Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study.

Autor:	Burhan E; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Syahruddin E; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Isbaniah F; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Desianti GA; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Fachrucha F; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Sari CYI; Department of Pulmonology, Jakarta Islam Hospital Cempaka Putih, Jakarta, Indonesia., Ismail E; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia.; Department of Pulmonology, Yarsi Hospital, Jakarta, Indonesia., Astuti P; Department of Pulmonology, Cengkareng District General Hospital, Jakarta, Indonesia., Maruli MF; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Mubarak F; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Rengganis AT; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Bilqis HH; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Taslim I; Department of Pulmonology and Respiratory Medicine, Persahabatan Central General Hospital, Universitas Indonesia, Jakarta, Indonesia., Sastria E; General Practitioner, Yarsi Hospital, Jakarta, Indonesia., Wiyarta E; Department of Medical Science, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Jazyk:	angličtina
Zdroj:	Frontiers in pharmacology [Front Pharmacol] 2023 Jun 30; Vol. 14, pp. 1205238. Date of Electronic Publication: 2023 Jun 30 (Print Publication: 2023).
DOI:	10.3389/fphar.2023.1205238
Abstrakt:	Background: This study aimed to determine the real-world safety and effectiveness of remdesivir in hospitalized adult COVID-19 patients with moderate-to-critical disease in Indonesia. Methods: A multicenter, retrospective cohort study was conducted at four COVID-19 referral hospitals in Jakarta. A total of 587 patients were included, of whom 243 received remdesivir within 72 h of admission. The safety endpoints were the proportions of patients with any adverse event (AE), any grade 3 AE, and AE of each system organ class. The effectiveness endpoints were ICU admission >24 h from baseline, live discharge and mortality at day 14, live discharge and mortality at day 28, and virologic conversion. Patients who received remdesivir within 72 h of admission were considered the treatment group, and those who did not were the control group. Multivariate adjustments were performed using a modified Poisson regression. Results: The study found no significant differences in safety endpoints between the two groups. However, the effectiveness endpoints showed that remdesivir was associated with a decreased risk of ICU admission >24 h from baseline (RR 0.71, 95% CI 0.52-0.96), an increased probability of live discharge at day 14 (RR 1.37, 95% CI 1.08-1.74), and an increased probability of live discharge at day 28 (RR 1.28, 95% CI 1.05-1.57). The rate of virologic conversion was not significantly different between the two groups. Conclusion: The study concludes that remdesivir is safe and effective in the treatment of moderate-to-critical COVID-19 in a real-world setting in Indonesia. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Burhan, Syahruddin, Isbaniah, Desianti, Fachrucha, Sari, Ismail, Astuti, Maruli, Mubarak, Rengganis, Bilqis, Taslim, Sastria and Wiyarta.)
Databáze:	MEDLINE
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