A Meta-Analysis of Safety of Different Regimens of Remdesivir in COVID-19 Patients

Title:A Meta-Analysis of Safety of Different Regimens of Remdesivir in COVID-19 Patients

Volume: 17 Issue: 2

Author(s): Mahanjit Konwar, Miteshkumar Maurya and Debdipta Bose*

Affiliation:

• Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel-400 012, Mumbai, Maharashtra, India

Keywords: Adverse events, serious adverse events, randomized controlled trial, 10 days Remdesivir, TDAEs, SAEs.

Abstract: Remdesivir is an adenosine analogue drug that targets RNA-dependent RNA polymerase enzyme and inhibits viral replication. As of 22nd October, 2020, US FDA fully approved the 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 were searched using the terms ‘Remdesivir,’ ‘veklury,’ ‘SARS’ and ‘COVID’ till 1st December, 2020. The studies included in this meta-analysis were either randomised or nonrandomised 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) were used as primary outcome measures. The quality of studies was evaluated by using the Cochrane Collaboration’s tool for the 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 a 24% lower risk of SAEs compared to the 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.

PROSPERO Registration ID: CRD 42020224272.

Cite this article as:

Konwar Mahanjit, Maurya Miteshkumar and Bose Debdipta*, A Meta-Analysis of Safety of Different Regimens of Remdesivir in COVID-19 Patients, Current Drug Safety 2022; 17 (2) . https://dx.doi.org/10.2174/1574886316666210728110330