New possibilities for targeted antiviral therapy for COVID-19. Results of a multi center clinical study of the efficacy and safety of using the drug Areplivir

Abstract

The article presents the results of a clinical study of the efficacy and safety of etiotropic therapy in patients hospitalized with a new coronavirus infection caused by the SARS-CoV-2 virus.

The aim - to study the efficacy and safety of favipiravir (Areplivir) in patients with novel coronavirus infection (COVID-19) in comparison with the recommended standard therapy.

Material and methods. 200 men and women with COVID-19 between the ages of 18 and 80 were randomized in the study. The main group consisted of patients receiving treatment with favipiravir, in the comparison group, patients were prescribed etiotropic therapy in accordance with the current version of the Temporary guidelines of the Ministry of Health of Russia "Prevention, diagnosis and treatment of coronavirus infection (COVID-19)". The efficacy and safety of therapy was determined based on the assessment of clinical improvement according to the WHO Categorical Scale of Clinical Improvement, clinical and laboratory data, the results of CT scan of the chest organs and the clearance of the SARS-CoV-2 virus. The frequency and nature of the occurrence of adverse events, the need for invasive and non-invasive oxygen support, and the frequency of deaths were also evaluated.

Results. The performed comparative analysis demonstrated a significant advantage of favipiravir therapy compared with standard therapy in terms of the rate of improvement in clinical status (on average by 4 days), the speed and frequency of recovery on the 10th day of therapy (no clinical signs of the disease in the study and control groups were observed in 44 and 10% of patients, respectively), the frequency of achieving the viral clearance on the 10th day of therapy (98 and 78% in the study and control groups, respectively) (p=0.00003). Favipiravir therapy was accompanied by a significant improvement in lung condition according to CT data, improved laboratory parameters and normalization of oxygen saturation levels. Favipiravir therapy was characterized by a favorable safety profile. In the main group, no aggravation of the course of the disease or serious adverse events related to the drug were recorded.

Conclusions. The use of favipiravir for the treatment of infection caused by the SARS-CoV-2 can shorten the period before the onset of clinical improvement by an average of 4 days compared with standard therapy, improve the lung condition according to CT and the viral clearance in more than 90% patients, which contributes to a faster recovery. Favipiravir therapy is characterized by a favorable safety profile and good tolerability. The overall incidence of adverse events in the favipiravir group was comparable to that observed with standard therapy. The selected therapy regimen can be considered clinically justified, the course of therapy is necessary and sufficient to achieve the required therapy efficacy. Timely initiation of therapy with favipiravir (Areplivir) improves the prognosis of the disease and reduces the global socio-economic burden of the current pandemic.

Keywords:coronavirus, SARS-CoV-2, COVID-19, favipiravir, Areplivir

Conflict of interests. The authors declare that there is no conflict of interest.

Funding. The research was carried out at the initiative of the Promomed RUS company. The sponsor had no influence on the analysis and interpretation of the results.

Contribution: writing text - Balykova L.A., Pushkar D.Yu.; participation in the development of research and control over its conduct -Zaslavskaya K.Ya.; principal investigators responsible for recruitment of patients, study treatment, and data collection in compliance with the protocol - Balykova L.A., Simakina E.N., Agaf'ina A.S., Ivanova A.Yu., Kolontarev K.B., Pushkar D.Yu.; participation in the development of Areplivir, chose and analysis of materials for the article - Granovskaya M.V.; editing - Balykova L.A., Zaslavskaya K.Ya., Pushkar D.Yu.

For citation: Balykova L.A., Granovskaya M.V., Zaslavskaya K.Ya., Simakina E.N., Agaf'ina A.S., Ivanova A.Yu., Kolontarev K.B., Pushkar D.Yu. New possibilities for targeted antiviral therapy for COVID-19. Results of a multicenter clinical study of the efficacy and safety of using the drug Areplivir. Infektsionnye bolezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2020; 9 (3): 16-29. DOI: https://doi.org/10.33029/2305-3496-2020-9-3-16-29 (in Russian)

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CHIEF EDITOR
CHIEF EDITOR
Yushchuk Nikolay Dmitrievich
Academician of the Russian Academy of Sciences, Professor, head of the Infectious Diseases and Epidemiology Department, President of the Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Board member of the National Scientific Infectiologists? Society.

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