Comparative assessment of the effectiveness and safety of an interferon inducer in the complex treatment of viral respiratory tract Infections in children aged 3-18 years in real-world practice during the 2023-2024 respiratory disease season

Background. Viral respiratory tract infections treatment, especially during epidemic outbreak, is a main priority for pediatricians and physicians of other specialties. After the COVID-19 pandemic, a need to assess the efficacy and safety of the interferon inductor drug arose due to the changes of respiratory viruses circulation.

Objective. To evaluate the effectiveness of drug within the complex therapy of viral respiratory tract infections in children aged 3 to 18 years, in comparison with standard therapy in routine outpatient practice.

Materials and Methods. The study included 534 children aged 3 to 18 years diagnosed with mild to moderate viral respiratory tract infections with a disease duration of no more than 3 days at the time of enrollment in the observational program. Standard therapy was prescribed by the attending physician in accordance with current Clinical Guidelines and Treatment Standards. Additionally, Кagocel® tablets, 12 mg, were administered at the physician’s discretion, in doses of 6 or 10 tablets over a period of 4 days. Symptom dynamics, disease duration, incidence of complications, antibiotic prescriptions, recurrent viral respiratory tract infections, and viral pathogen elimination based on PCR diagnostics were assessed. Safety assessment included adverse event recording.

Results. Incorporating of interferon inductor into standard therapy reduced the duration of the primary disease and accelerated symptom resolution, decreased the frequency of complications, antibiotic prescriptions, and recurrent viral respiratory tract infections. Complex therapy with an Кagocel® provided twice the effectiveness in terms of viral elimination rates compared to standard therapy without antiviral agents on days 5-8 from the start of treatment. Кagocel® demonstrated a good adverse event profile, with no AEs recorded.

Conclusion. The significant efficacy of interferon inductor in the complex treatment of viral respiratory tract infections compared to standard therapy without antiviral agents in real-world practice has been demonstrated. The therapy demonstrated an excellent adverse event profile in children aged 3 to 18 years.

1. Federal Service for Supervision of Consumer Rights Protection and Human Welfare. On the state of sanitary-epidemiologic well-being of the population in the Russian Federation in 2023: State report. 2024. (In Russ.)

2. Savenkova M. S., et al. Evaluation of probiotics efficacy in children in complex therapy of acute respiratory infections with gastrointestinal disorders in outpatient conditions. Lechashhiy vrach. 2023; 9: 31-42. (In Russ.)

3. Mazankova L. N., Gorbunov S. G., Samitova E. R. The value of interferon therapy for COVID-19 in children. Detskie infektsii.2021; 20 (1): 34-38. (In Russ.)

4. Malyavin A. G., et al. Therapy of patients with COVID-19: results of efficacy and safety evaluation of Ingavirin® inclusion in the regimen of recommended standard therapy in real clinical practice. Terapiya. 2021; Vol. 7, № 5 (47): 22-32. (In Russ.)

5. Zhou Q., et al. Interferon-α2b Treatment for COVID-19. Front Immunol. 2020; 11: 1061.

6. Karetkina G. N. Influenza and other acute respiratory infections: modern principles and practice of treatment. Meditsinskiy Sovet. 2017; 5: 54-57. (In Russ.)

7. Ershov F. I., Kiselev O. I. Interferons and their inducers (from molecules to drugs). Moscow: GEOTAR-Media, 2005. 368 p. (In Russ.)

8. Research Institute of Influenza NWO RAMS. Study of virus-inhibitory activity of Kagocel in combination with arbidol against H1N1 influenza virus. Research report. 2009. (In Russ.)

9. Fazylov V. H., et al. Effect of antiviral therapy on the incidence of bacterial complications and prescription of antibacterial drugs for systemic use in patients with acute respiratory viral infections and influenza (results of the FLU-EE international observational cohort study): 11-12. Antibiotiki i himioterapiya 2016; 11-12 (61): 39-47. (In Russ.)

10. Savenkova M. S., et al.Analysis of comparative treatment of acute respiratory viral infections in the 2015-2016 epidseasons based on the results of multiplex PCR diagnostics in outpatient practice settings.2017; 1: 38-46. (In Russ.)

11. FSBI "Children's SCC of Infectious Diseases of FMBA".Clinical recommendations (treatment protocol) of medical care for children with influenza. (In Russ.)

12. Union of Pediatricians of Russia. Clinical recommendations of the Ministry of Health of the Russian Federation "Acute respiratory viral infection in children". 2021. (In Russ.)

13. General characteristics of the medicinal product Кagocel®, RU LP- N(002233)-(RG-RU) from 30.01.2024 (In Russ.)

14. Boldina N. V., et al. Applications of antibiotics in children, their adverse reactions. Kursk, 2023. P. 115-118. (In Russ.)

15. Vartanyan R. V., Sergeeva E. M., Cheshik S. G. Evaluation of therapeutic efficacy of Cagocel® in infants and preschool children with acute respiratory viral infections. Detskie infektsii. 2011; 1 (10): 36-41. (In Russ.)

16. Kharlamova F. S., et al. Clinical efficacy of Cagocel® in influenza and acute respiratory viral infections in children from 2 to 6 years of age. Detskie infektsii.2010; 4 (9): 34-41. (In Russ.)

17. Chernova T. M., Subbotina M. D., Rubtsova S. K. Effectiveness of the drug Cagocel® in viral lesions of the gastrointestinal tract in children. Medicinskiy sovet. 2015; 1: 40-45. (In Russ.)