VALACICLOVIR VERSUS ACYCLOVIR IN PATIENT INITIATED TREATMENT OF RECURRENT GENITAL HERPES - A RANDOMIZED, DOUBLE-BLIND CLINICAL-TRIAL

Objective: To compare the efficacy and safety of twice daily valaciclo vir with five times daily aciclovir in the treatment of an episode of recurrent genital herpes simplex virus (HSV) infection in immunocompet ent individuals. Methods: 739 patients with a history of recurrent gen ital HSV infection received either oral valaciclovir (500 mg twice dai ly) or aciclovir (200 mg five times daily) for 5 days for treatment of their next recurrent episode in a controlled, randomised, double blin d trial. Patients self initiated therapy at the first signs and/or sym ptoms of the HSV recurrence, then were assessed in clinic on five occa sions over 7 days, and twice weekly thereafter until lesions had heale d. Safety was evaluated through adverse experience reports and haemato logy and biochemistry monitoring. Results: No significant differences were detected between valaciclovir and aciclovir for the primary endpo int, the duration of all signs and symptoms which included lesion heal ing and pain/discomfort. The hazard ratio [95% confidence interval] fo r valaciclovir v aciclovir was 0.93 [0.79, 1.08]. Lesion healing time was similar in each treatment group (hazard ratio valaciclovir v acicl ovir 0.96 [0.80, 1.14]). The odds ratio of valaciclovir v aciclovir in preventing the development of vesicular/ulcerative lesions was 1.08 [ 0.82, 1.42]. Percentages of patients in whom all HSV cultures were neg ative were similar in the valaciclovir and aciclovir groups at 59% and 54% respectively; for patients having equal to or more than one posit ive culture result after treatment initiation, cessation of virus shed ding was similarly rapid for the two treatments (hazard ratio 0.98 [0. 75, 1.27]). The safety profiles of valaciclovir and aciclovir were com parable with adverse experiences being infrequent and generally mild. Conclusion: This study has demonstrated that valaciclovir 500 mg twice daily is equivalent in efficacy to aciclovir 200 mg five times daily as episodic treatment of recurrent genital HSV infection. Valaciclovir maintains the established efficacy and safety of aciclovir but offers a much more convenient twice daily dosing regimen.