GlaxoSmithKline Announces Breakthrough in Reducing Genital Herpes Transmission with Valtrex

Strategic Insights -

GlaxoSmithKline has announced the publication of results from a clinical trial evaluating Valtrex, an oral antiviral, in the reduction of transmission of genital herpes. The study, published in the New England Journal of Medicine, showed that Valtrex significantly reduced the risk of transmitting herpes infection to a heterosexual partner by 75 percent when used in combination with safer sex practices. This breakthrough has led to the approval of a new label indication for Valtrex in the reduction of transmission of genital herpes in the USA, Australia, and Finland.

Key Takeaways:

  • The clinical trial involved 1,484 healthy, heterosexual, monogamous couples in 21 countries, with the primary endpoint being the reduction in risk of transmission of symptomatic genital herpes to an uninfected partner.
  • 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).
  • Valtrex also 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).
  • The most commonly reported side effects in the study were headache (VALTREX 29%, placebo 26%), nasopharyngitis (VALTREX 16%, placebo 15%), and upper respiratory infection (VALTREX 9%, placebo 10%).
  • The effect of Valtrex on transmission of genital herpes has not been established in immunocompromised individuals or same-sex couples.
  • Larry Corey, M.D., lead study investigator, commented on the significance of this breakthrough: "This is the first demonstration that an antiviral medication can reduce the transmission of a sexually transmitted chronic viral infection."
  • Symptoms of genital herpes can include painful or itchy clusters of blisters, bumps, and rashes in the genital area, or on the thighs or buttocks.
  • The disease is most contagious during an outbreak, but it can also be contagious between outbreaks when no signs and symptoms are present.

Statistics:

  • 45 million Americans were estimated to be infected with the virus that causes genital herpes in 1991 (1 in 5).
  • Up to 60 million Americans have the virus that causes genital herpes.
  • The CDC estimates that approximately 1 million people are infected each year.
  • 9 out of 10 people infected with genital herpes are unaware they have the disease and may only experience a mild initial outbreak without recognizing recurring symptoms.

Sources:

  • GlaxoSmithKline press release, January 1
  • New England Journal of Medicine, January 1 edition
  • FDA approval of Valtrex for suppressive therapy in otherwise healthy adults with genital herpes, August 2003
  • CDC estimates of genital herpes infection in the US
  • Valtrex product information, http://www.valtrex.com/