If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ICAR: Acyclovir Cream Significantly Reduces Herpes Simplex Labialis Lesion Pain By Claire Sowerbutt Special to DG News
SEATTLE, WA -- April 11, 2001 -- Topical acyclovir cream, widely used in Europe and other countries outside the United States to treat herpes labialis, has not yet been approved by the American Food and Drug Administration (FDA). Different from acyclovir ointment, the cream has not been approved due to lack of substantial clinical trial data. However, data from two large, American multi-center, randomized, double-blind, placebo controlled trials, show that acyclovir cream not only has superior efficacy to the ointment and researchers saw a statistically significant reduction in the duration of lesion pain in both studies. The results of the studies were presented at the 14th International Conference on Antiviral Research in Seattle, Washington. The objectives were to primarily determine the efficacy and safety of 5% acyclovir cream in reducing the duration of herpes labialis episodes, and secondarily to reduce the pain associated with this viral infection. Patients entering the study were screened for eligibility and randomized to either acyclovir or vehicle cream, and told to self-initiate treatment within one hour of the next recurrent herpes labialis episode. None of the patients were immunocompromised. "These studies are called ‘patient initiated trials.’ It was done this way in order to get the medicine onto the lesion at the very earliest opportunity, to maximize the effect of therapy," said Dr. Spotswood L. Spruance, of the Acyclovir Study Group, International Society of Antiviral Research. The dosing regimen was five times daily for four days, with 686 patients who treated a lesion in study 1, and 699 in study 2. The median time to treatment was half an hour. Data from study 1 for the mean duration of recurrent episodes was 4.3 days for patients in the acyclovir arm, and 4.8 days for those treated with the vehicle control: (HR=1.23, 95 percent CI: 1.06 - 1.44, p=0.007). Data from study 2 showed the mean duration of recurrent episodes was 4.6 days for acyclovir patients, and 5.2 days for the placebo treated patients. (HR=1.24, 95 percent: CI: 1.06-144, p=0.006). Interestingly, there was no difference in the effect among the patients that started therapy in the early (prodrome/erythema) stage of the illness, and those patients who started therapy in the late (papule, vesicle or crusted) stage of the illness. "These trials show that acyclovir cream produces a statically significant reduction in the duration of the episode and the duration of lesion pain in these patients," Dr. Spruance said. The studies, which meet regulatory standards, are the first of their kind for acyclovir cream in the United States. It is hoped that FDA approval will be sought.
|
