New Cream May Prevent Cold Sore Recurrence
San Francisco — A newly approved cream containing 5% acyclovir and 1% hydrocortisone prevented ulcerated lesions in patients with recurrent herpes simplex labialis, compared with both topical acyclovir and placebo, a large multicenter study showed.
The product, ME-609 (Lipsovir), was approved for marketing in the United States in late July and is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten lesion healing time.
"This is the first product to prevent the development of cold sores," Dr. Spotswood L. Spruance said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. "Other products have been shown to reduce the duration of the disease, but this has been shown to block the development of ulcers and blisters."
Developed by Medivir of Huddinge, Sweden, ME-609 is not yet available in the United States because Medivir has not yet partnered with a company to distribute and market the product. A company spokeswoman estimated that ME-609 would be available in the United States some time in 2010.
For the study, researchers led by Dr. Christopher M. Hull of the department of dermatology at the University of Utah, Salt Lake City, randomized 1,443 patients aged 18 years and older with at least three episodes of herpes simplex labialis to one of three treatment groups: ME-609 vehicle containing 5% acyclovir and 1% hydrocortisone (n=601), acyclovir alone in ME-609 vehicle (n=610), or placebo (n=232).
The patients were instructed to start treatment at home five times daily for 5 days at the earliest sign or symptom of their next recurrence of herpes simplex labialis, and to keep a diary of symptoms.
The mean age of patients was 44 years, and 28% were male.
Dr. Spruance of the division of infectious diseases at the University of Utah reported that, at the end of treatment, the proportion of patients with nonulcerative recurrences was 42% in the ME-609 group, compared with 35% for acyclovir and 26% for placebo.
Among patients who developed an ulcerative lesion despite treatment, the duration of lesions was reduced by ME-609 to a similar extent as acyclovir alone (a mean of 5.7 days vs. a mean of 5.9 days, respectively); both were significantly shorter than placebo (a mean of 6.5 days), he said at the meeting, which was sponsored by the American Society for Microbiology.
Lesion healing time was reduced by ME-609 to a similar extent as acyclovir alone (a mean of 9.6 days vs. 9.9 days, respectively), with both significantly shorter than placebo (11 days).
The cumulative lesion area was reduced by one-half in the ME-609 group, compared with the placebo group, and the differences in cumulative lesion area between ME-609 and the other two groups were statistically significant.
Frequency of secondary herpes recurrences was 5% in the ME-609 group, 7% in the acyclovir group, and 7% in the placebo group, while the proportion of patients with positive viral cultures was 22%, 24%, and 40%, respectively.
The frequency and nature of adverse events was similar between the groups.
Medivir funded the study. Dr. Spruance disclosed that he is a paid consultant for the company.
This product 'has been shown to block the development of ulcers and blisters.'
Source DR. SPRUANCE
