FDA Approves Valtrex for Reducing Risk For Sexual Transmission With Suppressive Therapy 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. Cervico-vaginal lavage and blood samples were collected at 6m, 12m and 24m for quantification of genital and plasma HIV-1 RNA, and genital HSV DNA. It has been shown that plasma HIV-1 viral loads increase by a median of 3.4-fold during outbreaks of genital herpes and that this level is sustained 30–45 days after the appearance of lesions [2, 3]. A total of 1,479 patients with documented HSV infection were selected for the study. 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. 22/191 (11.5%); OR=0.80, 95%CI:0.42-1.51], genital HIV or HSV viral loads or plasma HIV-1 RNA load. We performed a study to investigate the link between plasma HIV-1 viral loads and outbreaks of genital herpes in patients receiving HAART.
Treatment continued for one year, with patients returning to the clinic monthly. At the beginning of the study, only one member in each couple had evidence of genital herpes. The most frequent cause of genital ulcer disease is herpes simplex virus type 2 (HSV-2) . Plasma acyclovir levels were determined at three, six, nine and 12 months. Patients kept diaries throughout the study to monitor adverse effects, clinical recurrences and use of other medications. 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. Two trials of acyclovir 400mg b.i.d have shown less effect, one finding no reduction in cervico-vaginal HIV-1 RNA detection  and another a reduction in frequency of cervico-vaginal HIV-1 RNA detection and plasma HIV-1 RNA load but no effect on genital HIV-1 load among those shedding .
Five percent of patients reported adverse experiences as a reason for discontinuing the study. The proportions of recurrence-free patients at one year were 50 percent in the group taking 250 mg of valaciclovir twice daily; 48 percent in the group taking 1 g of valaciclovir once daily; 49 percent in the group taking 400 mg of acyclovir twice daily; and 40 percent in the group taking 500 mg of valaciclovir once daily. 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. Trial details have been published previously . Three regimens, valaciclovir at 250 mg twice daily, valaciclovir at 1 g daily and acyclovir at 400 mg twice daily, reduced the recurrence rate by 78 to 79 percent. Valaciclovir in a dosage of 500 mg once daily was associated with a reduction of 71 percent. 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 this paper we report the effects on genital and plasma HIV-1 RNA among the HIV-positive participants. After an analysis of subgroups, the authors concluded that valaciclovir, in a dosage of 500 mg once daily, effectively treated patients with a history of up to 10 HSV recurrences per year. In patients with a history of 10 or more recurrences per year, the most effective daily regimens were valaciclovir in a dosage of 1 g daily or 250 mg twice daily, and acyclovir in a dosage of 400 mg twice daily.