Effective treatment of herpes simplex labialis with penciclovir cream

Raborn, G. Wayne; Martel, Alain; Lassonde, M.; Lewis, Michael Alexander Oxenham; Boon, R. J.; Spruance, Spotswood L.

doi:10.14219/jada.archive.2002.0169

Cited by 50 publications

(34 citation statements)

References 10 publications

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“…It is presumed, but not proven, that a strong antiviral effect hastens wound resolution by decreasing the extent of keratinocyte destruction, the viral antigen load, and the attendant inflammatory response, which impair reepithelization at the site of infection (1,9,11,22). One-day, two-dose oral valacyclovir constitutes a convenient treatment for herpes labialis in comparison to topical therapies, which typically require frequent applications for multiple days (13,15,19,20,23). While direct comparisons between oral and topical therapy have not been conducted, the available data suggest that oral therapy is more effective.…”

Section: Discussionmentioning

confidence: 99%

“…Penciclovir 1% cream (Denavir) is indicated for the treatment of cold sores. The clinical studies leading to approval demonstrated that the cream was efficacious in shortening the median healing time of classical cold sore episodes by 0.7 to 1.0 days (13 to 17%) compared to the vehicle controls (13,20). Acyclovir 5% cream (Zovirax cream) is also indicated for cold sores and has been shown in two large, well-controlled clinical trials to shorten the duration of classical cold sore episodes by a similar magnitude to that of penciclovir 1% cream (19).…”

Section: Discussionmentioning

confidence: 99%

“…The infection is most often acquired in childhood, but the incidence increases with age (2, 5, 12, 18). Up to 90% of persons over the age of 50, depending on race, sex, and country, would test seropositive for HSV-1, and an estimated 20 to 40% of adults experience cold sore outbreaks (5,12,18,25).Until now, most treatments have consisted of creams that must be applied to affected areas multiple times a day for several days (6,13,15,19,20,23). There have been two previous clinical trials of oral antiviral therapy for episodic treatment of herpes labialis.…”

mentioning

confidence: 99%

“…Until now, most treatments have consisted of creams that must be applied to affected areas multiple times a day for several days (6,13,15,19,20,23). There have been two previous clinical trials of oral antiviral therapy for episodic treatment of herpes labialis.…”

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confidence: 99%

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High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

Spruance

Jones

Blatter

et al. 2003

Antimicrob Agents Chemother

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102

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Oral valacyclovir is better absorbed than oral acyclovir, increasing acyclovir bioavailability three-to fivefold. This provides the opportunity to explore whether high systemic acyclovir concentrations are effective in the treatment of cold sores (herpes labialis). Two randomized, double-blind, placebo-controlled studies were conducted. Subjects were provided with 2 g of valacyclovir twice daily for 1 day (1-day treatment), 2 g of valacyclovir twice daily for 1 day and then 1 g of valacyclovir twice daily for 1 day (2-day treatment), or a matching placebo and instructed to initiate treatment upon the first symptoms of a cold sore. In study 1, the median duration of the episode (primary endpoint) was reduced by 1.0 day (P ‫؍‬ 0.001) with 1-day treatment and 0.5 days (P ‫؍‬ 0.009) with 2-day treatment compared to placebo. Similarly, the mean duration of the episode was statistically significantly reduced by 1.1 days with 1-day treatment and 0.7 days with 2-day treatment compared to placebo. The proportion of subjects in whom cold sore lesion development was prevented and/or blocked was increased by 6.4% (P ‫؍‬ 0.096) with 1-day treatment and 8.5% (P ‫؍‬ 0.061) with 2-day treatment compared to placebo. The time to lesion healing and time to cessation of pain and/or discomfort were statistically significantly reduced with valacyclovir compared to placebo. In study 2, results similar to those in study 1 were obtained. AEs were similar across treatment groups. These studies provide evidence supporting a simple, 1-day valacyclovir treatment regimen for cold sores that is safe and effective. The 1-day valacyclovir regimen offers patients a unique and convenient dosing alternative compared to available topical therapies.Herpes labialis, or cold sores, are caused by herpes simplex virus type 1 (HSV-1) and can result in significant irritation, pain, discomfort, and worry (18,25). The infection is most often acquired in childhood, but the incidence increases with age (2, 5, 12, 18). Up to 90% of persons over the age of 50, depending on race, sex, and country, would test seropositive for HSV-1, and an estimated 20 to 40% of adults experience cold sore outbreaks (5,12,18,25).Until now, most treatments have consisted of creams that must be applied to affected areas multiple times a day for several days (6,13,15,19,20,23). There have been two previous clinical trials of oral antiviral therapy for episodic treatment of herpes labialis. In a double-blind, placebo-controlled trial involving 210 subjects with recurrent cold sores, it appeared that less time was required for the loss of hard crust for subjects taking 200 mg of oral acyclovir 5 times daily for 5 days (14). This difference as well as other measures of clinical healing was not statistically significant. Spruance et al. evaluated a regimen of 400 mg of oral acyclovir 5 times daily for 5 days in comparison with placebo (21). Overall in this study, acyclovir did not affect the duration of the episode, mean maximum lesion size, or the development of lesions, but a subset o...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

