An extensive clinical trial program combined with 5 years’ postmarketing experience with valacyclovir provides evidence of favorable safety and efficacy in herpes simplex virus (HSV) management. Valacyclovir enhances acyclovir bioavailability compared with orally administered acyclovir. Long-term use of acyclovir for up to 10 years for HSV suppression is effective and well tolerated. Acyclovir is also approved for use in children, is available in some countries over the counter in cream formulation for herpes labialis, and has been monitored in over 1000 pregnancies. Safety monitoring data from clinical trials of valacyclovir, involving over 3000 immunocompetent and immunocompromised persons receiving long-term therapy for HSV suppression, were analyzed. Safety profiles of valacyclovir (⩽1000 mg/day), acyclovir (800 mg/day), and placebo were similar. Extensive sensitivity monitoring of HSV isolates confirmed a very low rate of acyclovir resistance among immunocompetent subjects ( Five years after the licensing of valacyclovir and two decades after the introduction of acyclovir, a wealth of data has been generated on the clinical utility of this selective antiherpes agent and its prodrug. Sexual transmission of herpes simplex virus type 2 (HSV-2) has been demonstrated from both symptomatic and asymptomatic reactivations in the infected partner. Daily antiviral therapy has been shown to decrease the frequency and amount of genital HSV shedding. Corey and colleagues tested daily valacyclovir for efficacy in preventing sexual transmission of HSV-2 from infected persons to their uninfected partners. The study enrolled monogamous, immunocompetent, heterosexual couples in which only one partner was infected with HSV-2, as demonstrated by Western blot analysis of anti–HSV-2 serum antibodies. Of the initial 4,034 couples screened, 1,385 asymptomatic partners already had serologic evidence of HSV-2 infection and were ineligible, and 799 of the source partners were symptomatic but had negative HSV-2 serology. After informed consent, 352 couples declined to participate, and 14 persons declined to take the study medicines, leaving 1,484 couples (37 percent) available for randomization. The infected source partner of each enrolled couple was randomized to receive valacyclovir in a dosage of 500 mg or placebo taken once daily for eight months. Valacyclovir pills Tamoxifen uterus Is azithromycin good for uti For people with a history of 9 or fewer recurrences per year, the recommended dosage of valacyclovir is 500 mg orally once daily. This dose helps to reduce the. Original Article from The New England Journal of Medicine — Once-Daily Valacyclovir to Reduce the Risk of Transmission of Genital Herpes. Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7. Valacyclovir belongs to the class of medications known as antivirals. It is used to treat a viral infection affecting the skin known as shingles (herpes zoster). It is also used to treat cold sores, and to treat and prevent recurrences of genital herpes. It works by interfering with the way the virus reproduces. Valacyclovir works by stopping the virus from multiplying and spreading to nearby healthy cells. It does not cure shingles, cold sores, or genital herpes, but it does help the sores to heal more quickly, and it relieves pain and discomfort. When used to prevent recurrences of herpes, it also reduces the risk of transmission (spreading) of the infection to others. Yesterday May 14 at the irrepressible Holiday Inn in historic (3 strip store malls & a Holiday Inn) Gaithersburg, Maryland the FDA Anitiviral Drug Advisory Committee met for the second time in two days, this time to consider approval of Glaxo Smith Kline's Valtrex (aka Valcyclovir) for use "to reduce the risk of transmission of genital herpes with the use of suppressive therapy and safer sex practices at the dose of 500 mg once daily". The Committee voted 11-0 unanimously to recommend approval to the FDA. GSK conducted an 8 month international study for this approval and the study showed that using 500 mg of Valtrex once daily resulted in a 75% reduction in transmission of symptomatic genital herpes infection, and also showed a 48% reduction in the acquisition asymptomatic acquisition of herpes-2 documented by HSV-2 seroconversion during the study. 4 of 743 (0.5%) study participants who received Valcyclovir (Valtrex) developed symptomatic HSV-2 acquisition compared to 16 of 741 (2.2%) study participants who received placebo in the study (p-value: 0.007). Acquisition of asymptomatic HSV-2 occurred in 14 of 743 (1.9%) persons receiving Valtrex 500 mg once daily compared to 27 of 741 (3.6%) persons receiving placebo who acquired asymptomatic HSV-2 (p-value: 0.038). Men were less likely in the study to develop symptomatic genital herpes: 4.1% of females receiving placebo vs 1.2% of men; 0.8% of females receiving Valtrex vs 0.4% of men receiving Valtrex. Having HSV-1 may provide a protective effect from developing symptomatic genital herpes. For study participants receiving placebo having HSV-1 did not reduce the risk for transmission, 2.2% of persons who were HSV-1 negative vs 2.1% of persons who were HSV-1 positive developed symptomatic genital herpes. But for persons receiving Valtrex 0.9% of persons who were HSV-1 negative developed symptomatic genital herpes compared to 0.4% of persons who were HSV-1 positive. Valtrex once daily Daily Therapy Cuts Herpes Transmission Risk - WebMD, Once-Daily Valacyclovir to Reduce the Risk of Transmission of. Metoprolol contraindications The objective of this study was to provide the first evaluation of valacyclovir 1 g once daily compared to placebo in reducing viral shedding in. Once Daily Valacyclovir for Reducing Viral Shedding in Subjects.. VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2.. Genital HSV Infections - 2015 STD Treatment Guidelines - CDC. HOW SUPPLIED. Valacyclovir/Valacyclovir Hydrochloride/Valtrex Oral Tab 1g, 500mg. The CDC recommends this same dose or 1 g PO once daily for 5 days. Oct 1, 2004. The infected source partner of each enrolled couple was randomized to receive valacyclovir in a dosage of 500 mg or placebo taken once daily. Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in.