COVID-19 Update - Remdesivir receives FDA Authorization
by Mackenzie Gignac
Remdesivir Receives United States Food and Drug Administration (FDA) Authorization to Treat COVID-19
We wrote about Remdesivir three weeks ago. This is an experimental anti-viral drug developed by Gilead Sciences, that was previously tried against Ebola and hepatitis without success. This drug works by blocking a class of enzymes (called RNA polymerases) across a broad range of viruses including COVID-19. At that time, the drug was only reported in a small number of patients who received the drug on compassionate access. Among these patients, the rate of death was at the lower end of what would be expected for patients with severe COVID-19 disease treated in a conventional manner (ie without antiviral drugs). So, there was a subtle signal that the drug may be useful, but it was not a game-changer.
The FDA has now given emergency use authorization for Remdesivir in the United States. Note that this is NOT the same as full approval of the drug. Full approval means the drug has been fully evaluated and shown to be safe and effective.
The current decision to allow emergency use is driven by the early results of a new study, where patients are randomly assigned to treatment with Remdesivir, or placebo. This kind of experiment is the only objective way to tell if the drug truly works or not.
So, what do we know about the results of this study?
- Firstly, very little details are available about this study, as the study is not published in any medical journal as of today. This means that independent experts are currently reading the study report and making sure that the conclusions are correct.
- We do know the study was coordinated by the National Institute of Health in the US, and that it started on February 21st, enrolling 1063 patients.
- Patients who received Remdesivir recovered faster than those who received placebo – 11 days for Remdesivir, compared with 15 days for placebo. This difference is statistically proven to be real and not due to chance.
- The rates of death appear to be lower in patients receiving Remdesivir (8.0% died) when compared with placebo (11.6% died). However, this difference is not statistically proven to be real, and could have happened by chance.
Under the current FDA authorisation, this drug cannot be taken to prevent COVID-19, but rather, can be only use din patients who are hospitalized with severe COVID-19 requiring oxygen or ventilation support, in the hope of a faster recovery.
The take home message is that the drug has some activity against COVID-19 but is not the same as antibiotics for normal infections, where if one receives antibiotics on time, we can normally expect a full recovery. The drug is a useful addition to normal care but is not a “magic bullet” against COVID-19. Even if we accept the death rates at face value, the most Remdesivir did was in reducing the chance of dying from COVID-19 from 1-in-9, to 1-in-12. It is not another penicillin.
The best thing to do is not to catch COVID-19 in the first place, so keep up the precautions as we relax social isolation across Australia.
Stay safe everybody
Professor Con Tam, Associate Professor Ali Bazargan, Associate Professor Hang Quach, Dr ShuhYing Tan, Dr Matthew Ku and all the staff from Melbourne Blood Specialists.