clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.37489/2588-0519-GCP-0010UDKQFWclinvest-839Research ArticleКЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯCLINICAL PHARMACOLOGYМесто препаратов из группы моноклональных антител  в профилактике инфицирования вирусом ковид-19  и роль в терапии пациентов с осложнёнными формами инфекционного заболевания: обзор литературыT he role of monoclonal antibody drugs in the prevention of COVID-19 infection and their role in the treatment of patients with complicated forms of the infectious disease: a literature reviewhttps://orcid.org/0009-0009-2612-913XВарданянА. Г.VardanyanA. G.

Варданян Аргишти Гагикович — ассистент кафедры клинической фармакологии им. Ю. Б. Белоусова ИКМ

Москва

Argishti G. Vardanyan — assistant, Department of Clinical Pharmacology named after Yu. B. Belousov

Moscow

argisht@mail.ruhttps://orcid.org/0000-0003-4259-0945ТепловаН. В.TeplovaN. V.

Теплова Наталья Вадимовна — д. м. н., профессор, зав. кафедрой клинической фармакологии им. Ю. Б. Белоусова ИКМ

Москва

Natalia V. Teplova — Dr. Sci. (Med.), professor, Head of the Department of Clinical Pharmacology named after Yu. B. Belousov

Moscow

teplova.nv@yandex.ruЕвсиковЕ. М.EvsikovE. M.

Евсиков Евгений Михайлович — д. м. н., профессор кафедры клинической фармакологии им. Ю. Б. Белоусова ИКМ 

Москва

Evgeny M. Evsikov — Dr. Sci. (Med.), professor, Department of Clinical Pharmacology named after Yu. B. Belousov

Moscow

dr.Evsikov@gmail.comhttps://orcid.org/0009-0004-9143-0993ЧобанянМ. А.ChobanyanM. A.

Чобанян Маргарита Артуровна — аспирант кафедры клинической фармакологии имени Ю. Б. Белоусова ИКМ 

Москва

Margarita A. Chobanyan — Postgraduate Student, Department of Clinical Pharmacology named after Yu. B. Belousov

Moscow

margarita.chobanyan@gmail.comhttps://orcid.org/0009-0007-9130-3267БелоусоваЛ. Б.BelousovaL. B.

Белоусова Людмила Борисовна — лаборант, кафедра клинической фармакологии имени Ю. Б. Белоусова ИКМ

Москва

Ludmila B. Belousova — laboratory assistant, Department of Clinical Pharmacology named after Yu. B. Belousov

Moscow

lubelousova@mail.ruФГАОУ  ВО  «Российский  национальный  исследовательский  медицинский  университет  им.  Н. И. Пирогова»РоссияPirogov Russian National Research Medical UniversityRussian FederationФГАОУ  ВО  «Российский  национальный  исследовательский  медицинский  университет  им. Н. И. Пирогова»РоссияPirogov Russian National Research Medical UniversityRussian FederationФГАОУ  ВО  «Российский  национальный  исследовательский  медицинский  университет  им.  Н. И. Пирогова»РоссияPirogov Russian National Research Medical UniversityRussian FederationФГАОУ  ВО  «Российский  национальный  исследовательский  медицинский  университет  им.  Н. И. Пирогова»РоссияPirogov Russian National Research Medical UniversityRussian FederationФГАОУ  ВО  «Российский  национальный  исследовательский  медицинский  университет  им.  Н. И. Пирогова»РоссияPirogov Russian National Research Medical UniversityRussian Federation20263003202601416Copyright © Варданян А.Г., Теплова Н.В., Евсиков Е.М., Чобанян М.А., Белоусова Л.Б., 20262026Варданян А.Г., Теплова Н.В., Евсиков Е.М., Чобанян М.А., Белоусова Л.Б.Vardanyan A.G., Teplova N.V., Evsikov E.M., Chobanyan M.A., Belousova L.B.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/839Актуальность

Актуальность. Глобальная пандемия COVID-19 стимулировала интенсивную разработку новых методов иммунопрофилактики и терапии, среди которых особое место занимают моноклональные антитела (мАТ), нейтрализующие вирус SARS-CoV-2.

Цель

Цель. Определить место и терапевтическую ценность препаратов на основе моноклональных антител для профилактики инфицирования и лечения пациентов с COVID-19, включая осложнённые формы заболевания.

Основные положения

Основные положения. В обзоре представлены иммунологические основы создания мАТ, нацеленных преимущественно на спайковый (S) белок вируса, в частности на домен связывания с рецептором АПФ2. Проанализированы результаты ключевых доклинических исследований и международных рандомизированных клинических исследований (BLAZE-1, REGEN-COV, PROVENT, TACKLE) таких препаратов, как бамланивимаб/этесевимаб, касиривимаб/имдевимаб, тиксагевимаб/цилгавимаб. Показано, что применение мАТ, особенно в виде комбинированных коктейлей, у амбулаторных пациентов из групп высокого риска приводит к достоверному снижению вирусной нагрузки, сокращению частоты госпитализаций, прогрессирования в тяжёлые формы и смертности. Обсуждаются вопросы безопасности, эффективности против новых вариантов вируса и перспективы интеграции мАТ в клиническую практику.

Заключение

Заключение. Препараты моноклональных антител представляют собой эффективный инструмент для профилактики и раннего лечения COVID-19, демонстрируя значимую клиническую пользу у уязвимых групп пациентов.

Relevance

Relevance. The global COVID-19 pandemic has spurred the intensive development of new immunoprophylaxis and treatment methods, among which monoclonal antibodies (mAbs) neutralizing the SARS-CoV-2 virus hold a special place.

Objective

Objective. To determine the place and therapeutic value of monoclonal antibody-based drugs for the prevention of infection and treatment of patients with COVID-19, including complicated forms of the disease.

Main points

Main points. The review presents the immunological rationale for developing mAbs targeting primarily the viral spike (S) protein, specifically the receptor-binding domain (RBD) interacting with ACE2. The results of key preclinical studies and international randomized clinical trials (BLAZE-1, REGEN-COV, PROVENT, TACKLE) of drugs such as bamlanivimab/etesevimab, casirivimab/imdevimab, tixagevimab/cilgavimab are analyzed. It is shown that the use of mAbs, especially as combined cocktails, in high-risk outpatients leads to a significant reduction in viral load, hospitalization rates, progression to severe forms, and mortality. Issues of safety, efficacy against new viral variants, and prospects for integrating mAbs into clinical practice are discussed.

Conclusion

Conclusion. Monoclonal antibody drugs represent an effective tool for the prevention and early treatment of COVID-19, demonstrating significant clinical benefit in vulnerable patient groups.

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The authors declare that there are no conflicts of interest present.