A Double-Blind Placebo-Controlled Study to Evaluate Valacyclovir Alone and with Aspirin for Asymptomatic HSV-1 DNA Shedding in Human Tears and Saliva

PURPOSE. To test the effect of valacyclovir alone and with aspirin on the asymptomatic shedding of HSV-1 DNA in tears and saliva of healthy individuals. METHOD. The subjects (n = 45) were randomized into three groups without regard to age, sex, or race. Group 1 (n = 14) received the placebo, group 2 (n = 15) received a dose of 500 mg valacyclovir once daily, and group 3 (n = 16) received a dose of 500 mg valacyclovir once daily and 350 mg aspirin twice daily for 30 days. Ocular and oral swabs were collected twice daily for 30 days. DNA was extracted from all swabs and HSV-1 DNA copy numbers were determined. Statistical analysis was performed to compare the DNA copy numbers of the three groups. RESULTS. There was no significant difference in the HSV-1 DNA copy numbers in the tears or saliva among any of the three treatment groups. The mean copy numbers +/- SE of mean (SEM) of HSV-1 DNA in tears were 340 +/- 35, 1074 +/- 320, and 630 +/- 51 for groups 1, 2, and 3, and in saliva were 238 +/- 35, 963 +/- 462, and 493 +/- 25, respectively, for groups 1, 2, and 3. CONCLUSIONS. No correlation was found between HSV-1 shedding and valacyclovir and valacyclovir with aspirin treatment. The HSV-1 DNA copy number was not reduced by treatment with 500 mg of valacyclovir daily or with a combination of daily valacyclovir (500 mg) plus twice-daily doses of aspirin (350 mg) over 30 days. (Invest Ophthalmol Vis Sci. 2009; 50: 5601-5608) DOI: 10.1167/iovs.09-3729