Despite FDA Approval of Remdesivir, Experts Say Public Health Strategies Are Still Essential

Following the recent FDA approval of remdesivir for the treatment of patients hospitalized with coronavirus disease 2019 (COVID-19), global interest in the drug has skyrocketed. Despite this, investigators say the treatment still has lingering questions and that public health strategies, such as mask-wearing and social distancing, are just as important as ever.

Studies of remdesivir have presented conflicting evidence, with the largest trial from the World Health Organization (WHO) showing no benefit in reducing hospital stays or mortality. Still, the antiviral was approved October 22 and is currently the only approved COVID-19 treatment in the United States.

In a commentary published in Contemporary Clinical Trials Communications, investigators reviewed all available evidence for remdesivir, especially the most reliable data from randomized trials. Based on their research, the commentary authors concluded that the current totality of evidence prior to the WHO trial justifies compassionate use of remdesivir for severely ill patients.

“Remdesivir significantly decreased mean recovery time with no suggestion of a mortality benefit in a small trial in China,” said first author Richard D. Shih, MD, in a press release. “Subsequently, the larger Adaptive COVID-19 Treatment Trial, of ACTT-1, found the same improvement in mean recovery time and a suggestion of a mortality benefit, which did not achieve statistical significance.”

The authors said dexamethasone is the only other drug with an FDA approval based on a large randomized trial showing a mortality benefit among patients receiving either invasive mechanical ventilation or oxygen alone at randomization, but not among patients receiving no respiratory support.

According to the press release, the authors believe that cases and deaths in the United States throughout the fall and winter will far exceed those of spring 2020 unless there is effective implementation of nationally coordinated efforts and preventive strategies. These efforts could include stay-at-home orders, mask mandates, and social distancing measures.

“The US accounts for less than 5% of the world’s population but more than 20% of the global cases and deaths,” said senior author Charles H. Hennekens, MD, DrPH, in the press release. “We need far wider utilization of the preventive strategies of proven benefit of social distancing, crowd avoidance, masking, and frequent hand washing. While vaccine development and further research on other drug therapies to treat and prevent COVID-19 are a necessity, don’t let the ‘perfect be the enemy of the possible.’”

REFERENCE

Remdesivir for COVID-19: FDA Approves But Still Unproven [news release]. Florida Atlantic University; October 29, 2020. http://www.fau.edu/newsdesk/articles/remdesivir-coronavirus.php. Accessed October 30, 2020.