Efficacy and safety of etiotropic antiviral therapy in COVID‑19 in outpatient patients

Чухляев, Павел; Janibekov, J. J.; Хавкина, Д. А.; Руженцова, Т. А.

doi:10.33667/2078-5631-2022-18-23-26

Cited by 3 publications

(2 citation statements)

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“…Терапевтическая тактика, включающая только симп томатическое и патогенетическое лечение без противовирусных средств, существенно менее эффективна, приводит к более длительному течению заболевания, ухудшению клинического статуса пациента, увеличению риска неблагоприятных исходов. Полученные в Республике Каракалпакстан данные, в целом, сходны с ранее опубликованными данными, полученными по результатам исследований в других странах, и подтверждают эффективность противовирусной терапии при COVID-19 [2,4,11]. Однако, в отличие от них, нами проведен анализ влияния предшествующей терапии, полученной пациентами до момента госпитализации.…”

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“…Однако при отсутствии результатов лабораторной диагностики на наличие SARS-CoV-2 применение этого препарата в амбулаторных условиях у пациентов с нетяжелым течением вполне допустимо. Вместе с тем, нельзя не учитывать и выводы проведенных ранее исследований, под-твердивших его эффективность [11,13]. В то же время при сравнении эффективности умифеновира и фавипиравира были получены сопоставимые данные [14]…”

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The importance of outpatient etiotropic therapy in patients hospitalized with COVID-19

Zhanibekov¹,

Чухляев

Хавкина

et al. 2023

jour

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The aim of the study was to evaluate the effect of antiviral therapy prescribed at the outpatient stage on the course and outcomes of COVID-19 in hospitalized patients.Materials and methods. The retrospective study included 182 hospitalized patients with COVID-19 of moderate severity who received various initial therapy in the period before hospitalization. In the main group (91 patients), therapy included antiviral drugs: favipiravir or umifenovir, in the comparison group (also 91 patients), the treatment regimens did not contain etiotropic drugs against SARS-CoV-2.The groups were comparable in age, gender and severity of the disease. All patients received antipyretic drugs (paracetamol), vitamin therapy, according to indications -local antiseptics, mucolytics, antiplatelet agents and antibacterial drugs. The effectiveness of treatment was evaluated on days 7 and 14.Results. The presence of the virus was significantly less frequently detected on day 7 -in 15.38% and on day 14 of the disease -in 2.20% among patients receiving antiviral therapy, 82.42% and 39.56%, respectively in the comparison group. The average duration of the disease was more than 5 days less -8.28 ± 3.74 days. The proportion of patients with a deterioration in their clinical condition to 3-4 points was significantly higher in the group that did not receive antiviral drugs -61.54%, and with the use of favipiravir or umifenovir -2.2%.Conclusions:1. Timely administration of antiviral therapy for COVID-19 at the outpatient stage prevents the increase in severity, the development of complications, promotes earlier elimination of the virus and shortens the duration of the disease during hospitalization of the patient.2. The absence of antiviral therapy with moderate severity of COVID-19 at the outpatient stage significantly increases the risk of deterioration of the patient's condition.

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The importance of outpatient etiotropic therapy in patients hospitalized with COVID-19

Zhanibekov¹,

Чухляев

Хавкина

et al. 2023

jour

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Phase I Pharmacokinetics Study of Drug for Infusion «Areplivir» (INN: Favipiravir) (LLC "PROMOMED RUS", Russia)

