Comparative efficacy and safety of preventive treatment with cytovir-3 and arbidol in children during seasonal outbreak of respiratory viral infection (an open-label randomized clinical study)

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Abstract

Aim: To compare the safety and prophylactic efficacy of Cytovir-3 and Arbidol in an open-label randomized clinical trial in children at seasonal risk of infectious respiratory disease.

Methods: This study was performed in the period preceding a seasonal outbreak of acute respiratory viral infections (ARVI) and influenza. The study enrolled apparently healthy children aged 6 to 18 years without contra-indications to either Cytovir-3 or Arbidol. Cytovir-3 was given as 1 capsule per day, each day in a fasted state for 12 days. Arbidol was taken as a 100 mg capsule twice a week for three weeks. Following dosing, subjects were followed-up for a further three weeks. Overall health and presence of symptoms of either ARVI or influenza were monitored daily in all subjects. The level of sIgA in saliva was baselined before treatment and measured at the end of the follow-up period.

Results: Most subjects did not exhibit any change in overall health status during the dosing and follow-up periods. The first two cases of illness in subjects receiving Cytovir-3 were diagnosed at the end of the third week after completion of dosing. In those subjects receiving Arbidol the first cases of illness were reported at the end of the second week following the end of prophylactic dosing. All patients displayed a significant increase in sIgA level at the end of the dosing period, but this was more pronounced in the Cytovir-3 group. 

Conclusion: The results of this comparative randomized clinical trial confirmed the safety and tolerability of both medications, and that the prophylactic efficacy of Cytovir-3 is equal to that of Arbidol.

About the authors

V. S. Smirnov

JSC MВSPC “Cytomed”

Author for correspondence.
Email: vssmi@mail.ru
ORCID iD: 0000-0002-2723-1496

Smirnov Vyacheslav S., PhD, MD (Medicine), Professor, Head Researcher

Contacts: Vyacheslav S. Smirnov 191023, Russian Federation, St. Petersburg, Muchnoy lane, 19, JSC MBSPC “Cytomed”. 

Russian Federation

S. A. Saveliev

JSC MВSPC “Cytomed”

Email: ssaveliev@cytomed.ru
Savelyev Sergey A., PhD (Biology), Officer of the Registration Department Russian Federation

S. V. Petlenko

JSC MВSPC “Cytomed”

Email: spetlenko@cytomed.ru
Petlenko Sergey V., PhD, MD (Medicine), Head of Clinical Department Russian Federation

G. Redlich

Implicit bioscience Ltd

Email: garry.redlich@implicitbioscience.com

Redlich Garry, Chief Executive Officer & Managing Director

Brisbane

Australia

M. K. Erofeeva

Smorodintsev Research Institute of Influenza

Email: mariana.erofeeva@influenza.spb.ru
Erofeeva Mariana K., PhD, MD (Medicine), Head of the Laboratory for Testing New Means for Protection Against Viral Infections Russian Federation

A. V. Lyovina

JSC MВSPC “Cytomed”

Email: alevina@cytomed.ru
Lyovina Anna V., Officer of Clinical Department Russian Federation

N. I. Zavialova

JSC MВSPC “Cytomed”

Email: nzavialova@cytomed.ru
Zaviyalova Natalia I., Officer of Clinical Department Russian Federation

References

  1. Ельшина Г.А., Харит С.М., Романенко В.В., Комлева С.В., Пучкова Н.Г., Чирун Н.В., Абрамова М.А., Лонская Н.И., Горбунов М.А. Результаты изучения безопасности и иммуногенности отечественных субъединичных адъювантных пандемических моновакцин группы гриппол® у детей от 6 месяцев до 17 лет //Эпидемиология и вакцинорофилактика. 2011. № 2 (57). C. 41–46.
  2. Кузьменко Л.Г., Котлуков В.К., Антипова Н.В. Современные возможности применения комбинированных препаратов для лечения острых респираторных инфекций у детей //Педиатрия. 2013. Т. 92, № 4. С. 71–76.
  3. Сепетлиев Д. Статистические методы в научных медицинских исследованиях. М.: Медицина, 1968. 207 с.
  4. Смирнов В.С. Профилактика и лечение гриппа и острых респираторных вирусных инфекций. СПб.: ФАРМиндекс, 2008. 50 c.
  5. Смирнов В.С., Куликов С.В., Власов В.Ю. Фармацевтическая композиция для лечения вирусных заболеваний. Патент № 2155254, 2001.
  6. Смирнов В.С., Селиванов А.А. Биорегуляторы а профилактике и лечении гриппа. СПб.: Наука, 1996. 69 c.
  7. Шумилов В.И., Шустер А.М., Лобастов С.П., Шевцов В.А., Медников Б.Л., Пилавский С.А., Литус В.И. Эффективность арбидола в профилактике и лечении острых респираторных вирусных инфекций у военнослужащих //Военно-медицинский журнал. 2002. Т. 323, № 9. С. 51–53.
  8. Alves Galvão M.G., Rocha Crispino Santos M.A., Alves da Cunha A.J. Amantadine and rimantadine for influenza A in children and the elderly. Cochrane Database Syst. Rev., 2014, iss. 11: CD002745. doi: 10.1002/14651858.CD002745.pub4
  9. Bergmeier L.A., Wang Y., Lehner T. The role of immunity in protection from mucosal SIV infection in macaques. Oral Dis., 2002, vol. 8, suppl. 2, pp. 63–68.
  10. Blaising J., Polyak S.J., Pécheur E.I. Arbidol as a broad-spectrum antiviral: an update. Antiviral Res., 2014, vol. 107, pp. 84–94. doi: 10.1016/j.antiviral.2014.04.006
  11. De Clercq E., Li G. Approved antiviral drugs over the past 50 years. Clin. Microbiol. Rev., 2016, vol. 29, pp. 695–747. doi: 10.1128/CMR.00102-15.
  12. Doll M.K., Winters N., Boikos C., Kraicer-Melamed H., Gore G., Quach C. Safety and effectiveness of neuraminidase inhibitors for influenza treatment, prophylaxis, and outbreak control: a systematic review of systematic reviews and/or meta-analyses. J. Antimicrob. Chemother., 2017, vol. 72, no. 11, pp. 2990–3007. doi: 10.1093/jac/dkx271
  13. Executive summary of the 6th meeting of the WHO Expert Working Group of the GISRS for Surveillance of Antiviral Susceptibility. Wkly Epidemiol. Rec., 2017, vol. 92, no. 41, pp. 611–612.
  14. Fisher R.A. Statistical methods for research workers. 14th edition. Edinburgh: Oliver&Boid, 1970. 362 p.
  15. Jiménez-García R., Hernandez-Barrera V., Rodríguez-Rieiro C., Carrasco Garrido P., López de Andres A., Jimenez-Trujillo I., Esteban-Vasallo M.D., Domínguez-Berjón M.F., Miguel-Diez J., Astray-Mochales J. Comparison of self-report influenzavaccination coverage with data from a population based computerized vaccination registry and factors associated with discordance. Vaccine, 2014, vol. 32, no. 35, pp. 4386–4392. doi: 10.1016/j.vaccine.2014.06.074
  16. Rainwater-Lovett K., Chun K., Lessler J. Influenza outbreak control practices and the effectiveness of interventions in long-term care facilities: a systematic review. Influenza Other Respir. Viruses, 2014, vol. 8, no. 1, pp. 74–82. doi: 10.1111/irv.12203

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Copyright (c) 2019 Smirnov V.S., Saveliev S.A., Petlenko S.V., Redlich G., Erofeeva M.K., Lyovina A.V., Zavialova N.I.

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