A Large-Scale, Placebo-Controlled, Dose-Ranging Trial of Peroral Valaciclovir for Episodic Treatment of Recurrent Herpes Genitalis

doi:10.1001/archinte.1996.00440140169018

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Vol. 156 No. 15, 12 AUGUST 1996

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A Large-Scale, Placebo-Controlled, Dose-Ranging Trial of Peroral Valaciclovir for Episodic Treatment of Recurrent Herpes Genitalis

Spotswood L. Spruance, MD; Stephen K. Tyring, MD; Barry DeGregorio, MD; Cheryl Miller, PharmD; Karl Beutner, MD

Arch Intern Med. 1996;156(15):1729-1735.

Abstract

Background
Valaciclovir, the 1-valyl ester of acyclovir, has provided aperoral acyclovir bioavailability 3 to 5 times that of acycloviritself and is rapidly and completely converted to acyclovirby the liver. Accordingly, valaciclovir has the same antiviralactivity as acyclovir, but the potential for enhanced clinicalactivity and/or less frequent administration because of itssuperior pharmacokinetics.

Methods
We conducted a double-blind, placebo-controlled, patient-initiatedclinical trial of peroral valaciclovir, 500 or 1000 mg, or matchingplacebo tablets twice daily for 5 days for the acute treatmentof 1 episode of recurrent herpes genitalis among 987 otherwisehealthy volunteers.

Results
Both doses of valaciclovir were equally effective. Patientsreceiving the lower dose of valaciclovir experienced a medianepisode length of 4.0 days compared with 5.9 days for thosereceiving placebo treatment (hazard ratio, 1.9; 95% confidenceinterval [CI], 1.6-2.3). Valaciclovir therapy increased theproportion of patients in whom the development of vesicularand ulcer-ative lesions was prevented in comparison with placebotreatment: 31% vs 21% (relative risk, 1.5; 95% CI, 1.1-1.9).Valaciclovir therapy accelerated the resolution of pain (hazardratio, 1.8; 95% CI, 1.5-2.1) and the time to cessation of viralshedding (hazard ratio, 2.9; 95% CI, 2.1-3.9). Adverse reactionsamong the valaciclovir groups were comparable with those ofthe placebo group.

Conclusions
Valaciclovir therapy provided a clinically significant benefitto patients that included shortening of the duration of lesions,the duration of pain or discomfort, and the duration of virusshedding. In addition, this study, to our knowledge, providesthe first convincing demonstration that antiviral therapy canprevent lesion development. These results should prompt a reconsiderationof the role that episodic treatment plays in the managementof recurrent herpes genitalis.

Arch Intern Med. 1996;156:1729-1735

Author Affiliations

the Valaciclovir HSV Study Group

From the Salt Lake City County Health Department and the University of Utah, Salt Lake City (Dr Spruance); University of Texas Medical Branch, Galveston (Dr Tyring); Oregon Health Sciences University, Portland (Dr DeGregorio); Deaconess Family Medicine Research Center, St Louis, Mo (Dr Miller); and the University of California at San Francisco (Dr Beutner).

Footnotes

A complete list of the members of the Valaciclovir HSV StudyGroup appears on page 1734.

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