Effect of valacyclovir on viral shedding in immunocompetent patients with recurrent herpes simplex virus 2 genital herpes: A US-based randomized, double-blind, placebo-controlled clinical trial

Kenneth Fife, Terri J. Warren, R. David Ferrera, Douglas G. Young, Scott E. Justus, Catherine K. Heitman, Scott M. Burroughs

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir to reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes. PATIENTS AND METHODS: From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 3 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-bind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and instructed to take 2 caplets once daily without regard to meals for 30 days. Daily genital and anal or rectal swabs were self-collected during the 30-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay. RESULTS: One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 30 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (P<.001), a 58% reduction in subclinical shedding (P<.001), and a 64% reduction in clinical shedding (P=.01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo. CONCLUSION: This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy tnat significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.

Original languageEnglish
Pages (from-to)1321-1327
Number of pages7
JournalMayo Clinic Proceedings
Volume81
Issue number10
StatePublished - 2006

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valacyclovir
Virus Shedding
Herpes Genitalis
Human Herpesvirus 2
Controlled Clinical Trials
Placebos
Poisons

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  • Medicine(all)

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Effect of valacyclovir on viral shedding in immunocompetent patients with recurrent herpes simplex virus 2 genital herpes : A US-based randomized, double-blind, placebo-controlled clinical trial. / Fife, Kenneth; Warren, Terri J.; Ferrera, R. David; Young, Douglas G.; Justus, Scott E.; Heitman, Catherine K.; Burroughs, Scott M.

In: Mayo Clinic Proceedings, Vol. 81, No. 10, 2006, p. 1321-1327.

Research output: Contribution to journalArticle

Fife, Kenneth ; Warren, Terri J. ; Ferrera, R. David ; Young, Douglas G. ; Justus, Scott E. ; Heitman, Catherine K. ; Burroughs, Scott M. / Effect of valacyclovir on viral shedding in immunocompetent patients with recurrent herpes simplex virus 2 genital herpes : A US-based randomized, double-blind, placebo-controlled clinical trial. In: Mayo Clinic Proceedings. 2006 ; Vol. 81, No. 10. pp. 1321-1327.
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abstract = "OBJECTIVE: To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir to reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes. PATIENTS AND METHODS: From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 3 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-bind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and instructed to take 2 caplets once daily without regard to meals for 30 days. Daily genital and anal or rectal swabs were self-collected during the 30-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay. RESULTS: One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93{\%}], 94 valacyclovir [86{\%}]), and 18 prematurely withdrew (3 placebo [7{\%}], 15 valacyclovir [14{\%}]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 30 days compared with placebo. In the intent-to-treat population, a 71{\%} reduction in total shedding (P<.001), a 58{\%} reduction in subclinical shedding (P<.001), and a 64{\%} reduction in clinical shedding (P=.01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo. CONCLUSION: This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy tnat significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.",
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T2 - A US-based randomized, double-blind, placebo-controlled clinical trial

AU - Fife, Kenneth

AU - Warren, Terri J.

AU - Ferrera, R. David

AU - Young, Douglas G.

AU - Justus, Scott E.

AU - Heitman, Catherine K.

AU - Burroughs, Scott M.

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AB - OBJECTIVE: To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir to reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes. PATIENTS AND METHODS: From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 3 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-bind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and instructed to take 2 caplets once daily without regard to meals for 30 days. Daily genital and anal or rectal swabs were self-collected during the 30-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay. RESULTS: One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 30 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (P<.001), a 58% reduction in subclinical shedding (P<.001), and a 64% reduction in clinical shedding (P=.01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo. CONCLUSION: This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy tnat significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.

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