PRNewswire - December 17, 2001

Study results from a year long, randomized, open label trial of 80 otherwise healthy adults with a history of four to nine outbreaks of genital herpes per year found that suppressive therapy with 500mg of VALTREX once-a-day for recurrent genital herpes greatly reduced the number of genital herpes outbreaks by nearly 80 percent (78.1%) compared to episodic therapy with 500mg of VALTREX twice a day for five days. The time between outbreaks was substantially different between episodic and suppressive therapy, therefore providing patients on suppressive therapy with significant relief from the disease. The mean number of days between outbreaks was 53 for patients on episodic therapy versus 179.8 for patients on suppressive therapy.

"The findings of this study represent a continued understanding of the different treatment options specifically for patients infected with genital herpes," says lead study author Kenneth H. Fife, M.D., Ph.D., Professor of Medicine, Microbiology & Immunology and Pathology at the Indiana University School of Medicine. "Recurrent outbreaks can sometimes affect both a patient's physical and emotional health, making the reduction in frequency of outbreaks important to those patients."

Both episodic and suppressive antiviral therapies treat genital herpes outbreaks by disrupting the process by which the herpes virus reproduces itself and spreads to other cells in the body. There is no cure for genital herpes and no drug has been proven to prevent the spread of herpes to others. Episodic therapy is used to treat recurrent outbreaks of genital herpes at the first sign of symptoms. Suppressive therapy means taking medication daily to help suppress outbreaks before symptoms ever appear. VALTREX is the only antiviral medication indicated for once daily dosing to suppress recurrent genital herpes outbreaks. In addition, VALTREX is also the only antiviral approved for a three-day course of therapy to treat recurrent episodes of genital herpes. VALTREX is indicated for the initial and recurrent treatment and for suppression of genital herpes outbreaks. The most common side effects with VALTREX are headache, nausea and abdominal pain. VALTREX is intended for adults with normal immune systems. To avoid a potentially serious complication, patients should tell their doctor if their immune system is not normal because of advanced HIV disease, bone marrow or kidney transplant.

BACKGROUND ON DATA:

Eighty otherwise healthy subjects with a history of four to nine recurrences per year participated in this randomized open-label trial. A total of 66 subjects completed the trial, with 32 subjects on episodic therapy and 34 subjects on suppressive therapy. Demographics and prior history of recurrent genital herpes were similar between the two treatment groups. Subjects receiving episodic therapy self-initiated 500 mg of VALTREX twice a day for five days at the first sign of recurrence. Those randomized to suppressive therapy were given 500 mg of VALTREX daily for one full year. Patients maintained daily diaries recording information relating to their herpes outbreaks and were evaluated monthly.

Key findings include:

-- Forty-one percent of those subjects receiving suppressive therapy did not experience an outbreak during the study compared to three percent of those on episodic therapy.

-- The mean number of days between recurrences of genital herpes was 179.8 days for patients on suppressive therapy compared with 53 days between recurrences for those on episodic therapy.

-- During the study, patients on suppressive therapy experienced a mean of 1.6 recurrences of genital herpes outbreaks versus 7.3 recurrences for those on episodic therapy.

ADDITIONAL BACKGROUND INFORMATION:

Genital herpes is a sexually transmitted disease (STD) that affects the genital areas of both men and women. More than 50 million Americans currently have genital herpes (experts in the field currently estimate this figure to be closer to 60 million) and approximately 500,000 new cases of genital herpes are diagnosed each year. Nine out of ten people who have genital herpes are not aware of their condition. While genital herpes is not a life-threatening disease, the virus never leaves the body, making it a lifelong condition that can recur at various times with or without symptoms. Symptoms of genital herpes may include a cluster of blisters, bumps or rashes in the genital area, or on the thighs or buttocks. The virus passes from person to person through sexual contact. Symptoms need not be present to infect another individual.

The approved dose for suppressive therapy with VALTREX is 1000mg once-a-day. An alternative dose of 500mg of VALTREX once-a-day can be considered for patients with nine or fewer recurrences per year. The approved dose for episodic therapy with VALTREX is 500mg twice a day for three days.

This study was funded by GlaxoSmithKline, one of the world's leading research-based pharmaceutical and health care companies, and manufacturer of VALTREX. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

For complete Prescribing Information for VALTREX, please contact Don Canfield at (212) 891-0422. For more information (including the complete Prescribing Information for VALTREX), please visit http://www.VALTREX.com or http://www.herpeshelp.com.

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