Valtrex studies

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    Valtrex studies


    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. This Phase II study will test the efficacy of the anti-viral drug valacyclovir (Valtrex) in treating adults with mild Alzheimer's disease who also test positive for herpes simplex virus-1 (HSV-1) or HSV-2. HSV-1 (oral herpes) and HSV-2 (genital herpes) are known to trigger amyloid aggregation and their DNA is commonly found in beta-amyloid plaques, which are a hallmark of Alzheimer's disease. Food & Drug Administration to treat herpes and shingles. In studies in mice, anti-HSV drugs have reduced accumulation of beta-amyloid and p-tau, another protein found in the brains of people with Alzheimer's disease. This study will test valacyclovir as a possible treatment in slowing or preventing Alzheimer's disease. Participants will take four to eight coated tablets of either 500 mg of valacyclovir or placebo daily for 78 weeks. Researchers will measure amyloid accumulation on PET scans in multiple regions of the brain, as well as changes in cognitive function and activities of daily living using assessments and tests. Investigators also will obtain measures of beta-amyloid and tau in cerebrospinal fluid from participants who agree to lumbar puncture.

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    Valtrex Lowers Herpes Transmission. In the study heterosexual. Corey's study shows "Valtrex provides another safeguard," he says. "If they take the pill all the time, they can reduce the. For the Valacyclovir HSV Transmission Study Group. Population-based studies in the United States indicate that 22 percent of adults have antibodies to HSV-2. Five placebo and 12 valacyclovir source partners experienced an adverse event leading to discontinuation during double-blind therapy. Headache was the most common adverse event leading to discontinuation of study drugs. Sixteen pregnancies occurred during the study 8 in the valacyclovir group, 8 in the placebo group.

    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. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Listing a study does not mean it has been evaluated by the U. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation.

    Valtrex studies

    A Study of Valacyclovir as Treatment for Genital Herpes., Once-Daily Valacyclovir to Reduce the Risk of Transmission of.

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  6. Suppressive valacyclovir therapy has been shown to significantly reduce HSV. In contrast, other studies have shown that appropriate counseling can.

    • Suppressive valacyclovir therapy to reduce genital herpes..
    • Valtrex For Reducing Transmission of Genital Herpes- FDA..
    • Can high-dose antiherpes therapy eliminate genital HSV-2 shedding?.

    A Valtrex valacyclovir is an antiviral medication classified by the U. S. Food and Drug Administration FDA as Pregnancy Category B. Studies of Valtrex performed in animals, at doses which. The use of VALTREX for treatment of cold sores is based on 2 double-blind, placebo-controlled clinical trials in healthy adults and adolescents aged greater than or equal to 12 years with a history of recurrent cold sores see Clinical Studies 14.1. Valtrex is indicated for the treatment of herpes zoster shingles and ophthalmic zoster in. Clinical studies have not been conducted in HSV-infected patients.

     
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