A Randomized, Placebo-Controlled Comparison of Oral Valacyclovir and Acyclovir in Immunocompetent Patients With Recurrent Genital Herpes Infections

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Abstract
THE INCIDENCE of genital herpes simplex virus (HSV) infections is rising worldwide.1-5 Acyclovir (Zovirax, Glaxo Wellcome plc, Middlesex, England ) has been widely used over the past decade as an effective and well-tolerated drug for the treatment of these infections.6-8 Studies have shown that acyclovir given at a dose of 200 mg 5 times daily for 5 days reduces the duration of viral shedding, time to healing, and time to cessation of new lesion formation,9-12 and may completely prevent lesions from progressing beyond the macule or papule stage,9 if treatment is initiated within 24 hours of the first signs or symptoms of the recurrent HSV episode. The recommended regimen of acyclovir results in plasma acyclovir concentrations usually well above those needed to inhibit HSV type 1 and HSV type 2 replication,6,13 but proportionately higher concentrations cannot be achieved with increasing oral doses. Because of the low and limited oral bioavailability of acyclovir (approximately 20%14 ), and the possible compliance problems that can occur because of the 5-times-daily administration schedule, investigators have sought a prodrug of acyclovir that can produce high plasma acyclovir concentrations with fewer daily doses.

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