National and foreign research of Anaferon Kid: efficacy, safety and experience of application (review)

Interest in acute respiratory viral infections (ARVI) in children does not tend to decrease and is determined by their high prevalence, relatedness to «uncontrollable infections» in most cases and presence of age limits in the use of antiviral drugs. Presently, focus on the use of national drugs is made in the RF clinical practice. An innovative drug Anaferon for children was developed by the Russian pharmaceutical company OOO «NPF «Materia Medica Holding» and registered in Russia in 2002.

The summary purpose is to classify and analyze national and international publications on the results of non-clinical and clinical investigation of Anaferon for children efficacy and safety in ARVI and other viral infections.

Study method: exploratory and analytical.

Results: the summary presents the data of non-clinical studies justifying the drug mechanism of action at molecular level ensuring its combined antiviral and immunomodulating efficacy. The results obtained in the experiment were verified by clinical studies and are reflected in numerous scientific publications including international ones. The summary contains analysis of the results of clinical studies of the drug in children with ARVI including influenza. Anaferon for children was found to reduce duration of the main clinical symptoms of ARVI and influenza, incidence of bacterial complications, it is well-tolerated and has high safety profile. The open-label randomized comparative study of Anaferon for children efficacy and safety vs. Oseltamivir in influenza demonstrated clinical efficacy of these drugs. Numerous publications evidence that Anaferon for children exerts antiviral effect against most viruses causing acute respiratory viral infections as well as herpes viruses, viruses causing intestinal infections and tick-borne encephalitis. The list of scientific publications on the drug consists of approximately 800 references including more than 50 articles in foreign languages, particularly in journals with high citation index.

1. Kondurina E.G . Practica pediatra. 2015: 56-63 (in Russian).

2. Instrukcija k preparatu Anaferon detskij [Jelektronnyj resurs] // Rezhim dostupa: http://grls.rosminzdrav.ru/InstrImg.aspx? idReg=12137&t =&is Old=1. (in Russian).

3. Tarasov S, Gorbunov E, Myslivets M, Rodionova N, Epstein O. Novel antibody-based biotechnological approach of influenza management: Summary of preclinical and clinical studies//Basic & clinical pharmacology & toxicology. 2014; 115: 230.

4. Gavrilova ES, Bobrovnik SA, Sherriff G, Myslivets AA, Tarasov SA, Epstein OI. Novel Approach to Activity Evaluation for Release-Active Forms of Anti-Interferon-Gamma Antibodies Based on Enzyme-Linked Immunoassay. PLоS ONE. 2014; 9 (5): 1-9.

5. Tarasov SA, Zarubaev VV, Gorbunov EA. et al. Activity of ultra-low doses of antibodies to gamma-interferon against lethal influenza A(H1N1)2009 virus infection in mice. Antiviral. Res. 2012; 93(2): 219-224.

6. Zhavbert, E.S., Dugina Ju.L., Jepshtejn O.I. Antibiotiki i himioterapija.2013;5-6(58): 17-23 (in Russian).

7. Jepshtejn O.I., Shtark M.B., Dygaj A.M. i dr. Farmakologija sverhmalyh doz antitel k jendogennym reguljatoram funkcij. M.: Izd-vo RAMN; 2005: 226 s (in Russian).

8. Jepshtejn O.I. Bjul. jeksper. biol. i med. 2012; 154 (7): 62-67 (in Russian).

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12. Voronova OL, Rogozina OP. Issledovanie mutagennyh svojstv lekarstvennyh preparatov, soderzhashhih sverhmalye dozy antitel k jendogennym reguljatoram funkcij. V: Materialy VI mezhdunarodnoj konferencii «Klinicheskie issledovanija lekarstvennyh sredstv». M; 2007. p. 38-39 (in Russian).

13. Malahov, A.B. Poliklinika. 2014; 6: 1-5 (in Russian).

14. Volkov, I.K. Trudnyj pacient. 2014; 12(5): 10-16 (in Russian).

15. Lobzin Y, Volzhanin VM, Babachenko IV. Antiviral efficacy and interferon inducing activity of the release-active antibodies to interferon-gamma in children with influenza: results of randomized comparative (vs oseltamivir) parallel-group clinical study, season 2012-2013//European Congress of Clinical Microbiology and Infectious Diseases. – Berlin, Germany: April 27-30, 2013. – LB2955.

