No safety issues observed with combination treatment for recurrent herpes simplex labialis

December 27, 2010

Treatment of recurrent herpes simplex labialis with combination 5% acyclovir and 1% hydrocortisone cream is safe in adolescents. In a study of a 5-day treatment course, no safety concerns were identified, said Anders Strand, MD, PhD, at the 45th midyear meeting of the American Society of Health Systems Pharmacists, in Anaheim, Calif.

Treatment of recurrent herpes simplex labialis with combination 5% acyclovir and 1% hydrocortisone cream is safe in adolescents. In a study of a 5-day treatment course, no safety concerns were identified, said Anders Strand, MD, PhD, at the 45th midyear meeting of the American Society of Health-Systems Pharmacists, in Anaheim, Calif.

He reported the results of a single-arm, open-label multicenter phase 3 study in which 254 patients aged 12 to 17 years were instructed to initiate treatment with combination 5% acyclovir and 1% hydrocortisone cream 5 times daily for 5 days at the first sign or symptoms of herpes simplex labialis recurrence (preferably prior to the first clinical sign of a cold sore).

Of the 254 subjects, 120 did not experience a recurrence and were not treated. One hundred thirty two subjects who were treated with combination 5% acyclovir and 1% hydrocortisone cream and completed the study were included in the analysis.

Five adverse events were recorded in 5 subjects during the study; 3 were mild in intensity and 2 were moderate in intensity, said Dr Strand, Department of Medical Sciences, Dermatology and Venereology, University Hopsitals, Uppsala, Sweden.

These were secondary oral herpes infection (2 cases), infectious rhinitis, asthma, and application-site inflammation. Only application-site inflammation was considered to be related to the study medication, and led to withdrawal from the study.

Of the 132 subjects with a recurrence who completed the study, herpes recurrence consisted of a single lesion in 126 and 2 lesions in 6. About 60% had non-ulcerative recurrences and 40% had ulcerative recurrences.

Lesions healed completely in all evaluable subjects.

“Despite the self-resolving characteristic of herpes simplex labialis and subsequent latency, medical treatment for herpes simplex labialis should always be considered,” said Dr Strand.