FDA Approves Valtrex Caplets for Suppression of Recurrent Genital Herpes In HIV-Infected Persons

RESEARCH TRIANGLE PARK, N.C. -- GlaxoSmithKline announced today 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, MD, of Infectious Disease Consultants in 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 United States 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 percent to 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, MD, vice president of clinical development and medical affairs for 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."

The randomized double-blind, placebo-controlled study evaluated 293 HIV-seropositive patients on anti-retroviral therapy for at least two months prior to randomization, over a six-month study period. All patients had a history of recurrent genital herpes, in addition to HIV infection. 194 patients were randomized to Valtrex and 99 to placebo. Patients received either Valtrex 500 mg twice daily or placebo. The primary endpoint was the proportion of patients free of genital herpes recurrences for the duration of the study. After six months, the proportion of patients recurrence-free was 65 percent of those receiving Valtrex 500 mg twice daily, compared with only 26 percent of those receiving placebo. Median time to first recurrence was greater than 180 days for patients receiving Valtrex compared with 59 days for those patients receiving placebo. The most common adverse events were headache, fatigue and rash.

Valtrex is also indicated for the initial and recurrent treatment and for suppression of genital herpes outbreaks in immunocompetent individuals. In these individuals, the most common side effects with Valtrex are headache, nausea and abdominal pain. No data are available on the efficacy of treatment with Valtrex of more than one year's duration for suppressive therapy or started more than 24 hours after the onset of signs and symptoms for episodic therapy. Valtrex is intended for suppression of genital herpes in adults with normal immune systems or in HIV-infected adults with CD4+ counts >100cells/uL. The safety and efficacy of Valtrex in HIV-infected adults with CD4+ counts < 100cells/uL have not been established. The efficacy of Valtrex for the episodic treatment of genital herpes in HIV-infected adults has not been established. The safety and efficacy of treatment with Valtrex beyond six months in people with HIV infection have not been established. To avoid a potentially serious complication, patients should tell their doctor if their immune system is not normal because of advanced HIV disease, or bone marrow or kidney transplant. There is no cure for herpes and even with treatment it is possible to spread it to others. No antiviral has been proven to reduce the transmission of herpes.

Source: GlaxoSmithKline