[Pharmacoeconomic evaluation of the tixagevimab and cilgavimab combination using for pre-exposure prophylaxis of COVID-19].

AIM: To evaluate pharmacoeconomic feasibility using of the tixagevimab and cilgavimab combination for pre-exposure prophylaxis of COVID-19 in immunocompromised patients. MATERIALS AND METHODS: Cost-effectiveness of tixagevimab and cilgavimab in persons ≥12 years old who weigh ≥40 kg and have either a history of allergy that prevents their vaccination against COVID-19 or moderate or immunocompromised was assessed based on PROVENT phase III study results. The quantity of life years or quality-adjusted life years gained was calculated. Direct medical cost associated with prophylaxis of COVID-19, treatment of infected patients and those experiencing long COVID post infection were assessed. Results were compared with wiliness-to-pay threshold, measured as tripled gross domestic product per capita and equal to 2.69 mln RUB in 2022. RESULTS: Pre-exposure prophylaxis of COVID-19 results in additional 0.0287 life years or 0.0247 quality-adjusted life years. The cost of additional life year gained is equal to 1.12 mln RUB, the cost of additional quality-adjusted life years is 1.30 mln RUB. Both costs of additional life year and cost of quality-adjusted life years appeared to be significantly less compared to wiliness-to-pay threshold. CONCLUSION: Pre-exposure prophylaxis of COVID-19 with combination of tixagevimab and cilgavimab is economically feasible and may be recommended for wide use in Russian healthcare system.

Evaluation of clinical outcomes of COVID-19 in patients taking remdesivir in complex therapy in routine clinical practice

Remdesivir (GS-5734) is a new direct-acting antiviral drug in the nucleotide analogue class with antiviral activity against SARS-CoV-2 and the ability to inhibit RNA-dependent RNA polymerase. Preliminary results from phase III randomized clinical trials of remdesivir are inconsistent. Understanding the fact of the limited world experience with the use of remdesivir in COVID-19 required further study of its efficacy and safety in real clinical practice. The aim of the study is to evaluate the efficacy and safety of remdesivir in the treatment of patients with COVID-19. Material and methods. The study included 1422 patients with a novel coronavirus infection (COVID-19) who received remdesivir as part of complex therapy in a hospital setting at medical organizations of the Moscow public health system. Additionally, standard therapy was carried out, regulated by the Interim Guidelines "Prevention, Diagnosis and Treatment of Novel Coronavirus Infection (COVID-19)" of the Ministry of Healthcare of the Russian Federation, the current version. The efficacy of the drug was assessed based on primary and secondary efficacy points. Primary variable: 1) cumulative incidence of clinical outcomes in patients with COVID-19 treated with remdesivir as part of complex therapy;2) median time to clinical improvement according to the World Health Organization ordinal categorical scale (under clinical improvement, the patient is assumed to move >2 categories towards improvement in clinical condition). Secondary variables: 1) median time to achieve <2 NEWS scores lasting at least 24 hours or hospital discharge;2) mortality from all causes;3) duration of fever (>38 degreeC), days;4) duration of hospitalization, days;5) time to achieve elimination of the pathogen from the upper respiratory tract (no SARS-CoV-2 RNA), days. The safety of remdesivir was assessed based on the registration of adverse events using the method of spontaneous reports. Results. The analysis of clinical outcomes of treatment showed that 1195 (84.1%) patients recovered, death from all causes occurred in 227 (15.9%) patients. The median improvement in clinical status on the World Health Organization ordinal categorical scale was 6 days. The median time to reach a NEWS score of <2, lasting at least 24 hours, or hospital discharge was 4 days. The median duration of fever was 3 days from the start of remdesivir administration. The median length of hospital stays for patients included in the Register was 9 days. Adverse reactions associated with the use of remdesivir were recorded in 11 (0.7%) patients. Serious adverse reactions were not registered. During hospitalization, all adverse reactions were resolved. Conclusion. A retrospective analysis of data from the Registry of 1422 patients with COVID-19 who received remdesivir as part of complex therapy in medical organizations of the state healthcare system of Moscow in routine clinical practice showed clinical efficacy and a favorable safety profile of remdesivir (Remdeform, lyophilizate for solution for intravenous administration 100 mg, manufactured by JSC Pharmasyntez, Russia). The data obtained are consistent with previous randomized clinical trials of remdesivir and allow us to recommend its further use in patients with COVID-19 as part of complex therapy.Copyright © The Author(s), 2022.

[FEATURES OF THE USE OF ANTIBACTERIAL DRUGS IN PATIENTS WITH COVID-19].

The review traces the evolution of the section on the use of antibacterial drugs in the temporary guidelines of the Ministry of Health for the treatment of a new coronavirus infection. Diagnostic approaches that play an important role in deciding on the need and duration of antibacterial therapy are presented. Routine use of fluoroquinolones should be restricted due to the adverse safety spectrum. According to existing data, the tactic of short courses of antibacterial therapy for community-acquired pneumonia are not inferior in effectiveness to longer courses. Unjustified prescribing of antibiotics increases the cost of medical care, promotes the selection of resistant pathogens and leads to adverse side effects. Timely updating of clinical recommendations, implementation of programs to control the appointment of antibacterial agents in medical organizations and strengthening the role of the clinical pharmacology service can reduce these adverse events.

[Experience of anticipatory therapy with IL-6 receptor inhibitors and perspectives for its use in the evolution of COVID-19].

The Advisory Board chaired by the chief specialist in infectious diseases of the Ministry of Health of Russian Federation, Professor V.P. Chulanov was held on June 18, 2022 in Saint Petersburg. Aim. The main purpose of the Board was following discussion: the analysis of the real-world data of levilimab as an anticipatory therapy for COVID-19 in hospitalized patients; the review of the experience and perspectives of levilimab as an anticipatory anti-inflammatory option for outpatient patients who meet defined clinical and laboratory criteria. Results. The analyzed data on clinical efficacy and safety formed the basis of recommendations proposed by experts for the use of levilimab in the inpatient and outpatient medical care for COVID-19.

Changes in Post-COVID Syndrome Manifestations and Bulbar Conjunctival Angioscopy Results in a Patient Undergoing Treatment after Mild COVID-19

Microcirculation dysfunction plays a significant role in the development of post-COVID syndrome caused by SARS-CoV-2. However, there have been no studies on changes in microcirculation parameters during pharmacotherapy in patients with post-COVID syndrome. To date, there are no consensus recommendations for the treatment of post-COVID syndrome in the Russian Federation. The aim of the study was to analyse the pattern of clinical manifestations of post-COVID syndrome and bulbar conjunctival angioscopy (BCA) results in a young patient undergoing treatment after mild COVID-19. Materials and methods: analysis of the clinical case of a patient who was followed up at the Therapeutic Ophthalmology Centre between February and September 2021. BCA was performed in a patient with post-COVID syndrome to compare quantitative and qualitative microcirculation parameters before and after the treatment. Results: the paper summarises clinical observation data on a 23-year-old female patient with post-COVID syndrome with mainly neuropsychiatric manifestations and a microcirculation dysfunction as determined by BCA. The patient received pharmacotherapy with meldonium, ethylmethylhydroxypyridine succinate, and meglumine sodium succinate. Conclusions: the prescribed pharmacotherapy led to a significant improvement in the patient's condition (regression in neuropsychiatric symptoms) with simultaneous improvement of morphological and functional parameters assessed by BCA, which indicates an improvement in microcirculation processes and supports their role in post-COVID syndrome development. The obtained data suggest that the clinical picture of post-COVID syndrome is directly related to the severity of microcirculation dysfunction in various organs and tissues, and that BCA can be used for diagnosis and assessment of the syndrome's severity, as well as for assessment of the treatment's efficacy and safety.

Evaluation of clinical outcomes of COVID-19 in patients taking remdesivir in complex therapy in routine clinical practice

Remdesivir (GS-5734) is a new direct-acting antiviral drug in the nucleotide analogue class with antiviral activity against SARS-CoV-2 and the ability to inhibit RNA-dependent RNA polymerase. Preliminary results from phase III randomized clinical trials of remdesivir are inconsistent. Understanding the fact of the limited world experience with the use of remdesivir in COVID-19 required further study of its efficacy and safety in real clinical practice. The aim of the study is to evaluate the efficacy and safety of remdesivir in the treatment of patients with COVID-19. Material and methods. The study included 1422 patients with a novel coronavirus infection (COVID-19) who received remdesivir as part of complex therapy in a hospital setting at medical organizations of the Moscow public health system. Additionally, standard therapy was carried out, regulated by the Interim Guidelines “Prevention, Diagnosis and Treatment of Novel Coronavirus Infection (COVID-19)” of the Ministry of Healthcare of the Russian Federation, the current version. The efficacy of the drug was assessed based on primary and secondary efficacy points. Primary variable: 1) cumulative incidence of clinical outcomes in patients with COVID-19 treated with remdesivir as part of complex therapy;2) median time to clinical improvement according to the World Health Organization ordinal categorical scale (under clinical improvement, the patient is assumed to move >2 categories towards improvement in clinical condition). Secondary variables: 1) median time to achieve <2 NEWS scores lasting at least 24 hours or hospital discharge;2) mortality from all causes;3) duration of fever (>38 °C), days;4) duration of hospitalization, days;5) time to achieve elimination of the pathogen from the upper respiratory tract (no SARS-CoV-2 RNA), days. The safety of remdesivir was assessed based on the registration of adverse events using the method of spontaneous reports. Results. The analysis of clinical outcomes of treatment showed that 1195 (84.1%) patients recovered, death from all causes occurred in 227 (15.9%) patients. The median improvement in clinical status on the World Health Organization ordinal categorical scale was 6 days. The median time to reach a NEWS score of <2, lasting at least 24 hours, or hospital discharge was 4 days. The median duration of fever was 3 days from the start of remdesivir administration. The median length of hospital stays for patients included in the Register was 9 days. Adverse reactions associated with the use of remdesivir were recorded in 11 (0.7%) patients. Serious adverse reactions were not registered. During hospitalization, all adverse reactions were resolved. Conclusion. A retrospective analysis of data from the Registry of 1422 patients with COVID-19 who received remdesivir as part of complex therapy in medical organizations of the state healthcare system of Moscow in routine clinical practice showed clinical efficacy and a favorable safety profile of remdesivir (Remdeform®, lyophilizate for solution for intravenous administration 100 mg, manufactured by JSC Pharmasyntez, Russia). The data obtained are consistent with previous randomized clinical trials of remdesivir and allow us to recommend its further use in patients with COVID-19 as part of complex therapy. © The Author(s), 2022.

Hydroxychloroquine: The story of one drug during the COVID-19 pandemic

The new coronavirus (SARS-CoV-2) poses a serious threat to public health worldwide. From the moment of its finding to the present, the incidence of new cases is only increasing. So far, no drugs were proven to have antiviral activity in clinical practice. Many drugs have already gone a path from in vitro studies to randomized clinical trials in vivo. Objective. To review the literature on the use of hydroxychloroquine for the prevention and treatment of new coronavirus infection (COVID-19) for the period from the date of use until June 2020. © 2020, Media Sphera Publishing Group. All rights reserved.