The Drug Safety Research Unit (DSRU), based in Southampton, UK, has found a ‘favourable’ profile for Gilead’s antiviral drug remdesivir in COVID-19 after conducting a systematic benefit-risk analysis.
The study, published in the journal Drug Safety, 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 the benefits of remdesivir included quicker recovery time, with one study showing median recovery time for remdesivir patients of 11 days compared with 15 days for those on placebo.
The analysis also found slight reductions in mortality, although this was not statistically significant, with 8% of remdesivir patients dying compared to 11.6% in patients given a placebo.
The researchers said it was unclear if reports of serious adverse events were caused by COVID-19 or remdesivir treatment, due to the limited clinical trial safety data.
The DSRU researchers concluded that overall the benefit-risk profile of remdesivir for COVID-19 patients was ‘favourable’, although they added that the study would need to be updated as more safety data becomes 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,” he added.