Comparative effectiveness of new pharmacotherapy regimens for mild COVID-19 based on symptom resolution dynamics

Keywords: COVID-19; Therapeutics; diagnosis; Pharmaceutical Preparations; Pharmacoeconomics, efficacy, clinical endpoint.

Abstract

the treatment of COVID-19 remains a challenging issue worldwide due to the huge economic losses to society as a result of the disease's widespread prevalence, peculiarities of its course and complications of its development. The purpose of the work was comparative analysis of the effectiveness of new treatment regimens for outpatients with mild COVID-19. 64 medical charts of outpatient diseases with a mild course of COVID-19 were studied. Depending on the treatment regimen used, all patients were divided into two groups that received inhaled ACEs or antiviral therapy with the combination drug nortrelvir/ritonavir. The efficacy of each pharmacotherapeutic alternative would be determined on the basis of retrospective data for the timeframe of normalisation of clinical and laboratory parameters. A rule was established that the set of all clinical and laboratory parameters in the normal range is considered as a clinical endpoint. It was found that the use of ACC treats the disease until the rapid disappearance of clinical symptoms, especially in the first treatment, which works on its rapid therapeutic effect in the initial stages. Nirmatrelvir/ritonavir has also been shown to be effective in reducing symptoms, but its effect is incremental, reaching full relief slightly later than in ACC. Modeling of the dynamics of reaching the clinical point of elimination of all clinical symptoms indicates a pharmacoeconomic advantage of the use of ACC over nirmatrelvir/ritonavir, if the additional costs of treatment do not exceed the cost of three days of treatment.

References

Дзюблик І. В., Трохименко О. П., Соловйов С. О., Гуменюк Г. Л., Дзюблик О. Я., Гуменюк Н. І., Яковенко О. К. Противірусна активність амінокапронової кислоти по відношенню до коронавірусу інфекційного бронхіту в умовах in vitro. Укр. пульмонол. журнал. 2021;29(4):35-39. doi:10.31215/2306-4927-2021-29-4-35-39

Оцінка медичних технологій: від теорії до практики математичного моделювання: навч. посіб. / С. О. Соловйов, Н. А. Білоусова, В. В. Трохимчук. Київ : КПІ ім. Ігоря Сікорського, Вид-во «Політехніка», 2024. 140 с.

Ang Q, Liu Z, Wang W, Li K. Explored research on data preprocessing and mining technology for clinical data applications. 2nd IEEE International Conference on Information Management and Engineering. IEEE, 2010.327-330. doi:10.1109/ICIME.2010.5477660

Beam Jr, T. R., Gilbert, D. N., & Kunin, C. M. (1990). Updated Guidelines for the Evaluation of New Anti-Infective Drug Products. Drug Information Journal. 1990;24(1):225-229. doi:10.1177/009286159002400134

Clinical management of COVID-19: Living guideline (7th version) URL: https://www.ncbi.nlm.nih.gov/books/NBK582435

Dziublyk, I. V., Soloviov, S. O., Trokhimenko, O. P., Dziublyk, O. Y., Smetiukh, M. P., Yakovenko, K., ... & Gumeniuk, M. I. In vitro study of the spectrum antiviral activity of aliphatic acid toward the prototype coronavirus strain. Biomedical and Biotechnology Research Journal (BBRJ).2023;7(2):218-224. doi:10.4103/bbrj.bbrj_36_23

Grigore, B., Ciani, O., Dams, F., Federici, C., de Groot, S., Möllenkamp, M., Rabbe, S., Shatrov, K., Zemplenyi, A., & Taylor, R. S. Surrogate Endpoints in Health Technology Assessment: An International Review of Methodological Guidelines. PharmacoEconomics.2020;38(10):1055–1070. doi:10.1007/s40273-020-00935-1

Huang, Y., Li, W., Macheret, F., Gabriel, R. A., & Ohno-Machado, L. A tutorial on calibration measurements and calibration models for clinical prediction models. Journal of the American Medical Informatics Association: JAMIA.2020;27(4):621–633. doi:10.1093/jamia/ocz228

Kelton, K., Klein, T., Murphy, D., Belger, M., Hille, E., McCollam, P. L., Spiro, T., & Burge, R. Cost-Effectiveness of Combination of Baricitinib and Remdesivir in Hospitalized Patients with COVID-19 in the United States: A Modelling Study. Advances in therapy.2022;39(1):562–582. doi:10.1007/s12325-021-01982-6

Oral COVID-19 antiviral, Paxlovid, approved by UK regulator (рress release). Medicines and Healthcare products Regulatory Agency. URL: https://www.gov.uk/government/news/oral-covid-19-antiviral-paxlovid-approved-by-uk-regulator

Paxlovid EPAR. European Medicines Agency (EMA). URL:https://www.ema.europa.eu/en/medicines/human/EPAR/paxlovid

Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment (рress release). URL: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-receives-us-fda-emergency-use-authorization-novel

Qaseem, A., Yost, J., Miller, M. C., Andrews, R., Jokela, J. A., Forciea, M. A., Abraham, G. M., Humphrey, L. L., Scientific Medical Policy Committee of the American College of Physicians, Lee, R. A., Tschanz, M. P., Etxeandia-Ikobaltzeta, I., Harrod, C., Shamliyan, T., & Umana, K. Outpatient Treatment of Confirmed COVID-19: Living, Rapid Practice Points From the American College of Physicians (Version 1). Annals of internal medicine.2023;176(1):115–124. doi:10.7326/M22-2249

Serkedjieva, J., Nikolova, E., & Kirilov, N. Synergistic inhibition of influenza A virus replication by a plant polyphenol-rich extract and epsilon-aminocaproic acid in vitro and in vivo. Acta virologica.2010;54(2):137–145. doi:10.4149/av_2010_02_137

Watson, O. J., Barnsley, G., Toor, J., Hogan, A. B., Winskill, P., & Ghani, A. C. (2022). Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. The Lancet. Infectious diseases.2022;22(9):1293–1302. doi:10.1016/S1473-3099(22)00320-6

Published
2024-09-30
How to Cite
1.
Surtaieva N, Yakovenko O, Soloviov S, Trokhymchuk V, Babenko M, Sukhin R, Kapitan G, Dziublyk O, Yachnyk V. Comparative effectiveness of new pharmacotherapy regimens for mild COVID-19 based on symptom resolution dynamics. USMYJ [Internet]. 2024Sep.30 [cited 2026Jul.12];149(3):166-74. Available from: https://mmj.nmuofficial.com/index.php/journal/article/view/443
Section
Pharmacy, industrial pharmacу