FDA panel backs valtrex to cut HSV-2 transmission: transmission down 75% in partners. (Monogamous, Heterosexual Couples).

GAITHERSBURG, MD. -- A federal advisory panel has recommended that suppressive therapy with valacyclovir be approved for reducing the risk of genital herpes transmission from infected to uninfected sexual partners.

The Food and Drug Administration's Antiviral Drugs Advisory Committee voted 13-0 to support use of the drug for this indication in monogamous, heterosexual couples. The FDA usually follows the recommendations of its advisory panels, which are not binding.

The panel based its decision on a landmark study that found sup pressive treatment of infected partners over an 8-month period reduced the transmission of symptomatic genital herpes to uninfected partners by 75%. Study participants were heterosexual, monogamous, immunocompetent couples.

Several panel members said the approval should extend to both heterosexual and homosexual couples; other panelists disagreed, citing a lack of data to guide treatment in populations other than the one enrolled in the study.

Panelists also cautioned that the results should not be applied to immunocompromised individuals, who may have higher viral burdens, but they added that this approach should be studied in this population.

The pediatrician on the panel, Dr. Janet Englund, said that in adolescents suppressive therapy would be an "important adjunct" to condom use in reducing transmission.

But long-term safety and efficacy data on this approach are needed in this age group, added Dr. Englund of Children's Hospital and Regional Medical Center, Seattle.