Once daily valacyclovir for reducing viral shedding in subjects newly diagnosed with genital herpes

Mark G. Martens, Kenneth Fife, Peter A. Leone, Lynn P. Dix, Clare A. Brennan

Research output: Contribution to journalArticle

8 Citations (Scopus)

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 1g once daily compared to placebo in reducing viral shedding in subjects newly diagnosed with GH. Methods. 70 subjects were randomized to receive valacyclovir 1g 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 (P <.01), 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 (P <.01), a 78 reduction). However, 79 of subjects had no GH recurrences while receiving valacyclovir compared to 52 of subjects receiving placebo (P <.01). 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 1g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection. infection.

Original languageEnglish
Article number105376
JournalInfectious Diseases in Obstetrics and Gynecology
Volume2009
DOIs
StatePublished - 2009

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valacyclovir
Virus Shedding
Herpes Genitalis
Human Herpesvirus 2
Placebos
Recurrence
Infection
Polymerase Chain Reaction
Cross-Over Studies
Population

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Infectious Diseases
  • Dermatology

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Once daily valacyclovir for reducing viral shedding in subjects newly diagnosed with genital herpes. / Martens, Mark G.; Fife, Kenneth; Leone, Peter A.; Dix, Lynn P.; Brennan, Clare A.

In: Infectious Diseases in Obstetrics and Gynecology, Vol. 2009, 105376, 2009.

Research output: Contribution to journalArticle

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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 1g once daily compared to placebo in reducing viral shedding in subjects newly diagnosed with GH. Methods. 70 subjects were randomized to receive valacyclovir 1g 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 (P <.01), 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 (P <.01), a 78 reduction). However, 79 of subjects had no GH recurrences while receiving valacyclovir compared to 52 of subjects receiving placebo (P <.01). 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 1g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection. infection.",
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