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Drug approved for lowering herpes transmission risk: for use in heterosexuals: Valtrex cut transmissions to susceptible partners by 50%-75% in 8-month study.(News)
The Food and Drug Administration has approved valacyclovir for use as suppressive therapy to reduce the risk of heterosexual transmission of genital herpes to susceptible partners.
The approval is limited to otherwise healthy adults with competent immune systems, and suppressive therapy should be used in combination with "safer sex practices," the FDA said in a statement.
Approval was based on the results of a landmark, international trial of more than 1,000 heterosexual, monogamous, immunocompetent couples. The study showed that a daily suppressive dose of 500 mg taken by the infected partner reduced transmission of symptomatic genital herpes (herpes simplex virus type 2) to the uninfected partner by 75% over 8 months. When asymptomatic infections were included, the risk of transmission decreased by 50%, which was still a significant reduction.
"Every doctor providing care for persons with [genital] herpes should be aware of the data, aware of the efficacy, and should make their patients understand it is one option they can employ to help protect their partners," Dr. H. Hunter Handsfield, professor of medicine at the University of Washington, Seattle, said in an interview.
Available since 1995, valacyclovir (Valtrex) was previously approved for the treatment or suppression of genital herpes in otherwise healthy people and suppression of recurrent genital herpes in HIV-infected individuals.
The rationale behind using valacyclovir to reduce transmission rates is that the drug suppresses recurrences and reduces viral shedding, according to GlaxoSmithKline, which markets Valtrex.
Dr. Handsfield was the FDA's invited guest expert at a meeting of the agency's Antiviral Drugs Advisory Committee in May, during which committee members unanimously recommended that valacyclovir be approved for this indication in monogamous, heterosexual couples, the population studied in the trial. (Dr. Handsfield was not an investigator in this trial, but has done research for GlaxoSmithKline and is on the company's speakers' bureau.)
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