Remdesivir was originally developed to treat hepatitis C, and was subsequently investigated as a post-infection treatment for COVID-19. During the COVID-19 pandemic, remdesivir was approved or authorized for emergency use to treat COVID-19 in around 50 countries. It was the first antiviral to be FDA approved for the treatment of COVID-19 in October 2020.

Several large, randomized trials have been published on the use of remdesivir in hospitalized patients with COVID-19. Some treatment trials of remdesivir showed a reduction in time to clinical improvement and, in subgroup analysis, a mortality benefit in patients requiring supplemental oxygen but not ventilation. Conversely, some trials showed no mortality benefit with the use of remdesivir. Notably, the trials had different primary endpoints, and there was no similar data available in this treatment trials. In patients with severe Covid-19 not requiring mechanical ventilation, trials did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no therapeutic effect, however, the magnitude of benefit cannot be determined. On the other hand, the pregnant patients with severe COVID-19 who received compassionate use remdesivir, the therapy was well tolerated, with a low rate of serious adverse effects.

During the second wave of covid, the health department had no system in place to check whether every patient really needs this injection. The treating doctor was the only authority to decide. There was shortage of remdesivir in hospitals and black marketing of remdesivir was in high demand during the second wave of Covid. Also, remdesivir can cause cardiac arrest during the treatment. Multiple organ dysfunction, septic shock, acute kidney injury and hypotension have also been reported as adverse events amongst patients provided with remdesivir either on a compassionate-use basis, or in a clinical trial. Respiratory failure or acute respiratory distress syndrome has been cited as an adverse event in patients taking remdesivir, and as such has been included here, although it is acknowledged that this may be related to underlying disease (COVID-19), rather than to remdesivir. Elevations in liver transaminases and gastrointestinal events, including diarrhoea, have also been reported with the use of remdesivir.

Overall, there is conflicting data, but it appears based on randomized trials that remdesivir does not provide an overall mortality benefit to the aggregated group of patients hospitalized with COVID-19, but it does reduces time of clinical improvement when given early in the course of illness and/or in patients with mild hypoxia but less severe disease. While observational trials are more difficult to judge, large-scale comparative efficacy studies suggest that remdesivir may have a modest mortality benefit.

Sakshi Gholap

S. Y. B. Pharm

Tags: MET Institute of Pharmacy