Q&A: Remdesivir a ‘go-to’ COVID-19 treatment, but questions remain
Last month, Anthony S. Fauci, MD, announced unpublished data from a phase 3 trial that showed remdesivir shortened the time to recovery for patients with COVID-19 from 15 days to 11 days.
Fauci, the director of the National Institute of Allergy and Infectious Diseases, said he believed Gilead Science’s investigational antiviral “will be the standard of care” for the new disease.
Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) were finally published recently in The New England Journal of Medicine, with the same conclusion: Among more than 1,000 patients hospitalized with COVID-19 in 10 countries who had evidence of lower respiratory involvement, IV remdesivir — given as one 200 mg loading dose followed by 100 mg daily for up to 9 days — shortened the time to recovery compared with placebo from 15 days (95% CI, 13-19) to 11 days (95% CI, 9-12).
Estimated mortality was numerically lower in the remdesivir arm, but not significantly different, researchers reported.
In another phase 3 trial published in The New England Journal of Medicine, researchers found no significant difference in outcomes among almost 400 patients with COVID-19 in eight countries who were treated with either 5 or 10 days of IV remdesivir. “With no placebo control, however, the magnitude of benefit cannot be determined,” they wrote.
Healio spoke with C. Buddy Creech, MD, MPH, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program at Vanderbilt University School of Medicine, to discuss remdesivir’s place in treating patients with COVID-19. Creech was a co-author of the article on the ACTT-1 findings. – by Caitlyn Stulpin
Q: Does what Fauci said hold true: Is this the standard of care?
A: Defining the standard of care early in a pandemic is remarkably challenging, and we are learning as quickly as possible where we can intervene in the safest and most effective ways. The preliminary data from the remdesivir trial suggest that remdesivir is fairly well tolerated and results in shortened hospital stays and decreased mortality. It will be very exciting to evaluate the entire dataset once those data are available. Given that this is the first COVID-specific therapy proven to have benefit, it makes sense for it to become a go-to drug where available.
Q: What are the remaining questions regarding remdesivir and treating patients with COVID-19?
A: As you can imagine, there are a number of remaining questions. One of the biggest relates to when we give the drug. We assume that giving remdesivir earlier in the disease will have even greater impact. This assumption is based on in vitro data, as well as small animal data and data from China. In [ACTT-1], patients often received the drug fairly late into symptoms, and we were still able to show benefit. This is important because we think about tailoring antivirals and anti-inflammatory drugs in different types of patients.
Q: How are hospitals using it? Should the drug be administered for 10 days, as in the study? Or are shorter courses just as effective?
A: Again, this is an unanswered question, although the preliminary reports from short course use suggest that it may be effective when given as a 5-day course (rather than 10-day course as in our study). Every patient, at this point, must be individualized, but there are many who will benefit from shorter courses. In many hospitals, this is the default approach in order to make the drug available for more people.
Q: Who should and should not receive it?
A: In general, we would like to be able to give COVID-specific antiviral medication to anyone diagnosed with COVID-19. Remdesivir is a bit limited because it is only given as an IV formulation. More than this, it is in fairly limited supply at this point. At many hospitals, physicians are earmarking the drug for critically ill patients or those who have underlying immunocompromising conditions (eg, patients who have undergone organ transplantation). Patients with very mild disease, or those who are being managed as outpatients, are likely not the best candidates for remdesivir at this point.
Disclosures: Creech reports no relevant financial disclosures. Please see the studies for all other authors’ relevant financial disclosures.