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Clinical Trials

Date: 2011-02-08

Type of information: Interim results

phase: epidemiological study

Announcement: results of an international survey

Company: BioAlliance Pharma (France)

Product: Sitavir® (acyclovir Lauriad™)

Action mechanism:

Disease:

herpes labialis

Therapeutic area: Infectious diseases

Country: USA, Europe

Trial details:

Latest news:

BioAlliance Pharma 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. 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).

Is general: Yes