High-dose, short-duration, early valacyclovir therapy for episodic treatment of cold sores: Results of two randomized, placebo-controlled, multicenter studies

被引:73
作者
Spruance, SL
Jones, TM
Blatter, MM
Vargas-Cortes, M
Barber, J
Hill, J
Goldstein, D
Schultz, M
机构
[1] Univ Utah, Sch Med, Div Infect Dis, Salt Lake City, UT 84132 USA
[2] J&S Studies Inc, Bryan, TX USA
[3] Primary Phys Res, Pittsburgh, PA USA
[4] GlaxoSmithKline, Res Triangle Pk, NC USA
[5] GlaxoSmithKline, Greenford, Middx, England
关键词
D O I
10.1128/AAC.47.3.1072-1080.2003
中图分类号
Q93 [微生物学];
学科分类号
071005 [微生物学]; 100705 [微生物与生化药学];
摘要
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 Mice 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.
引用
收藏
页码:1072 / 1080
页数:9
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