BioAlliance Pharma SA (Euronext Paris-BIO), a company dedicated to the supportive care and treatment of cancer patients, has presented the preliminary results of a study in patients suffering from herpes labialis in the United States and Europe. Given that treatment with Sitavir® (acyclovir Lauriad™) has proven efficacy in recurrent herpes labialis, the company considered it was important to better understand the characteristics of these patients affected by this recurrent disease.
Herpes labialis affects 50 million people in the US and 45 million in Europe each year. The study results included 2007 patients (1002 in the United States and 1005 in Europe-France) and are representative of epidemiological data on herpes labialis in terms of patient age, gender ratio and recurrence. In the United States, 74% of the patients were under the age of 49 (84% in France) and 59% were female (58% in France). Thirty-five percent of the study population presented 4 episodes and more a year (35% in France), with an annual average of 6 episodes.
Forty-six per cent of the US patients suffering from 4 episodes and more a year and with a medical prescription for herpes are welcoming a treatment that would treat herpes labialis and delay the occurrence of the following episode (38% in France).
Among the US patients with a medical prescription for herpes, 35% percent spontaneously stopped working on their own due to discomfort and significant inconvenience (17% in France) and among them, 66% had a sick leave prescription by a physician (59% in France).
Of the 1002 US patients, 44% had experienced an episode of herpes labialis in the 4 weeks preceding the study (47% in France). Use of a validated questionnaire revealed a significant alteration in quality of life of patients suffering from 4 episodes and more a year, relative to those suffering from fewer than 3 episodes a year (pain, physical disability and limited activities).
“These epidemiological results are very important for Sitavir® (acyclovir Lauriad™), indicated for recurrent herpes labialis and for which we intend to file marketing authorization in Europe and the US in Q3/Q4 2011. When recurrent, this local infection has an impact on quality of life. Patients with recurrent herpes labialis clearly have unmet medical needs”, commented BioAlliance Pharma CEO, Dominique Costantini. “This study also tells us more about patients’ treatment habits. It will yield valuable health economic data for the US and Europe and should also generate publications”.