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New study evaluates Valtrex Caplets for reduction of genital herpes transmission

SAN DIEGO, CA., Sept. 27 -- According to study data presented at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), once-daily suppressive therapy with Valtrex (valacyclovir HCl) caplets reduced transmission of symptomatic genital herpes (a visible outbreak) by 77 percent in healthy heterosexual monogamous couples.

In addition, suppressive therapy with Valtrex reduced the overall acquisition of the virus (determined by a positive blood test and/or laboratory confirmation) by 50 percent. Throughout the study, all couples were provided with condoms and counseled on safer sexual behavior at all study visits.

"This is the first time an anti-viral has been shown to reduce sexual transmission of a sexually transmitted disease and provides another groundbreaking concept in antiviral chemotherapy for this agent," said Larry Corey, M.D., lead study author and professor, Laboratory Medicine and Medicine, University of Washington, and head of the Program in Infectious Diseases, Fred Hutchinson Cancer Research Center.

"In this study, Valtrex, along with condom use and counseling, reduced the rate of transmission significantly in the population studied. While the effect on reducing transmission was not complete, the use of suppressive therapy provides health care providers and patients with genital herpes an important new tool for managing this increasingly prevalent viral sexually transmitted infection."

Experts estimate that genital herpes, which is a contagious, lifelong disease, affects up to 60 million Americans or one in five people over the age of 12. (In 1991, an estimated 45 million Americans were infected with the virus that causes genital herpes.) However, nine out of ten of those are unaware they have genital herpes and may only have experienced a mild initial outbreak without recognizing recurring symptoms of the disease.

Though the disease is most contagious during an outbreak, symptoms do not have to be present to infect someone else. In fact, experts confirm most transmission of genital herpes occurs without symptoms being present, known as asymptomatic viral shedding, and when the infected person is unaware of being infectious.

"GlaxoSmithKline is committed to research into the prevention and treatment of genital herpes," said Clarence Young, M.D., Vice President, Clinical Development and Medical Affairs, GlaxoSmithKline. "GSK supports the CDC recommendations for safer sex practices, including the use of condoms. We are excited by the results of this important study with Valtrex. While Valtrex is not approved for reduction of transmission of genital herpes, we are currently evaluating our options."

Valtrex is currently indicated for the initial and recurrent treatment, and for suppression of genital herpes outbreaks, and for the treatment of cold sores and herpes zoster (shingles). The most common side effects with Valtrex are headache, nausea, vomiting, dizziness and abdominal pain. Valtrex is intended for adults with normal immune systems. To avoid a potentially serious complication, patients should tell their doctors if their immune system is not normal because of advanced HIV disease, bone marrow or kidney transplant.

There is no cure for the herpes virus, and, even with treatment, it may be possible to spread herpes to others.

Source: GlaxoSmithKline

Posted: September 2002