Oral acyclovir and herpes labialis: a randomized, double-blind, placebo-controlled study

Raborn, G. Wayne; McGaw, William T.; Grace, Michael; Tyrrell, Laila; Samuels, Sheri M.

doi:10.14219/jada.archive.1987.0211

Cited by 73 publications

(34 citation statements)

References 13 publications

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“…Two studies, one using topical acyclovir cream and one using oral acyclovir, have shown some apparent effect on the prevention of cold sore lesion progression (6,16). However, these results have not been reproduced in subsequent studies (14,19,21). The present valacyclovir studies are the two largest, placebo-controlled trials of herpes labialis treatment designed to test the hypothesis that the progression of cold sore lesions could be prevented with oral medication if taken early (i.e., at the first symptoms).…”

Section: Discussionmentioning

confidence: 89%

“…The valacyclovir 1-day treatment regimen of 2 g twice daily was expected to provide a peak acyclovir concentration of approximately 8 g/ml and a concentrationtime profile in excess of the 99% inhibitory concentration of 4.21 g/ml for approximately 5.5 h (ϳ23%) during the first 24-h period (3,17,24). A single-day valacyclovir regimen of 2 g (14,16,21). 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).…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

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confidence: 95%

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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

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: 89%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 95%

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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

102

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“…Oral acyclovir can speed healing (Raborn et a/., 1987). Several doubleblind, placebo-controlled trials have been performed with topical acyclovir.…”

Section: Progress In Herpesvirus Management 199mentioning

confidence: 99%

Progress in the Clinical Management of Herpesvirus Infections

Griffiths

1995

Antivir Chem Chemother

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SummaryAntiviral drug discovery has produced a series of drugs active against herpesviruses in vitro. Several of these are now licensed and/or have been used in clinical practice. This article reviews the mechanisms· of action of acyclovir, ganciclovir, penciclovir, sorivudine and foscarnet, the development of resistance to these drugs and their pharmacokinetic and cellular toxicities. Based upon the natural histories of HSV, VZV and CMV, treatment objectives for each virus are discussed and the performance of each drug matched against these objectives. Overall, it is concluded that the perfect drug for treating herpesviruses does not exist, but that significant progress has been made towards controlling several herpesvirus diseases. It.is suggested that further progress will require not just improved drug discovery programmes, but also an understanding of different pathogeneses and an appreciation by practising physicians that antiviral drugs must be given early in the infectious process to achieve the best results.

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“…The frequency of recurrences of herpes labialis is unpredictable, ranging from rare episodes to more than 12 episodes per year [2]. The mean duration of recurrences is 7-8 days, but individual episodes of up to 15 days are reported, too [3,4]. Although herpes simplex labialis/facialis usually has a self-limited course, the disease can significantly affect quality of life, especially for patients who experience frequent recurrences.…”

Section: Introductionmentioning

confidence: 99%

Penciclovir Cream – Improved Topical Treatment for Herpes simplex Infections

Schmid‐Wendtner

Korting

2004

Skin Pharmacol Physiol

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Human herpesviruses can be found worldwide and cause many viral infections in immunocompetent as well as in immunocompromised patients. Herpes simplex virus (HSV) diseases can be the cause of life-threatening disease, especially in neonates. After initial infection, HSV persists latently in host neurons with the risk of periodical reactivation over a lifetime. The development of acyclovir, a potent and specific nucleoside inhibitor of the herpes DNA polymerase, was a milestone in the history of antiviral drugs in the late 1970s. During the last decades a better understanding of the replication and disease-causing state of HSV types 1 and 2 has been achieved enabling the development of new and potent antiviral compounds. In the mid-1990s, for example, valacyclovir and famciclovir were launched as prodrugs of acyclovir with improved bioavailability. Despite the numerous drugs available for the systemic treatment of HSV infections, the topical application of a cream containing an antiviral agent is still the most convenient method of treating herpes simplex labialis/facialis in the general population. For some time, the topical standard treatment for recurrent HSV infections has been acyclovir cream, despite the fact that the evidence for efficacy in recurrent episodes has been equivocal. Penciclovir, a novel acyclic nucleoside analogue, has demonstrated efficacy against HSV types 1 and 2 and seems to have a pharmacological advantage due to a prolonged half-life of its active form in HSV-infected cells. This review discusses and compares the topical treatment modalities available for HSV infections. As a conclusion, different studies are available that have shown that it is possible to reduce viral replication and hasten lesion resolution with 1% penciclovir treatment beyond the prodromal phase of the HSV infection. Comparing data of topical treatment with acyclovir and penciclovir revealed a superiority for penciclovir cream showing a significant decrease in time to lesion healing, lesion area and pain. While systemic acyclovir or valacyclovir may be valid drugs especially for HSV prophylaxis, 1% penciclovir cream should be preferred as topical treatment since there are good therapeutic results independent of the phase of development of herpetic eruptions.

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Oral acyclovir and herpes labialis: a randomized, double-blind, placebo-controlled study

Cited by 73 publications

References 13 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

Progress in the Clinical Management of Herpesvirus Infections

Penciclovir Cream – Improved Topical Treatment for Herpes simplex Infections

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