Abstract | BACKGROUND:
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.
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Authors | Kenneth H Fife, Terri J Warren, Scott E Justus, Catherine K Heitman, HS2100275 STUDY TEAM |
Journal | Sexually transmitted diseases
(Sex Transm Dis)
Vol. 35
Issue 7
Pg. 668-73
(Jul 2008)
ISSN: 0148-5717 [Print] United States |
PMID | 18461016
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiviral Agents
- Valine
- Valacyclovir
- Acyclovir
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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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