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Antimicrobial Agents and Chemotherapy, March 2003, p. 1072-1080, Vol. 47, No. 3
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.3.1072-1080.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

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

Spotswood L. Spruance,1* Terry M. Jones,2 Mark M. Blatter,3 Mauricio Vargas-Cortes,4 Judy Barber,5 Joanne Hill,5 Donna Goldstein,4 and Margaret Schultz4, and Valacyclovir Cold Sore Study Group{dagger}

University of Utah, Salt Lake City, Utah,1 J & S Studies, Inc., Bryan, Texas,2 Primary Physicians Research, Pittsburgh, Pennsylvania,3 GlaxoSmithKline, Research Triangle Park, North Carolina,4 GlaxoSmithKline, Greenford, United Kingdom5

Received 31 July 2002/ Returned for modification 23 September 2002/ Accepted 21 November 2002

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.

* Corresponding author. Mailing address: University of Utah, Division of Infectious Diseases, School of Medicine, Rm. 4B319, 50 North Medical Dr., Salt Lake City, UT 84132. Phone and fax: (801) 581-8804. E-mail: woody.spruance{at}hsc.utah.edu.

{dagger} The members of the Valacyclovir Cold Sore Study Group are S. L. Block, Jr., Kentucky Pediatric Research, Bardstown; M. G. Davis, Rochester Clinical Research, Rochester, N.Y.; B. Furst, California State University, Chico; M. Kutcher, University of North Carolina, Chapel Hill; R. Lapidus, Rocky Mountain Center for Clinical Research, Wheat Ridge, Colo.; L. V. Larsen, Intermountain Clinical Research, Salt Lake City, Utah; M. G. Lassonde, Montréal, Canada; T. C. Marbury, Orlando Clinical Research Center, Orlando, Fla.; J. L. Powers, Radiant Research, Inc., Scottsdale, Ariz.; S. K. Tyring, UTMB Center for Clinical Studies, Nassau Bay, Tex.; et al.

Antimicrobial Agents and Chemotherapy, March 2003, p. 1072-1080, Vol. 47, No. 3
0066-4804/03/$08.00+0     DOI: 10.1128/AAC.47.3.1072-1080.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Opstelten, W., Neven, A. K., Eekhof, J. (2008). Treatment and prevention of herpes labialis. cfp 54: 1683-1687 [Abstract] [Full Text]  
  • Cernik, C., Gallina, K., Brodell, R. T. (2008). The Treatment of Herpes Simplex Infections: An Evidence-Based Review. Arch Intern Med 168: 1137-1144 [Abstract] [Full Text]  
  • MILLER, C. S., CUNNINGHAM, L. L., LINDROTH, J. E., AVDIUSHKO, S. A. (2004). The efficacy of valacyclovir in preventing recurrent herpes simplex virus infections associated with dental procedures. Journal of the American Dental Association 135: 1311-1318 [Abstract] [Full Text]  
  • Spruance, S. L., Hill, J. (2004). Clinical significance of antiviral therapy for episodic treatment of herpes labialis: exploratory analyses of the combined data from two valaciclovir trials. J Antimicrob Chemother 53: 703-707 [Abstract] [Full Text]  
  • Jensen, L. A, Hoehns, J. D, Squires, C. L (2004). Oral Antivirals for the Acute Treatment of Recurrent Herpes Labialis. The Annals of Pharmacotherapy 38: 705-709 [Abstract] [Full Text]  


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