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Results of pivotal study for GlaxoSmithKline's Valtrex published in New England Journal of Medicine

Research Triangle Park, N.C., January 1, 2004 GlaxoSmithKline today announced the publication of results from a clinical trial evaluating VALTREX (valacyclovir HCl), an oral antiviral, in the reduction of transmission of genital herpes, in the Jan. 1 edition of the New England Journal of Medicine1. VALTREX significantly reduced the risk of transmitting herpes infection to a heterosexual partner as compared to placebo. Results from this trial have been used to support a new label indication for VALTREX in the reduction in risk of transmission of genital herpes when used in combination with safer sex practices. This new indication has been approved in the USA, Australia and Finland.

The transmission study with VALTREX published in the latest edition of NEJM was a randomized, double-blind, placebo-controlled trial involving 1,484 healthy, heterosexual, monogamous couples in 21 countries. The primary endpoint of the study was to evaluate the reduction in risk of transmission of symptomatic genital herpes (signs or symptoms of GH confirmed with a lab test) to an uninfected partner with use of suppressive therapy with VALTREX. The study showed that once-daily suppressive therapy with VALTREX 500 mg caplets reduced the risk of transmission of symptomatic genital herpes by 75 percent versus placebo (0.5 percent vs 2.2 percent). In addition, suppressive therapy with VALTREX reduced the risk of overall acquisition of the virus (with or without symptoms confirmed by a lab test) by 48 percent versus placebo (1.9 percent vs. 3.6 percent). In addition, VALTREX significantly reduced the number of recurrences in the infected partner versus placebo, consistent with previous studies.

Throughout the eight-month study, all couples were counselled on safer sex practices at all study visits. The principles of safer sex practices were (1) to avoid sexual contact when the infected partner had any symptoms of genital herpes and (2) consistent and correct use of condo
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Contact: Mary Faye Dark, GlaxoSmithKline
919-483-2839
Hill and Knowlton
1-Jan-2004


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