Remdesivir (Veklury) was tied to faster clinical improvement in a predominantly non-white group of patients hospitalized with COVID-19, researchers found, though a mortality benefit couldn’t be demonstrated.
In a retrospective analysis of about 2,300 hospitalized COVID-19 patients in Baltimore and Washington, D.C., those receiving remdesivir had a shorter median time to clinical improvement versus those who did not receive the drug (5 vs 7 days, adjusted HR 1.47, 95% CI 1.22-1.79), reported Brian Garibaldi, MD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues.
However, 28-day mortality did not differ significantly, although there was a trend favoring remdesivir (7.7% vs 14.0% for controls. A time-to-death analysis showed even less difference, with medians of 8.6 days for remdesivir versus 8.2 days among controls (adjusted HR 0.70, 95% CI 0.38-1.28), the authors wrote in JAMA Network Open.
Just over 80% of patients receiving remdesivir in the current study identified as non-white, whereas the drug’s clinical trials included only 30% to 47% non-white patients, Garibaldi and colleagues noted.
“Because underrepresented minority groups have shouldered a disproportionate burden during the COVID-19 pandemic but have not been widely represented in clinical trials, our results provide important evidence that receipt of remdesivir is associated with decreased time to clinical improvement in these populations,” the authors wrote.
The FDA approved remdesivir in October 2020, but conflicting data emerged about the drug, including its lack of mortality benefit. NIH COVID-19 guidelines shrank the scope of the drug’s use to hospitalized patients who require “minimal supplemental oxygen.” The agency also lowered the quality of evidence from A (strong) to B (moderate).
Garibaldi and colleagues examined data from patients hospitalized with COVID-19 at five hospitals from March 4 to Aug 29, 2020. Primary outcome was similar to other remdesivir trials: rate of clinical improvement as defined by hospital discharge or a drop of two points on the World Health Organization severity score.
Of the 2,299 patients, 342 received remdesivir, with 184 of those also receiving corticosteroids. Those 342 patients were a median age of 60; 55% were men and 81% self-identified as non-white. Most patients completed a 5-day course of treatment, with a median 1.1 days from admission to treatment.
Garibaldi’s group propensity score-matched 285 patients in the remdesivir group, including 21% self-identifying as non-Latinx white, 33% as non-Latinx Black, and 34% as Latinx. Of these 570 matched patients, 83% of those in the remdesivir group and 75% of controls achieved clinical improvement prior to 28 days.
Patients treated with remdesivir who were breathing ambient air or nasal cannula oxygen had a shorter time to clinical improvement than controls, and even those with more severe disease treated with remdesivir benefited from a shorter improvement time versus controls.
Moreover, patients receiving remdesivir and corticosteroids did not show reduced mortality risk (adjusted HR 1.94, 95% CI 0.67-5.57).
Limitations to the data included potential for unmeasured confounders, such as variables that could bias treatment effect estimates, the authors said. Also, with fewer than 350 patients receiving remdesivir and only 62 deaths overall, the study was likely underpowered for some outcomes and subgroup analyses.
This study was supported by John Hopkins inHealth, the Johns Hopkins Precision Medicine initiative through JH-CROWN, and the COVID-19 Administrative Supplement for the U.S. Department of Health and Human Services Region 3 Treatment Center from the Office of the Assistant Secretary for Preparedness and Response.
Garibaldi disclosed support from Janssen Research and Development LLC and from the FDA Pulmonary-Asthma Drug Advisory Committee.
Other co-authors disclosed support from the NIH, IQVIA, and OptumRx.
One co-author disclosed being a past chair of the FDA Peripheral and Central Nervous System Advisory Committee and being a co-founding principal and equity holder in Monument Analytics.