Suppressive therapy with valacyclovir in early genital herpes: a pilot study of clinical efficacy and herpes-related quality of life.

BACKGROUND: Suppressive therapy has not been studied during the first year after acquisition of genital herpes, the time of maximum frequency of reactivation, potential for transmission, and impact on quality of life.

OBJECTIVE: The objective of this study was to evaluate the effectiveness of suppressive therapy with valacyclovir initiated within 3 months of infection.

STUDY DESIGN: The authors conducted a double-blind, randomized, controlled trial of 1.0 g valacyclovir daily versus placebo for 6 months in 119 patients.

RESULTS: Herpes simplex virus (HSV) type 2 and HSV-1 were documented in 75 and 22 patients, respectively. In intention-to-treat analysis, annualized rates of symptomatic recurrences for valacyclovir and placebo, respectively, were 1.7 +/- 2.7 (mean +/- standard deviation) and 3.4 +/- 4.0 outbreaks per year (P = 0.012). Time to first recurrence was 80 +/- 47 days for valacyclovir and 54 +/- 49 days for placebo (P = 0.001). The differences in favor of valacyclovir were greatest in patients with confirmed HSV-2 infection. The Recurrent Genital Herpes Quality of Life score in HSV-2 infected patients rose 11.9 +/- 11.1 points for valacyclovir and 5.9 +/- 9.1 points for placebo (P = 0.040).

CONCLUSIONS: Early suppressive therapy with valacyclovir reduces symptomatic recurrent outbreaks, especially in patients with HSV-2 infection. Valacyclovir therapy was associated with improved herpes-related quality of life.