Generic Valacyclovir HCl (Valtrex® Caplets, GlaxoSmithKline) has been approved to reduce the risk of heterosexual transmission of genital herpes to susceptible partners with healthy immune systems when used as suppressive therapy in combination with safer sex practices. The drug was first approved for the treatment of genital herpes in 1995.
Many individuals have no or only minimal signs or symptoms and may transmit the virus during sexual contact when they show no signs of active infection, such as genital lesions.
The FDA revised the labeling for Canadian Valtrex® on the basis of an international, double-blind, placebo-controlled eight-month clinical trial involving approximately 1,500 monogamous, heterosexual couples. At the beginning of the study, only one member in each couple had evidence of genital herpes. The results showed a 48% reduction in herpes simplex virus acquisition, although individual results may have varied on the basis of safer sex practices.
The medication has caused kidney and nervous system problems (e.g., aggressive behavior, unsteady or shaky movements, confusion, speech problems, hallucinations, seizures, and coma) in some patients with pre-existing renal disease and in elderly patients with impaired renal function. Patients should inform their health care providers if they have had kidney problems or other medical conditions before taking Valtrex®.