Application of HS221GI in treatment of influenza and ARVI in adults: a new approach – managing virus-induced inflammation. Results of a double-blind, randomized, placebo-controlled, multicenter clinical trial

Cover Page

Cite item

Full Text

Abstract

Aim. Evaluation of the efficacy and safety of the drug Aterixen® (XC221GI, 1-[2-(1-methylimidazole-4-yl)-ethyl]perhydroazine-2,6-dione), in the treatment of uncomplicated forms of influenza and other ARVI in adults.

Materials and methods. The phase III clinical trial enrolled 260 people aged 18–65 years with mild and moderate forms of influenza or other ARVI. Patients were randomly assigned to two groups: in group 1 (n=130), patients were prescribed the drug Aterixen® in tablets of 100 mg 2 times a day for 5 days; in group 2 (n=130) – a placebo corresponding to the drug, in the same regimen. The primary endpoint of the efficacy assessment was the time in hours from the first administration of the drug to clinical improvement. The main efficacy analysis was performed in a population of patients with PCR-confirmed influenza or ARVI who completed the study according to the protocol (per protocol infected). Additionally, efficacy was evaluated in ITT and PP populations, including patients with both identified and undetected pathogen. The population for safety analysis included all patients, without exception, who were exposed to at least one exposure to the study drug or placebo.

Results. A statistically significant superiority of the drug Aterixen® over placebo in primary endpoint was revealed in both the main and additional analysis in all studied populations: clinical improvement in the group of the studied drug occurred 24 hours faster compared with the placebo group. The evaluation of the effectiveness of secondary endpoints confirmed the superiority of the drug Aterixen® over placebo in terms of relief of catarrhal symptoms and symptoms of intoxication. A favorable safety profile of the drug has been demonstrated.

Conclusion. The drug has demonstrated a favorable safety profile for use in outpatient practice. Aterixen® is an effective and safe treatment for influenza and other ARVI in adults.

About the authors

Andrey G. Malyavin

Russian University of Medicine

Email: maliavin@mail.ru
ORCID iD: 0000-0002-6128-5914

д-р мед. наук, проф. каф. фтизиатрии и пульмонологии лечебного фак-та 

Russian Federation, Moscow

Madina I. Bagaeva

Valenta Pharm Pharmaceutical Company JSC

Author for correspondence.
Email: madina.bagaeva@valentapharm.com
ORCID iD: 0000-0002-4577-1832

федеральный мед. советник 

Russian Federation, Moscow

Oleg V. Kalyuzhin

Sechenov First Moscow State Medical University (Sechenov University)

Email: kalyuzhin@list.ru
ORCID iD: 0000-0003-3628-2436

д-р мед. наук, проф., проф. каф. клинической иммунологии и аллергологии Института клинической медицины им. Н. В. Склифосовского 