16. Andrianova E, Zak M. The efficacy and safety of use of anaferon for children in the treatment of influenza and other acute respiratory viral infections in children//International congress of pediatrics (ICP). – Melbourne, Australia: August 24-29, 2013. [Jelektronnyj resurs] // Rezhim dostupa: http:// www.abstractserver.com/espid2013/planner/.

17. Kuligina, Ju. Medicinskij vestnik. 2013; 13-14 (626-627):16 (in Russian).

18. Zaplatnikov A. Evaluation of efficacy of interferon inducer in treatment of the recurrent acute respiratory viral infections in children//31st Annual Meeting of the European society for paediatric infectious diseases, Milan, Italy, May 28- June 1, 2013. [Jelektronnyj resurs] // Rezhim dostupa: http://w3.kenes-group. com/apps/ espid2013/abstracts/PDF/734.pdf?zoom_highlightsub=Zaplatnikov#search= “Zaplatnikov”.

19. Zaplatnikov A. Prevention of the recurrent acute respiratory viral infections in children//31st Annual Meeting of the European society for paediatric infectious diseases, Milan, Italy, May 28-June 1, 2013. - [Jelektronnyj resurs] // Rezhim dostupa: http://w3.kenes-roup.com/apps/espid2013/abstracts/PDF/1156.pdf?zoom_highlightsub =Zaplatnikov#search=”Zaplatnikov”

20. Gorelov A. Evaluation of efficacy of interferon inducer in prevention of the nosocomial gastrointestinal infections in children//31st Annual Meeting of the European society for paediatric infectious diseases, Milan, Italy, May 28-June 1, 2013. - [Jelektronnyj resurs] // Rezhim dostupa:http://w3.kenes-group.com/apps/ espid2013/abstracts/PDF/1143.pdf?zoom_highlightsub= Gorelov#search=”Gorelov”.

21. Gorelov A., Ploskireva A. Evaluation of efficacy of interferon inducer in treatment of acute gastroenteritis in children//31st Annual Meeting of the European society for paediatric infectious diseases, Milan, Italy, May 28-June 1, 2013. -[Jelektronnyj resurs] // Rezhim dostupa: http://w3.kenesgroup. com/apps/espid2013/ abstracts/PDF/592.pdf? zoom_highlightsub =Gorelov#search=”Gorelov”.

22. Kondiurina E., Elkina T., Zelenskaya V., Timinskaia N., M. Shably M. Prevention of the recurrent acute respiratory viral infections and virus-induced exacerbation of bronchial asthma in children. [Jelektronnyj resurs] // Rezhim dostupa: http:// www.erscongress2013.org/images/pdf/ERS_Final_programme_Barcelona.pdf.

23. Gavrilova E., Gorbunov E., Borshcheva A., Guryanova N., Tarasov S. Application of drugs based on release-active antibodies as immunotherapy agents//J. of Clinical & Cellular Immunology. 2014; 5 (5): 62.

24. Marteushev AV, Sherstoboyev EYu, Sergeeva SA, Belskiy YuP, Dygai AM, Goldberg ED, Epshtein OI. Ultralow doses of antibodies to interferon gamma (ULD anti – IFNγ) as a novel immunomodulator//Pharmacologist, XIV World Congress of Pharmacology The New Century of Pharmacology, Abstract Volume, July 7 – 12, 2002 Moscone Convention Center San Francisco California. 2002; 44 (2 ) (Suppl.1): A 240

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27. Kiselev O.I., Ershov F.I., Deeva Je.G. Interferon-gamma: novyj citokin v klinicheskoj praktike. Ingaron. M.: Dimitrejd Grafik Grupp; 2007: 348 s. (in Russian).

28. Rukovodstvo po virusologii: Virusy i virusnye infekcii cheloveka i zhivotnyh / Pod red. akademika RAN D.K. L’vova. — M.: OOO «Izdatel’stvo «Medicinskoe informacionnoe agentstvo »; 2013: 1200 s. (in Russian).

29. Romancov M.G., Mel’nikova I.Ju., Ershov F.I. Respiratornye zabolevanija u chasto bolejushhih detej: nastol’nyj spravochnik vracha. M.: GJeOTAR-Media; 2015: 160 s. (in Russian).

30. Grigorjan S.S., Ershov F.I. Metodicheskie principy opredelenija interferonovogo statusa. V kn.: Ershov F.I. Sistema interferona v norme i pri patologii. M.; 1996: S. 147 – 155 (in Russian).