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An international, randomized, double-blind, placebo-controlled, study of valacyclovir for the suppression of herpes simplex virus type 2 genital herpes in newly diagnosed patients.

AbstractBACKGROUND:
Antiviral suppressive therapy of genital herpes is often initiated based on the established pattern of recurrences in an individual. Because most persons with first episode herpes simplex virus type 2 (HSV-2) infection experience recurrences and because viral shedding occurs frequently in the first year after infection, we examined the strategy of initiating suppressive therapy shortly after diagnosis of genital HSV-2 infection.
SUBJECTS AND METHODS:
From June 16, 2004 to July 26, 2006, 384 subjects from 74 sites in the United States, Canada, Argentina, Brazil, and Chile who were newly diagnosed with a first recognized episode of genital herpes at the time of the screening visit or within 3 months before the screening visit were randomized (2:1) to receive valacyclovir 1 g once daily or placebo for 24 weeks. Subjects were instructed to return to clinic during suspected genital herpes outbreaks for clinician confirmation of recurrences.
RESULTS:
Valacyclovir significantly prolonged the time to first recurrence of HSV-2 genital herpes in newly diagnosed subjects compared with placebo, with approximately 43% of subjects on placebo and 71% of subjects on valacyclovir recurrence-free at 24 weeks (P <0.001). Valacyclovir significantly reduced the mean number of genital HSV-2 recurrences per month occurring during the 24-week study period (0.11 for valacyclovir, 0.48 for placebo, P <0.001). Adverse events were comparable in the valacyclovir and placebo arms.
CONCLUSION:
Valacyclovir 1 g once daily administered for 24 weeks was well-tolerated and effective in suppressing genital herpes recurrences in immunocompetent newly diagnosed persons without an established recurrence pattern.
AuthorsKenneth H Fife, Terri J Warren, Scott E Justus, Catherine K Heitman, HS2100275 STUDY TEAM
JournalSexually transmitted diseases (Sex Transm Dis) Vol. 35 Issue 7 Pg. 668-73 (Jul 2008) ISSN: 0148-5717 [Print] United States
PMID18461016 (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 (administration & dosage, analogs & derivatives, therapeutic use)
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Antiviral Agents (administration & dosage, therapeutic use)
  • Brazil
  • Canada
  • Chile
  • Double-Blind Method
  • Female
  • Herpes Genitalis (drug therapy, pathology)
  • Herpesvirus 2, Human
  • Humans
  • Male
  • Middle Aged
  • Recurrence
  • Treatment Outcome
  • United States
  • Valacyclovir
  • Valine (administration & dosage, analogs & derivatives, therapeutic use)

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