GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Valtrex (valacyclovir HCl) caplets for the suppression of recurrent genital herpes in HIV-infected individuals.
"This approval is significant for the many people who are HIV-infected and also have genital herpes," said Edwin DeJesus, Infectious Disease Consultants, Altamonte Springs, Fla. "These patients now have a safe and effective medication approved for the suppression of genital herpes outbreaks."
Valtrex is the first and only anti-viral approved in the US for suppression of recurrent genital herpes outbreaks in HIV-infected individuals.
More than 900,000 people in the United States are HIV-infected. Of these, as many as 58-81 percent are also co-infected with genital herpes. Genital herpes in HIV-infected individuals can often mean more frequent and severe outbreaks of genital herpes. 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 painful or itchy cluster of blisters, bumps and rashes in the genital area, or on the thighs or buttocks. To help prevent spreading genital herpes to others, sexual contact should be avoided during outbreaks and safer sex practices should be followed, including use of condoms even between outbreaks.
"We are pleased to further expand the use of suppressive therapy with Valtrex to include HIV-infected individuals," said Clarence Young, Vice President, Clinical Development and Medical Affairs, GlaxoSmithKline. "GlaxoSmithKline is a leader in research and treatment for both genital herpes and HIV, and we will continue to provide options for people with these diseases."