Spruance

Jones

Blatter

et al. 2003

Antimicrob Agents Chemother

Self Cite

102

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show abstract

“…Penciclovir 1% cream (Denavir ® ) and acyclovir 5% cream (Zovirax ® ) are the two available prescription topical agents. Penciclovir 1% cream has been shown in 3 randomized, double-blind, placebo-controlled trials to shorten median healing time of cold sores by 0.7-1 day and pain duration by 0.6-0.8 days compared to vehicle controls (Spruance Table 1 Effi cacy of single-day famciclovir compared to standard 2-to 5-day antiviral regimens in the treatment of recurrent genital herpes et al 1997; Raborn et al 2002). Subjects in the penciclovir studies applied medication to the affected area within 1 hour of prodrome onset and continued to do so every 2 hours for 4 consecutive days.…”

Section: Treatment Options For Orolabial Herpes Topical Agentsmentioning

confidence: 99%

Single-day treatment for orolabial and genital herpes: a brief review of pathogenesis and pharmacology

Tyring¹

2008

TCRM

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Herpes simplex virus (HSV) infection is a highly prevalent condition responsible for signifi cant morbidity and occasional mortality each year. Approximately half of all patients infected by HSV will experience at least one recurrence in their lifetime. For these recurrences, traditional therapy has included both suppressive and episodic treatment with nucleoside analogs. In regards to episodic treatment, 2-to 5-day oral regimens are best studied and most commonly reported. As with any medical condition having a well-understood mechanism of action and targeted treatment, therapeutic intervention is only as effective as allowed by patient compliance. Based on these concerns, recent studies have focused on shorter, less complicated, and more affordable options. This review delineates the evidence for single-day treatments of orolabial and genital herpes. Randomized, double-blind studies of both valacyclovir and famciclovir as single-day episodic therapy for HSV have been reported in the literature. Although no headto-head studies between the drugs have been performed, both regimens produced signifi cant improvement in healing time and symptom resolution over placebo. Single-day therapy for HSV infection is appealing for multiple reasons. First, it simplifi es the regimen, increasing likelihood of patient compliance. Additionally, it allows complete delivery of the medication at the onset of symptoms, when viral replication is highest and intervention has greatest effect. Lastly, the reduced number of pills necessary for single versus multiple day therapy decreases the overall cost of treatment per episode, an important factor in modern-day healthcare.

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The Treatment of Herpes Simplex Infections<subtitle>An Evidence-Based Review</subtitle>

Cernik¹

2008

Arch Intern Med

169

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enital and labial herpes simplex virus infections are frequently encountered by primary care physicians in the United States. Whereas the diagnosis of this condition is often straightforward, choosing an appropriate drug (eg, acyclovir, valacyclovir hydrochloride, or famciclovir) and dosing regimen can be confusing in view of (1) competing clinical approaches to therapy; (2) evolving dosing schedules based on new research;(3) approved regimens of the Food and Drug Administration that may not match recommendations of the Centers for Disease Control and Prevention or of other experts; and (4) dissimilar regimens for oral and genital infections. The physician must first choose an approach to treatment (ie, intermittent episodic therapy, intermittent suppressive therapy, or chronic suppressive therapy) based on defined clinical characteristics and patient preference. Then, an evidence-based dosing regimen must be selected. In this review, data from all sources are tabulated to provide a handy clinical reference.

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Effective treatment of herpes simplex labialis with penciclovir cream

Cited by 50 publications

References 10 publications

High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

Single-day treatment for orolabial and genital herpes: a brief review of pathogenesis and pharmacology

The Treatment of Herpes Simplex Infections<subtitle>An Evidence-Based Review</subtitle>

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