The placebo-controlled study will enroll 1,500 couples with one partner who has tested positive for genital herpes and one who has tested negative. The partner with genital herpes in each couple will be randomized to receive a once-daily treatment with Valtrex (500 mg) or placebo.
Valtrex is currently approved for use for both treatment and suppression of outbreaks of genital herpes. It is believed that the mechanism of action of Valtrex has an impact on the replication of the virus and when used as suppressive therapy may have an impact on the transmission of the disease. To date, there are no clinical data from research studies establishing that anti-herpetic drugs can prevent transmission of the virus that causes genital herpes.
Experts suggest the dramatic increase in the prevalence of genital herpes is largely due to misperceptions about how the disease is transmitted.
"Unfortunately, people think genital herpes can only be spread when there are active lesions. In fact, the virus can be transmitted from an infected individual at any time, regardless of whether or not there are any visible signs of an outbreak," says Lawrence Corey, M.D., professor of medicine at the University of Washington and principal investigator for the study.
"This misunderstanding about the transmission of genital herpes is a large contributor to the increasing population infected with HSV-2."
Reducing the risk of transmission of genital herpes is important, not only from a physical perspective, but from an emotional one as well. Several surveys have revealed that one of the major worries of persons with this life-long infection is that they will transmit the virus to another.
The study was announced last fall following the publication of results from a Centers for Disease Control and Prevention (CDC) study in the New England Journal of Medicine, which concluded that the prevalence of HSV-2 infection - the most common cause of genital herpes - has increased by 30 percent since the late 1970s and is now detectable in roughly one in five persons 12 years of age or older nationwide.
Couples enrolled in the study must be over the age of 18, be in a monogamous sexual relationship and in general good health. They must also be willing to observe safer sex practices and behaviors. Couples will be tested for the presence of antibodies to the virus that causes genital herpes at the time the they are screened for participation in the study. Both participants will be followed for 8 months. The susceptible partners will be monitored for clinical and laboratory evidence of acquisition of genital herpes.
In clinical trials, Valtrex was generally well-tolerated with the most commonly reported adverse events consisting of headache, nausea and abdominal pain. The efficacy of Valtrex has not been established in immunocompromised patients.
Signs and symptoms of genital herpes outbreaks may include swelling, pain, itching and burning in the genital area, followed by redness and blisters or sores that eventually crust over and heal. Fever, chills, muscle aches, tiredness and headaches can also occur.
Although genital herpes is not a life-threatening disease, some experts believe it to be a contributing factor in the spread of other potentially serious sexually transmitted diseases and may even facilitate the transmission of the human immunodeficiency virus (HIV).
Patients are currently being recruited for the clinical trial. To find out more, call 1-888-842-4721.
Valtrex is the most frequently used branded therapy for treatment of genital herpes and received clearance from the U.S. Food and Drug Administration (FDA) in September 1997 for use in suppressing outbreaks of the disease.
Valtrex was developed and is marketed by Glaxo Wellcome Inc., headquartered in Research Triangle Park, N.C. A subsidiary of London-based Glaxo Wellcome p.c., the Company is committed to fighting disease by bringing innovative medicines and services to patients and to the healthcare providers who serve them.
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