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Once-Daily Valacyclovir Hydrochloride for Suppression of Recurrent Genital Herpes

From the State University of New York, Stony Brook, New York; St. John’s Mercy Medical Center, St. Louis, Missouri; and Glaxo Wellcome Inc., Research Triangle Park, North Carolina.

Address reprint requests to: David A. Baker, Stony Brook Health Sciences Center, State University of New York, Stony Brook, NY 11794, E-mail: david.baker{at}sunysb.edu

Objective: To document the frequency of genital herpes recurrences in men and women with histories of recurrent genital herpes during 1 year of continuous, suppressive therapy with valacyclovir hydrochloride (HCl).

Methods: In an open-label clinical trial conducted at 11 centers, 127 subjects (46 women and 81 men) with histories of recurrent genital herpes (at least 6 recurrences per year) were treated with valacyclovir HCl (500 mg once daily), and their clinical status was followed up for 1 year. Genital herpes recurrences were documented in diaries, and quarterly clinic visits were made for evaluating lesion recurrences and drug safety. In cases of recurrence, subjects self-treated with valacyclovir HCl 500 mg twice daily for 5 days, then resumed once-daily treatment.

Results: After the first 3 months of suppressive therapy, 81% of subjects were free of recurrence. Recurrence-free rates remained undiminished during the second, third, and fourth quarters (84%, 84%, and 91%, respectively) and were similar for men and women. Thirty of 46 women (65%) and 56 of 81 men (69%) remained recurrence free during the study and therapy was well tolerated. Adverse events were mild, infrequent, and not considered related to the study drug.

Conclusion: Valacyclovir HCl was highly effective and well tolerated as continuous suppressive therapy in men and women with recurrent genital herpes. Potential benefits of the once-daily regimen of valacyclovir HCl include improved patient compliance

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