Source: J Indian Med Assoc  |  Posted 7 years ago

By Eurona Earl Tilley

PRAGUE, CZECH REPUBLIC -- May 3, 2004 -- Anaferon, a new antiviral and immunomodulating drug currently marketed in Russia, was shown to have therapeutic and prophylactic applications for upper respiratory infections (URIs) in children over 6 months of age.

Andrey V. Martyushev-Poklad, MD, PhD, presented these findings here May 2nd at the 14th European Congress on Clinical Microbiology and Infection Diseases.

Dr. Martyushev-Poklad, Senior Research Associate, Materia Medica Research and Production Company, which manufactures anaferon, explained that acute URI's, such as influenza, are a leading cause of morbidity in adult and paediatric populations. Over 200 viruses can be attributed to these infections, he said.

"There is an unmet need in managing URI, most urgent in the paediatric population," Dr. Martyushev-Poklad said. Anaferon contains small doses of antibodies to gamma-interferon, he said.

To explore the safety and efficacy of anaferon for treating or preventing the development of URIs, Dr. Poklad and colleagues designed two studies. In a randomised, placebo-controlled study of 390 in- and outpatients between the ages of 6 months and 14 years, oral tablets of anaferon were administered 3 to 7 times daily on day 1 of infection and continued for 5 to 7 days. In another randomised, placebo-controlled study, 400 children, ages 6 months to 4 years, were given oral tablets 1 or 3 times daily for a period of 3 months.

Patient who developed an upper respiratory infection during the trial received the recommended therapeutic schedule of 3 to 7 oral tablets for approximately 1 week.

Results showed that anaferon therapy decreased the severity and duration of symptoms as well as the rate of complications associated with URI. When compared to the placebo group, the duration of fever was reduced by 35% to 40%, the duration of intoxication was reduced by 40% to 50%, the duration of runny nose by 20%, and the duration of cough by 30%.

Anaferon treatment resulted in an induction of interferon-gamma and alpha by the second or third day. The participants suffered no anaferon-related adverse events during this study, Dr. Martyushev-Poklad said.

As a result of anaferon prophylaxis, URI morbidity decreased 2- to 2.3-fold when compared with the placebo group. The effects were greatest among children with a high morbidity at baseline, such as those who were immunocompromised. In addition, 24.7% of the children who received anaferon avoided the development of URIs. In the placebo group, 3% did not develop an infection.

There were 1.5 to 2 fold fewer symptoms of URIs among children who were treated with anaferon. The rate of common URI complications, such as otitis and purulent rhinitis, was decreased 2.3- and 2.1-fold in the children who received 1 or 3 tablets per day, respectively. Similarly, like in the therapeutic study, participants suffered no anaferon-related adverse events.

Dr. Martyushev-Poklad concluded that he hopes other physicians around the world will soon be able to prescribe anaferon, allowing it to benefit a greater number of children.

[Presentation title: "A novel antiviral based on oral antibodies: clinical benefits in paediatric upper respiratory infections." Abstract #P551]