• J. Infect. Dis. · Oct 2004

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Valacyclovir and acyclovir for suppression of shedding of herpes simplex virus in the genital tract.

    • Rachna Gupta, Anna Wald, Elizabeth Krantz, Stacy Selke, Terri Warren, Mauricio Vargas-Cortes, Gerri Miller, and Lawrence Corey.
    • Department of Medicine, University of Washington, Seattle, Washington 98122, USA. rachnag@u.washington.edu.
    • J. Infect. Dis. 2004 Oct 15; 190 (8): 1374-81.

    BackgroundValacyclovir exhibits better oral absorption and higher, more prolonged serum concentrations than oral acyclovir. The efficacy of valacyclovir and acyclovir on genital herpes simplex virus (HSV) shedding was assessed in a double-blind, 3-period crossover trial.MethodsSixty-nine immunocompetent participants with genital HSV-2 received oral valacyclovir, acyclovir, and matching placebo in random order for 7-week periods. Participants provided daily genital mucosal swabs for HSV detection by viral culture and polymerase chain reaction (PCR).ResultsHSV was detected at least once in 62 (90%) participants by culture and in 68 (98%) by PCR. During placebo, the total HSV shedding rate was 15.4% of days by culture (PCR, 40.2%); the subclinical shedding rate was 6.6% by culture (PCR, 27.1%). Both antivirals were associated with lower HSV shedding by culture (relative risk [RR], 0.03 [95% confidence interval [CI], 0.01-0.07] for valacyclovir and RR, 0.05 [95% CI, 0.03-0.10] for acyclovir) and PCR (RR, 0.18 [95% CI, 0.12-0.26] for valacyclovir and RR, 0.20 [95% CI, 0.15-0.28] for acyclovir), compared with placebo. No significant differences in frequency and quantity of HSV were detected by PCR between the valacyclovir and acyclovir arms.ConclusionsAlthough the suppression of viral replication is not complete, valacyclovir and acyclovir are highly effective in suppressing the frequency and quantity of genital HSV shedding.Copyright 2004 Infectious Diseases Society of America

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