
As of this morning – Monday June 8 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 286,194 with 40,542 deaths.
The first ever systematic benefit-risk analysis of the antiviral remdesivir for COVID-19 has found a ‘favourable’ profile overall, though safety data remains limited, researchers said.
The study, conducted by the Drug Safety Research Unit (DSRU) in Southampton, UK, and published in the journal Drug Safety, and recorded all possible benefits and risks for COVID-19 patients receiving remdesivir obtained by evaluating public data from peer reviewed journals and some pre-publication clinical trial data.
It found benefits of the antiviral including quicker recovery time, with one study showing median recovery time for remdesivir patients of 11 days compared with 15 days for those on a placebo, as well as slight reductions in mortality: 8% of remdesivir patients compared with 11.6% in patients given a placebo. Further benefits included reductions in the need for invasive and non-invasive ventilation and the need for supportive oxygen.
Due to the limited amount of clinical trial safety data, the researchers said it remains undetermined whether reports of serious adverse events – which include cardiovascular issues, organ dysfunction, acute kidney injury, respiratory failure and septic shock – were caused by remdesivir or COVID-19.
However, the researchers concluded that currently the benefit-risk profile of remdesivir for COVID-19 patients was ‘favourable’ but that the study will need to be updated as more safety data become available.
“Overall our study shows a favourable benefit-risk profile with the clinically significant benefit in reducing recovery time. But the paucity of safety data means we will need to keep reviewing and updating our benefit-risk analysis,” said Professor Saad Shakir, director of the DSRU.
“To that end, we have designed a framework for our study that means we’ll be able to update it quickly as new data becomes available. Understanding the benefit-risk balance is key to understanding the benefits of drugs in general and drugs against COVID-19 in particular.”