Arbidol studies and results

Arbidol studies and results

Arbidol which contains the active ingredient Umifenovir is an antiviral drug for the treatment and prevention of influenza and other acute respiratory viral infections.

  • Included by experts of the International Society for Influenza and Other SARS in the list of antiviral agents for the treatment of influenza (ISIRV).
  • Included in the clinical guidelines of the Ministry of Health of the Russian Federation.
  • Included in the rubricator of the World Health Organization (WHO).

Arbidol blocks the early stage of viral reproduction, preventing the penetration of the virus into the cell by blocking the fusion of viruses with the cell membrane.
American scientists from the leading scientific center The Scripps Research Institute, La Jolla, (San Diego, California), which employs several Nobel Prize winners in the natural sciences, have confirmed the "point" of binding of the drug Arbidol to the influenza virus. At the end of December 2016, the authoritative international journal PNAS (the second most cited specialized publication in the world) published an article on the results of a study on the mechanism of the antiviral action of the Russian drug Arbidol. 1
It was previously demonstrated that the target of the original Russian antiviral drug Arbidol is the surface protein of the influenza virus HA (hemagglutinin). 2

Arbidol is an original development of Russian scientists with international recognition. The following countries took part in the study of the drug: Russia, USA, Great Britain, Australia, Japan, China, Turkey, Ukraine, Belgium, Czech Republic, France, Italy, Spain, Italy, India, etc. Scientific interest in the umifenovir molecule is growing!

In clinical trials on the drug Arbidol in the treatment of influenza and other acute respiratory viral infections in adults and children, as well as in the treatment of acute intestinal infections of viral etiology in children, a total of over 23,000 patients were included, including more than 6,500 children.

The leading scientific institutes and medical institutions of Russia took part in the research of Arbidol:

  • Research Institute of Epidemiology and Microbiology named after Pasteur.
  • Research Institute of Virology named after D.I. Ivanovsky.
  • Research Institute of Influenza of the Ministry of Health of the Russian Federation.
  • Research Institute of Epidemiology and Microbiology named after N.F. Gamaleya.
  • Russian National Research Medical University named after N.I. Pirogov.
  • Moscow Research Institute of Epidemiology and Microbiology named after G. N. Gabrichevsky.

ARBITER CLINICAL STUDY
A randomized multicenter, double-blind, placebo-controlled clinical trial of ARBIDOL in the treatment and prevention of influenza and other acute respiratory viral infections (2011-2017)3.4.
Purpose of the study: To study the efficacy and safety of the drug Arbidol in the treatment and prevention of influenza and other acute respiratory viral infections (ARVI)

  • 359 patients from 18 to 65 years old on outpatient treatment.
  • 15 accredited research centers.

This study was conducted in accordance with the National Standard GOST R 52379-2005 "Good Clinical Practice", which complies with the standards of the Guidelines for Good Clinical Practice (ICH-GCP) of the International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use (ICH ).

RESULTS: Assessment of reduction in disease severity and risk of complications.

  • The proportion of "recovered" patients is up to 20% higher already on the 4th day of the disease.
  • Arbidol increases the proportion of patients with mild infectious disease by 25% and reduces the duration of the acute period of the disease by 5.7 times 36 and 60 hours after the start of therapy, respectively.
  • The proportion of patients with rapid elimination of the virus is up to 40% higher.
  • The proportion of patients with complications is 1.5 times lower.

Publication of interim results (2015)
Publication of final results (2019)


EGIDA CLINICAL STUDY
Large-scale pharmacoepidemic study EGIDA 6.7.

  • 5287 patients aged from 1 month to 89 years (out of 2716 - children) hospitalized in hospitals with a diagnosis of SARS / influenza in the periods of 2010-2011 and 2014-2015.
  • 88 medical institutions from 50 regions of the Russian Federation.

According to the results of the EGIDA study, it was shown:

  • Arbidol reduces the risk of developing complications of influenza and ARVI up to 98%.
  • Arbidol accelerates recovery up to 3 days with flu.
  • Arbidol promotes a faster regression of flu symptoms.

The results of clinical studies and many years of experience in using Arbidol in clinical practice indicate that the drug has a favorable safety profile.

Publication of interim results (2012)
Publication of final results (2017)

References:

1. Rameshwar U. Kadama and Ian A. Wilson. Structural basis of influenza virus fusion inhibition by the antiviral drug Arbidol. PNAS January 10, 2017 114 (2) 206-214;
2. Leneva I. A., Rupert J. Russell, Yury S. Boriskin, Alan J. Hay. Characteristics of Arbidol-Resistant Mutants of Influenza Virus: Implications for the Mechanism of Anti-Influenza Action of Arbidol. Antiviral Research 81 (2009), pp. 132-140
3. Pshenichnaya N.Yu., Bulgakova V.A., Leneva I.A., Maleev V.V., Shestakova I.V. et al. Clinical efficacy of umifenovir in influenza and acute respiratory viral infections (ARBITR study). Therapeutic archive, volume 91, no. 3, p. 56-63
4. O.I. Kiselev, V.V. Maleev, E.G. Deeva, I.A. Leneva, E.P. Selkova, E.A. Osipova, A.A. Obukhov, S.A. Nadorov, E.V. Kulikov. Clinical efficacy of Arbidol (umifenovir) in the treatment of influenza in adults: interim results of a multicenter, double-blind, randomized, placebo-controlled trial ARBITR. THERAPEUTIC ARCHIVE ", No. 1, 2015, pp. 88-96
5. V.F. Uchaikin, O.V. Shamsheva, O. V. Molochkova, V.A. Bulgakov. Pharmaco-epidemiological study of the course of influenza and other acute respiratory viral infections in the 2010/11 season. in children under the age of 18 / Childhood infections, 2012 Volume 11, special issue. S. 9-15
6. V.V. Maleev, E.P. Selkova, I. V. Prostyakov, E.A. Osipova. Pharmaco-epidemiological study of the course of influenza and other acute respiratory viral infections in the 2010/11 season. Infectious Diseases, 2012 Volume 10, No. 3. Pp.15-23.