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Infectious Diseases in Obstetrics and Gynecology
Volume 2009, Article ID 105376, 7 pages
http://dx.doi.org/10.1155/2009/105376
Clinical Study

Once Daily Valacyclovir for Reducing Viral Shedding in Subjects Newly Diagnosed with Genital Herpes

1Planned Parenthood of Arkansas and Eastern Oklahoma, Inc., 5780 S. Peoria Ave, Tulsa, OK 74105, USA
2Department of Medicine, School of Medicine, Indiana University, Indianapolis, IN 46202, USA
3Division of Infections Diseases, University of North Carolina, Chapel Hill, NC 27599, USA
4GlaxoSmithKline, Research Triangle Park, NC 27709, USA

Received 26 March 2009; Accepted 17 June 2009

Academic Editor: Jane R. Schwebke

Copyright © 2009 Mark G. Martens et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. Genital herpes (GH) recurrences and viral shedding are more frequent in the first year after initial HSV-2 infection. The objective of this study was to provide the first evaluation of valacyclovir 1 g once daily compared to placebo in reducing viral shedding in subjects newly diagnosed with GH. Methods. 70 subjects were randomized to receive valacyclovir 1 g daily or placebo in a crossover design for 60 days with a 7-day washout period. A daily swab of the genital/anal-rectal area was self-collected for HSV-2 detection by PCR. Subjects attended the clinic for routine study visits and GH recurrence visits. Treatment differences were assessed using a nonparametric crossover analysis. Results. 52 subjects had at least one PCR measurement in both treatment periods and comprised the primary efficacy population. Valacyclovir significantly reduced HSV-2 shedding during all days compared to placebo (mean 2.9% versus 13.5% of all days ( ), a 78% reduction). Valacyclovir significantly reduced subclinical HSV-2 shedding during all days compared to placebo (mean 2.4% versus 11.0% of all days ( ), a 78% reduction). However, 79% of subjects had no GH recurrences while receiving valacyclovir compared to 52% of subjects receiving placebo ( ). Conclusion. In this study, the frequency of total and subclinical HSV-2 shedding was greater than reported in earlier studies involving subjects with a history of symptomatic genital recurrences. Our study is the first to demonstrate a significant reduction in viral shedding with valacyclovir 1 g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection.