Experience of Using Remdesivir in Patients with Novel Coronavirus Infection.

Timely, effective, and safe antiviral therapy in COVID-19 patients reduces complications, disability and mortality rates. The greatest concern with remdesivir is the risk of drug-induced liver injury, including in patients whose liver function is compromised by COVID-19. The aim of the study was to investigate the efficacy and safety of remdesivir in patients with confirmed SARSCoV-2 infection who had been admitted to an infectious diseases hospital in the Volgograd region in March 2022. Material(s) and Method(s): the authors carried out an open, non-randomised, single-arm study using medical records of 234 patients who had been diagnosed with "U07.1 COVID-19, virus identified" and prescribed remdesivir upon admission. The effectiveness of therapy was evaluated using two criteria: the need for oxygen supplementation or ventilatory support, or mortality. The authors conducted the evaluation on days 7, 14, and 28 using the six-point ordinal severity scale by Y. Wang et al. The safety of therapy was assessed on the basis of complaints and changes in laboratory findings. Result(s): for the patients prescribed remdesivir at admission, the 7-day mortality rate was 3.0%, the 14-day mortality rate was 5.6%, and the 28-day mortality rate was 7.3%. With the exception of a patient with myocardial infarction, all the patients who had been hospitalised with mild COVID-19 and prescribed remdesivir did not require oxygen therapy and/or transfer to intensive care and were discharged following recovery. The patients with moderate to severe COVID-19 had the 14-day mortality rate of 6.4% and the 28-day mortality rate of 8.6%. 17 patients (7.2%) discontinued remdesivir prematurely for various reasons, including adverse drug reactions. Remdesivir therapy of 5-10 days was associated with an increase in ALT activity by 2.7 +/- 0.8 times in 15.9% of patients with mild COVID-19, by 3.8 +/- 1.8 times in 20.4% of patients with moderately severe COVID-19, and by 4.8 +/- 2.7 times in 24% (12/50) of patients with severe COVID-19. In two patients (0.9%), the increase exceeded 10-fold the upper limit of normal. Conclusion(s): the obtained results support recommending remdesivir to patients with mild, moderate and severe COVID-19, including those with moderately elevated baseline activity of hepatic transaminases.Copyright © NEICON ISP LLC. All rights reserved.

Experience of Using Remdesivir in Patients with Novel Coronavirus Infection.

Timely, effective, and safe antiviral therapy in COVID-19 patients reduces complications, disability and mortality rates. The greatest concern with remdesivir is the risk of drug-induced liver injury, including in patients whose liver function is compromised by COVID-19. The aim of the study was to investigate the efficacy and safety of remdesivir in patients with confirmed SARSCoV-2 infection who had been admitted to an infectious diseases hospital in the Volgograd region in March 2022. Material(s) and Method(s): the authors carried out an open, non-randomised, single-arm study using medical records of 234 patients who had been diagnosed with "U07.1 COVID-19, virus identified" and prescribed remdesivir upon admission. The effectiveness of therapy was evaluated using two criteria: the need for oxygen supplementation or ventilatory support, or mortality. The authors conducted the evaluation on days 7, 14, and 28 using the six-point ordinal severity scale by Y. Wang et al. The safety of therapy was assessed on the basis of complaints and changes in laboratory findings. Result(s): for the patients prescribed remdesivir at admission, the 7-day mortality rate was 3.0%, the 14-day mortality rate was 5.6%, and the 28-day mortality rate was 7.3%. With the exception of a patient with myocardial infarction, all the patients who had been hospitalised with mild COVID-19 and prescribed remdesivir did not require oxygen therapy and/or transfer to intensive care and were discharged following recovery. The patients with moderate to severe COVID-19 had the 14-day mortality rate of 6.4% and the 28-day mortality rate of 8.6%. 17 patients (7.2%) discontinued remdesivir prematurely for various reasons, including adverse drug reactions. Remdesivir therapy of 5-10 days was associated with an increase in ALT activity by 2.7 +/- 0.8 times in 15.9% of patients with mild COVID-19, by 3.8 +/- 1.8 times in 20.4% of patients with moderately severe COVID-19, and by 4.8 +/- 2.7 times in 24% (12/50) of patients with severe COVID-19. In two patients (0.9%), the increase exceeded 10-fold the upper limit of normal. Conclusion(s): the obtained results support recommending remdesivir to patients with mild, moderate and severe COVID-19, including those with moderately elevated baseline activity of hepatic transaminases.Copyright © NEICON ISP LLC. All rights reserved.