Komarov,

Bagaeva,

Karnakova

et al. 2023

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. The novel coronavirus infection COVID-19 (Coronavirus Disease 2019) is caused by an enveloped, positive-sense, single-stranded ribonucleic acid (RNA) virus SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus 2). Favipiravir is the antiviral drug recommended for etiotropic treatment of COVID-19. Parenteral therapy has advantages over the other routes of the drug administration: there are no interaction with food and digestive enzymes, may be used for patients with diseases of the digestive system and unconscious patients. For parenteral drug administration of favipiravir the drug "Areplivir" has been registered in Russia.Aim. The aim is pharmacokinetics study of drug "Areplivir", a lyophilisate for the preparation of a concentrate for the infusion solution (the manufacturer is JSC "Biokhimic", LLC "Promomed RUS" as registration certificate holder) by intravenous infusion in healthy volunteers in a phase I pharmacokinetics study.Materials and methods. The clinical and analytical phases of the pharmacokinetic study as well as pharmacokinetic analyses have been performed as part of a clinical trial of the drug "Areplivir" in different doses, a lyophilisate for the preparation of a concentrate for the infusion solution (LLC "Promomed RUS", Russia). Chromatographic separation and detection were carried out on a LC-2040C high-performance liquid chromatograph (Shimadzu Corporation, Japan) with a built-in UV detector, a low-pressure four-component gradient pump, a degasser, an autosampler, a column thermostat and a controller. The pharmacokinetic parameters were calculated with the Boomer pharmacokinetic analysis add-in for Microsoft Excel (Department of Pharmacokinetics and Drug Metabolism, Allergan, Irvine, CA 92606, USA). Descriptive pharmacokinetic statistics were calculated with Microsoft Excel (Microsoft Corporation, USA). Correlation and Regression Analysis were conducted with IBM SPSS Statistics (version 23.0), IBM, USA.Results and discussion. For single dose administration of 400, 800, 1600 and 1800 mg in 4 cohorts of 5 volunteers pharmacokinetic parameters were calculated. For Cmax and an administered dose the strong correlation coefficient on the Chaddock scale (r = 0,98; p = 0,02; r – Pearson correlation coefficient; p – the reached significance value) and the determination coefficient (R2 = 0,96; F = 45,97; p = 0,02; R2 – determination coefficient; F – the actual value of the Fisher's criterion) were statistically significant. For AUC0-t and an administered dose the strong correlation coefficient on the Chaddock scale (r = 0,97; p = 0,03) and the determination coefficient (R2 = 0,94; F = 33,54; p = 0,03) were statistically significant. The obtained results show the linearity of Cmax and an administered dose and the linearity of AUC0-t and an administered dose (400–1800 mg).Conclusion. According to the concentrations of favipiravir from the analytical phase of the pharmacokinetic study the pharmacokinetic parameters were calculated, averaged pharmacokinetic profiles in linear and log-linear scales were plotted after single dose administrations of the drug "Areplivir" in different doses, a lyophilisate for the preparation of a concentrate for the infusion solution (LLC "Promomed RUS", Russia). The linearity of Cmax and a single administered dose and the linearity of AUC0-t and a single administered dose of the drug "Areplivir" have been demonstrated for doses of 400 to 1800 mg. The results justified the study of multiple dose administration of "AREPLIVIR" and the subsequent phases of clinical trials.

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Efficacy and safety of oral antiviral therapy medications in the treatment of moderate and severe cases of COVID-19. Results of a comparative retrospective observational study

Sabitov,

Tikhonova,

Esaulenko

et al. 2024

A&Ch

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Цель. Провести сравнение клинической эффективности и безопасности двух противовирусных препаратов, подавляющих репликацию вирусов (ингибиторы вирусной РНК-полимеразы), при лечении больных с COVID-19: фавипиравира и риамиловира. Материал и методы. Клиническую эффективность и безопасность оценивали на основании ретроспективного исследования 1071 пациента, в том числе получавших фавипиравир 561 человек, риамиловир -510 человек. Результаты. Среди пациентов, получавших риамиловир, зафиксировано статистически достоверное сокращение длительности симптомов и среднего койко-дня как при среднетяжёлой, так и при тяжёлой форме болезни по сравнению с группой, принимавших фавипиравир. На фоне приёма риамиловира быстрее снижались маркеры воспаления (СРБ, фибриноген). Заключение. Риамиловир продемонстрировал более высокий уровень клинической эффективности и безопасности при лечении COVID-19 по сравнению с фавипиравиром.

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Efficacy and safety of etiotropic antiviral therapy in COVID‑19 in outpatient patients

Cited by 3 publications

References 5 publications

The importance of outpatient etiotropic therapy in patients hospitalized with COVID-19

The importance of outpatient etiotropic therapy in patients hospitalized with COVID-19

Phase I Pharmacokinetics Study of Drug for Infusion «Areplivir» (INN: Favipiravir) (LLC "PROMOMED RUS", Russia)

Efficacy and safety of oral antiviral therapy medications in the treatment of moderate and severe cases of COVID-19. Results of a comparative retrospective observational study

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