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

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 (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 1 g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection.

• Authors: Mark G Martens, Kenneth H Fife, Peter A Leone, Lynn P Dix, Clare A Brennan
• Journal: Infectious diseases in obstetrics and gynecology (Infect Dis Obstet Gynecol) Vol. 2009 Pg. 105376 ( 2009) ISSN: 1098-0997 [Electronic] Egypt
• PMID: 19680456 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Valine
• Valacyclovir
• Acyclovir

Topics

• Acyclovir (analogs & derivatives, therapeutic use)
• Adolescent
• Adult
• Antiviral Agents (therapeutic use)
• Cross-Over Studies
• Double-Blind Method
• Female
• Herpes Genitalis (drug therapy, virology)
• Herpesvirus 2, Human (physiology)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Valacyclovir
• Valine (analogs & derivatives, therapeutic use)
• Virus Shedding (drug effects)