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FDA Approves Valtrex for Reducing Risk For Sexual Transmission With Suppressive Therapy
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FDA Updates Labeling of Valtrex
source: Aug 29, 2003 FDA Talk Paper
The Food and Drug Administration (FDA) has approved a new indication for Valtrex (valacyclovir hydrochloride) Caplets; Valtrex reduces the risk of heterosexual transmission of genital herpes to susceptible partners with healthy immune systems when used as suppressive therapy in combination with safer sex practices.
Genital herpes is a common sexually transmitted infection caused by herpes simplex viruses (HSV). Many individuals have no or only minimal signs or symptoms from genital HSV infection and may transmit the virus during sexual contact when they show no signs of active infection (i.e. genital lesions).
The following safer sex practices can also lower the chances of passing genital herpes to a partner:
--Use a condom made of latex or polyurethane when you have sexual contact. --Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes.
FDA based its decision to revise the labeling for Valtrex on the results of an international, double-blind, placebo-controlled clinical trial conducted by the manufacturer, GlaxoSmithKline (GSK) of Research Triangle Park, N.C. The study was conducted among about 1500 monogamous, heterosexual couples and lasted eight months. At the beginning of the study, only one member in each couple had evidence of genital herpes. The results of the GSK study showed a 48% reduction in HSV acquisition; individual results may vary based on consistency of safer sex practices.
Valtrex may cause kidney problems in some people. In addition, Valtrex may cause nervous system problems; these include aggressive behavior, unsteady movements, shaky movements, confusion, speech problems, hallucinations, seizures and coma. Kidney and nervous system problems have happened in patients who already have kidney disease and in elderly patients whose kidneys do not work well due to age. Therefore, it is important for patients to tell their healthcare providers if they have kidney problems or other medical conditions before taking Valtrex.
Today’s action follows the recommendation of FDA’s Antiviral Drugs Advisory Committee, which met on May 14, 2003, to discuss GSK’s then-proposed use of Valtrex for reduction of the risk of transmission of genital herpes with the use of suppressive therapy. FDA first approved Valtrex in 1995.
To read report on FDA Hearing and review of study results:
Valtrex For Reducing Transmission of Genital Herpes- FDA Hearing: FDA panel votes 11-0 to recommend approval http://www.natap.org/2003/may/051503_1.htm
CLINICAL TRIALS Herpes Zoster: Two randomized double-blind clinical trials in immunocompetent adults with localized herpes zoster were conducted. VALTREX was compared to placebo in patients less than 50 years of age, and to ZOVIRAX in patients greater than 50 years of age. All patients were treated within 72 hours of appearance of zoster rash. In patients less than 50 years of age, the median time to cessation of new lesion formation was 2 days for those treated with VALTREX compared to 3 days for those treated with placebo. In patients greater than 50 years of age, the median time to cessation of new lesions was 3 days in patients treated with either VALTREX or ZOVIRAX. In patients less than 50 years of age, no difference was found with respect to the duration of pain after healing (post-herpetic neuralgia) between the recipients of VALTREX and placebo. In patients greater than 50 years of age, among the 83% who reported pain after healing (post-herpetic neuralgia), the median duration of pain after healing [95% confidence interval] in days was: 40 [31, 51, 43 [36, 55], and 59 [41, 77] for 7-day VALTREX, 14-day VALTREX, and 7-day ZOVIRAX, respectively.
Genital Herpes Infections: Initial Episode: Six hundred and forty-three immunocompetent adults with first episode genital herpes who presented within 72 hours of symptom onset were randomized in a double-blind trial to receive 10 days of VALTREX 1 gram twice daily (n = 323) or ZOVIRAX 200 mg 5 times a day (n = 320). For both treatment groups: the median time to lesion healing was 9 days, the median time to cessation of pain was 5 days, the median time to cessation of viral shedding was 3 days.
Recurrent Episodes: Three double-blind trials (2 of them placebo-controlled) in immunocompetent adults with recurrent genital herpes were conducted. Patients self-initiated therapy within 24 hours of the first sign or symptom of a recurrent genital herpes episode. In 1 study, patients were randomized to receive 5 days of treatment with either VALTREX 500 mg twice daily (n = 360) or placebo (n = 259). The median time to lesion healing was 4 days in the group receiving VALTREX 500 mg versus 6 days in the placebo group, and the median time to cessation of viral shedding in patients with at least 1 positive culture (42% of the overall study population) was 2 days in the group receiving VALTREX 500 mg versus 4 days in the placebo group. The median time to cessation of pain was 3 days in the group receiving VALTREX 500 mg versus 4 days in the placebo group. Results supporting efficacy were replicated in a second trial.
In a third study, patients were randomized to receive VALTREX 500 mg twice daily for 5 days (n = 398) or VALTREX 500 mg twice daily for 3 days (and matching placebo twice daily for 2 additional days) (n = 402). The median time to lesion healing was about 4.5 days in both treatment groups. The median time to cessation of pain was about 3 days in both treatment groups.
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