Curr Drug Saf. 2021 Jul 27. doi: 10.2174/1574886316666210728110330. Online ahead of print.
ABSTRACT
Remdesivir is an adenosine analogue drug that targets RNA dependent RNA polymerase enzyme and inhibits the viral replication. As on 22nd of October 2020, US FDA fully approved drug Remdesivir for the treatment of COVID-19 patients who requires hospitalisation. Many clinical studies reported the derangement in hepatic and renal function tests which is alarming considering the health conditions of the COVID-19 patients. In view of these results, the present study was envisaged to review the safety of Remdesivir in COVID-19 patients. The PubMed, Embase and Cochrane databases was searched using 'Remdesivir', 'veklury', 'SARS' and 'COVID' till 1st of December 2020. The studies included in this meta-analysis were either randomised or non-randomised studies that evaluated Remdesivir for the treatment of COVID-19 against Placebo [standard of care]. The Adverse events [AEs], Serious adverse events [SAEs] and Treatment Discontinuation due to Adverse Events (TDAE) was used as primary outcome measures. The quality of studies was evaluated by using the Cochrane Collaboration's tool for assessment of RoB. Data analysis was performed by two authors (MK & DB) using statistical software Review manager [Revman] version 5.3. The pooled Risk Ratios (RR) and 95% Confidence Intervals (CI) were calculated by using a random-effects model for both primary and secondary outcomes. A total of four RCTs were included for the meta-analysis. Out of the four included clinical trials accepted for its methodological quality, three were of excellent quality and one study was of moderate quality. The pooled estimates of the three studies showed that Remdesivir had 24% lower risk of SAEs compared to placebo arm. However, the pooled estimates of two studies showed that 10 days of Remdesivir had 56% higher risk of SAEs compared to 5 days of Remdesivir regimen. Similarly, the 10 days of Remdesivir had two times higher risk of TDAEs compared to 5 days Remdesivir regimen. In conclusion, our meta-analysis demonstrated that Remdesivir is a safe therapeutic option. Our metanalysis revealed 5 days' regimen have better safety profile than 10 days' regimen of drug Remdesivir with respect to SAEs and TDAEs. For hospitalized patients, a 5-day course could be preferable with fewer safety concerns and lower drug costs.
PMID:34323191 | DOI:10.2174/1574886316666210728110330