COVID-19 Treatments: Remdesivir Antiviral Drug
A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19.
COVID-19 continues to cause damage to both the public health and the economy at large. New infections are accelerating again, and a “third” wave of infections, hospitalizations and more deaths seems imminent.
There is some good news on the horizon. The FDA has just approved a new antiviral drug, Remdesivir from Gilead Sciences, for treating COVID-19 patients needing acute care in a hospital. This treatment was available until now under an Emergency Use Authorization (EUA), but a full FDA approval will facilitate broader use.
EUA for monoclonal antibody treatment is expected soon. Dexamethasone, a steroid treatment to alleviate a severe systemic inflammatory response that can lead to lung injury, is also being used for treating severely ill COVID-19 patients. Vaccine development is also moving along at a fast pace and a viable safe and effective vaccine is imminent by the end of the year.
Understanding the Benefit-Risk of Emerging Treatments
No doubt, there is a lot going on right now. But we also hear many confusing stories about timing, benefits and risks of these rapidly emerging treatment options. It is against this background that we have launched a new video series that will attempt to present available technical information on these emerging treatment options in a fair, balanced way so we can clearly understand the benefit-risk.
In the second video of our series, we are discussing the Remdesivir antiviral treatment from Gilead Sciences. We review the results of a clinical trial of nearly 1100 patients, with about half receiving the 10-day Remdesivir treatment, and the other half receiving a placebo. These results highlight the key benefit of a significantly faster recovery time in the Remdesivir treatment group. Median recovery time was 10 days compared to 15 days for the placebo group. An improvement in the odds ratio for recovery was also seen on the 15th day as a secondary outcome of the study.
Many questions still remain unanswered. FDA is requiring additional post-market studies. We will continue to provide our analysis as new information becomes available in the future.
Check out the video below for details and let us know if you have any questions or comments.
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