Russian Federation, Moscow

References

  1. Острые респираторные вирусные инфекции (ОРВИ) у взрослых. Клинические рекомендации РФ. 2021. Режим доступа: Рубрикатор КР (minzdrav.gov.ru). Ссылка активна на 11.12.2023 [Ostrye respiratornye virusnye infektsii (ORVI) u vzroslykh. Klinicheskie rekomendatsii RF. 2021. Available at: Рубрикатор КР (minzdrav.gov.ru). Accessed: 11.12.2023 (in Russian)].
  2. Грипп у взрослых. Клинические рекомендации РФ. 2022. Режим доступа: Рубрикатор КР (minzdrav.gov.ru). Ссылка активна на 11.12.2023 [Gripp u vzroslykh. Klinicheskie rekomendatsii RF. 2022. Available at: Рубрикатор КР (minzdrav.gov.ru). Accessed: 11.12.2023(in Russian)].
  3. Globenko AA, Kuzin GV, Rydlovskaya AV, et al. Curtailing virus-induced inflammation in respiratory infections: emerging strategies for therapeutic interventions. Front Pharmacol. 2023;14:1087850. doi: 10.3389/fphar.2023.1087850
  4. Стукова М.А., Рыдловская А.В., Проскурина О.В., и др. Фармакодинамическая активность нового соединения XC221GI в in vitro и in vivo моделях вирусного воспаления респираторного тракта. MIR J. 2022;9(1):56-70 [Stukova MA, Rydlovskaya AV, Proskurina OV, et al. In vitro and in vivo pharmacodynamic activity of the new compound XC221GI in models of the viral inflammation of the respiratory tract. MIR J. 2022;9(1):56-70 (in Russian)]. doi: 10.18527/2500-2236-2022-9-1-56-70
  5. Singh L, Bajaj S, Gadewar M, et al. Modulation of Host Immune Response Is an Alternative Strategy to Combat SARS-CoV-2 Pathogenesis. Front Immunol. 2021;12:660632. doi: 10.3389/fimmu.2021.660632
  6. Latreille E, Lee WL. Modulation of the Host Response as a Therapeutic Strategy in Severe Lung Infections. Viruses. 2023;15(7):1462. doi: 10.3390/v15071462
  7. Zhou A, Zhang W, Dong X, et al. The battle for autophagy between host and influenza A virus. Virulence. 2022;13(1):46-59. doi: 10.1080/21505594.2021.2014680
  8. Калюжин О.В., Баранова А., Багаева М. И. Стратегия управления вирус-индуцированным воспалением при COVID-19. Результаты многоцентрового адаптивного рандомизированного двойного слепого плацебо-контролируемого исследования у амбулаторных пациентов. Инфекционные болезни. 2023;21(1):26-34 [Kalyuzhin OV, Baranova A, Bagaeva MI. Management strategy for virus-induced inflammation in COVID-19. Results of a multicenter, adaptive, randomized, double-blind, placebo-controlled study in outpatients. Infectious Diseases. 2023;21(1):26-34 (in Russian)]. doi: 10.20953/1729-9225-2023-1-26-34
  9. Горелов А.В., Калюжин О. В., Багаева М. И. Новые возможности упреждающей противовоспалительной терапии пациентов со среднетяжелой и тяжелой формой COVID-19. Терапевтический архив. 2022;94(7):872-5 [Gorelov AV, Kalyuzhin OV, Bagaeva MI. New opportunities for preventive anti-inflammatory therapy in the management of patients with moderate and severe COVID-19. Terapevticheskii Arkhiv (Ter. Arkh.). 2022;94(7):872-5 (in Russian)]. doi: 10.26442/00403660.2022.07.201729
  10. Jefferson T, Jones MA, Doshi P, et al. Neuraminidase inhibitors for preventing and treating influenza in adults and children. Cochrane Database Syst Rev. 2014;2014(4): CD008965. doi: 10.1002/14651858.CD008965.pub4
  11. Пшеничная Н.Ю., Булгакова В. А., Львов Н. И., и др. Клиническая эффективность умифеновира при гриппе и ОРВИ (исследование АРБИТР). Терапевтический архив. 2019;91(3):56-63 [Pshenichnaya NYu, Bulgakova VA, Lvov NI, et al. Clinical efficacy of umifenovir in influenza and ARVI (study ARBITR). Terapevticheskii Arkhiv (Ter. Arkh.). 2019;91(3):56-63 (in Russian)]. doi: 10.26442/00403660.2019.03.000127
  12. Taieb V, Ikeoka H, Ma FF, et al. A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influenza in otherwise healthy patients. Curr Med Res Opin. 2019;35(8):1355-64. doi: 10.1080/03007995.2019.1584505
  13. Faraone I, Labanca F, Ponticelli M, at all. Recent Clinical and Preclinical Studies of Hydroxychloroquine on RNA Viruses and Chronic Diseases: A Systematic Review. Molecules. 2020;25(22):5318. doi: 10.3390/molecules25225318
  14. Sukhatme VP, Reiersen AM, Vayttaden SJ, Sukhatme VV. Fluvoxamine: A Review of Its Mechanism of Action and Its Role in COVID-19. Front Pharmacol. 2021;12:652688. doi: 10.3389/fphar.2021.652688

Supplementary files

Supplementary Files
Action
1. JATS XML
Download
2. Fig. 1. Graphic schedule of the study.

Download (86KB)
Indexing metadata
3. Fig. 2. Change of body temperature (°C) in patients with influenza or other acute respiratory viral infections in the Aterixen® and placebo groups (mean ± standard error).

Download (90KB)
Indexing metadata

Copyright (c) 2023 Consilium Medicum

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
 
 


This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies