Spruance et al (44) demonstrated that oral FCV decreased the median lesion size in a dose-dependent manner and that, at higher doses, it decreased the time to healing following UV radiation-induced HSV labialis.…”

mentioning

confidence: 99%

Effect of famciclovir on herpes simplex virus type 1 corneal disease and establishment of latency in rabbits

Loutsch

Sáinz²,

Marquart³

et al. 2001

American Journal of Ophthalmology

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“…Therefore, 2 to 36% of nucleoside analogue usage may have been for oral or labial HSV-1; if one can extrapolate from the prescriptions that did specify the site of infection, then the actual percentage used for RHL is near the low end of this interval. In calculating the figures in scenario 1 for Table 2, we used data on the reduction of HSV-1 shedding in treated patients from efficacy trials to calculate the effect of the fraction of treatment that is directed against herpes labialis or gingivostomatitis (2,52,53). We assumed that the use of these compounds to treat other conditions would affect HSV-1 shedding as if the recipients were taking the drug to suppress RHL (44,51,57).…”

Section: Methodsmentioning

confidence: 99%

“…There are two approaches to the therapy of RHL: episodic treatment of a single symptomatic outbreak, which reduces the duration of symptoms and viral shedding (2,50,52,53), and long-term suppressive therapy, which reduces the frequency of recurrences (44,51). Although neither ACV nor PCV is approved for long-term suppression of RHL, topical PCV has been approved in the United States for treatment of RHL, and in other countries topical ACV and topical PCV are available.…”

mentioning

confidence: 99%

Effects of Antiviral Usage on Transmission Dynamics of Herpes Simplex Virus Type 1 and on Antiviral Resistance: Predictions of Mathematical Models

Lipsitch

Bacon²,

Leary³

et al. 2000

Antimicrob Agents Chemother

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Herpes simplex virus type 1 (HSV-1) causes recurrent herpes labialis (RHL), a common disease afflicting up to 40% of adults worldwide. Mathematical models are used to analyze the effect of antiviral treatment on the transmission of, and the prevalence of drug resistance in, HSV-1 in the United States. Three scenarios are analyzed: no antiviral use, the current level of use, and a substantial increase in nucleoside analogue use, such as might occur if topical penciclovir were available over-the-counter for the treatment of RHL. A basic model predicts that present level of nucleoside analogue use has a negligible effect on HSV-1 transmission and that even if use of topical penciclovir for (RHL) increased substantially, the overall prevalence of infectious HSV-1 is unlikely to be reduced by more than 5%. An expanded model, which allows for acquired resistance and includes immunocompromised hosts and other more realistic features, predicts that current antiviral use is unlikely to lead to any noticeable increase in resistance. If antiviral use increases, the resulting rise in resistance in the population will depend primarily on the probability that immunocompetent hosts will acquire permanent resistance upon treatment. This probability is known to be small, but its exact value remains uncertain. If acquired resistance occurs less than once per 2,500 treated episodes, then in the community at large, the frequency of HSV-1 resistance is predicted to increase slowly, if at all (remaining below 0.5% for >50 years), even with extensive nucleoside analogue use. If acquired resistance emerges in 1 of 625 treated episodes (the maximum of an approximate 95% confidence interval derived from the results of several studies of resistance in treated hosts), then the prevalence of infection with resistant HSV-1 could rise from about 0.2% to 1.5 to 3% within 50 years. The limitations of existing data on acquired resistance and the potential impact of acquired resistance if it occurs are discussed, and strategies are suggested for enhancing information on acquired resistance. The predictions of this model contrast with the more rapid increases in antimicrobial resistance anticipated by models and observed for other pathogenic bacteria and viruses. The reasons for these contrasting predictions are discussed.

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Peroral Famciclovir in the Treatment of Experimental Ultraviolet Radiation–Induced Herpes Simplex Labialis: A Double‐Blind, Dose‐Ranging, Placebo‐Controlled, Multicenter Trial

Cited by 56 publications

References 36 publications

Double-Blind, Randomized, Placebo-Controlled Study of Topical 5% Acyclovir-1% Hydrocortisone Cream (ME-609) for Treatment of UV Radiation-Induced Herpes Labialis

Double-Blind, Randomized, Placebo-Controlled Study of Topical 5% Acyclovir-1% Hydrocortisone Cream (ME-609) for Treatment of UV Radiation-Induced Herpes Labialis

Effect of famciclovir on herpes simplex virus type 1 corneal disease and establishment of latency in rabbits

Effects of Antiviral Usage on Transmission Dynamics of Herpes Simplex Virus Type 1 and on Antiviral Resistance: Predictions of Mathematical Models

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