Experience of Using Remdesivir in Patients with Novel Coronavirus Infection

Timely, effective, and safe antiviral therapy in COVID-19 patients reduces complications, disability and mortality rates. The greatest concern with remdesivir is the risk of drug-induced liver injury, including in patients whose liver function is compromised by COVID-19. The aim of the study was to investigate the efficacy and safety of remdesivir in patients with confirmed SARSCoV-2 infection who had been admitted to an infectious diseases hospital in the Volgograd region in March 2022. Materials and methods: the authors carried out an open, non-randomised, single-arm study using medical records of 234 patients who had been diagnosed with "U07.1 COVID-19, virus identified” and prescribed remdesivir upon admission. The effectiveness of therapy was evaluated using two criteria: the need for oxygen supplementation or ventilatory support, or mortality. The authors conducted the evaluation on days 7, 14, and 28 using the six-point ordinal severity scale by Y. Wang et al. The safety of therapy was assessed on the basis of complaints and changes in laboratory findings. Results: for the patients prescribed remdesivir at admission, the 7-day mortality rate was 3.0%, the 14-day mortality rate was 5.6%, and the 28-day mortality rate was 7.3%. With the exception of a patient with myocardial infarction, all the patients who had been hospitalised with mild COVID-19 and prescribed remdesivir did not require oxygen therapy and/or transfer to intensive care and were discharged following recovery. The patients with moderate to severe COVID-19 had the 14-day mortality rate of 6.4% and the 28-day mortality rate of 8.6%. 17 patients (7.2%) discontinued remdesivir prematurely for various reasons, including adverse drug reactions. Remdesivir therapy of 5-10 days was associated with an increase in ALT activity by 2.7 ± 0.8 times in 15.9% of patients with mild COVID-19, by 3.8 ± 1.8 times in 20.4% of patients with moderately severe COVID-19, and by 4.8 ± 2.7 times in 24% (12/50) of patients with severe COVID-19. In two patients (0.9%), the increase exceeded 10-fold the upper limit of normal. Conclusions: the obtained results support recommending remdesivir to patients with mild, moderate and severe COVID-19, including those with moderately elevated baseline activity of hepatic transaminases.

Safety of Therapy with Tocilizumab and Other Interleukin Inhibitors

Monoclonal antibodies directed against interleukin and interleukin receptors have been successfully used for the treatment of rheumatic diseases since 2001, and since 2020 they have been used as part of complex therapy for patients with severe COVID-19. This raises the question of safety of these products, especially when used for new indications. The aim of the study was to analyse data on potential adverse reactions to tocilizumab and other interleukin inhibitors in order to increase the safety of pharmacotherapy of systemic connective tissue diseases, as well as of severe COVID-19. Literature data suggest that the most frequent adverse reactions to tocilizumab and other interleukin inhibitors are infections, hypercholesterolemia, leukopenia, neutropenia, thrombocytopenia, and increased liver enzyme activity. Hypersensitivity and acute infusion reactions, manifested as pseudoallergic reactions, also pose serious health risks and can even be fatal. However, the identification of undesirable reactions to interleukin inhibitors is challenging, due to their prolonged intake and long intervals between injections. Besides, they are often used in combination with other medicines, such as methotrexate or glucocorticosteroids, which complicates establishment of a reliable correlation between an adverse reaction and a particular medicine. At present, the safety of tocilizumab and other interleukin inhibitors for the treatment of severe COVID-19 has not been studied properly and needs further research with an increased number of participants and a careful analysis of the risk/benefit ratio of these medicines when used for COVID-19 treatment.

CLINICAL AND ECONOMIC ANALYSIS OF GENETICALLY ENGINEERED BIOLOGICS CONSUMPTION BY PATIENTS WITH COVID-19

The aim of the article is a comparative clinical and economic assessment of genetically engineered monoclonal antibodies against interleukins in infectious diseases facilities in Volgograd region, reassigned to treat COVID-19 patients. Materials and methods. ABC analysis of the drug consumption in infectious disease facilities in Volgograd region in 2020 and 2021, cost-minimization analysis, and volume of consumption (standard dose per 1000 patients) for genetically engineered monoclonal antibodies against interleukins, were performed on the basis of pharmacies dispensing drug reports on infectious diseases facilities, Russian State Register of maximum selling prices, and Russian guidelines for COVID-19 treatment. Results. Only a small proportion of COVID-19 patients (43.6 standard doses per 1000 patients in 2020 and 137.8 per 1000 patients in 2021) received genetically engineered biologics in infectious disease facilities in Volgograd Region. Nevertheless, in the studied facilities, medical drug expenses on them exceeded from 20% in 2020 to 40% of the total inventory value in 2021. In mild COVID-19 patients with a high comorbidity index, netaquimab was the least expensive drug therapy and levilimab was the most expensive one. For moderate COVID-19, a standart recommended dose of sarilumab was the least expensive among the drugs used in the studied facilities, and anakinra was the least expensive drug among all the recommended GEBs. In severe and extremely severe COVID-19 courses, tocilizumab and sarilumab were less the least expensive among the GEBs used in the infectious disease facilities, and anakinra was the least expensive among all the recommended GEBs. Conclusion. Accepting a possible equal effectiveness based on the currently available data, sarilumab is the least expensive for moderate COVID-19 and tocilizumab is the least expensive for severe and extremely severe COVID-19.