Once-daily valacyclovir hydrochloride for suppression of recurrent genitalherpes

Objective: To document the frequency of genital herpes recurrences in men a nd women with histories of recurrent genital herpes during 1 year of contin uous, suppressive therapy with valacyclovir hydrochloride (HCl). Methods: In an open-label clinical trial conducted at 11 centers, 127 subje cts (46 women and 81 men) with histories of recurrent genital herpes (at le ast 6 recurrences per year) were treated with valacyclovir HCl (500 mg once daily), and their clinical status was followed up for 1 year. Genital herp es recurrences were documented in diaries, and quarterly clinic visits were made for evaluating lesion recurrences and drug safety. In cases of recurr ence, 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 w ere free of recurrence. Recurrence-free rates remained undiminished during the second, third, and fourth quarters (84%, 84%, and 91%, respectively) an d 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 toler ated. Adverse events were mild, infrequent, and not considered related to t he study drug. Conclusion: Valacyclovir HCl was highly effective and well tolerated as con tinuous suppressive therapy in men and women with recurrent genital herpes. Potential benefits of the once-daily regimen of valacyclovir HCl include i mproved patient compliance. (C) 1999 by The American College of Obstetricia ns and Gynecologists.