Updated National Institutes of Health guidelines narrowed the scope of recommended use for remdesivir (Veklury) in hospitalized COVID-19 patients, and the quality of evidence backing the drug’s use also took a hit.
In a revision to its therapeutic management guidelines released on Thursday, the NIH no longer recommends remdesivir with dexamethasone as an option for hospitalized COVID-19 patients who require mechanical ventilation or ECMO, recommending only dexamethasone instead.
For patients who are hospitalized and require supplemental oxygen, remdesivir is recommended for patients who require “minimal supplemental oxygen,” with dexamethasone and remdesivir recommended for patients who require “increasing amounts” of supplemental oxygen. The rating of recommendations for remdesivir also dropped from A (strong) to B (moderate).
Previously, remdesivir was recommended for hospitalized patients requiring supplemental oxygen, with dexamethasone only recommended in this population if remdesivir could not be used. The agency didn’t specify what prompted the new skepticism about the drug.
For hospitalized patients who do not require supplemental oxygen, NIH still says there is “insufficient data” to recommend for or against the use of remdesivir.
Updates to NIH guidelines come on the heels of interim results for the World Health Organization’s Solidarity trial being published Wednesday in the New England Journal of Medicine. WHO researchers found no mortality benefit for remdesivir overall or in any subgroup of hospitalized patients.
A NEJM editorial by David Harrington, PhD, of Harvard T.H. Chan School of Public Health in Boston, and colleagues characterized the case for continued use of remdesivir as “nuanced.” The editorialists pointed out that Solidarity results were inconsistent with the Adaptive Covid-19 Treatment Trial conducted by the National Institute of Allergy and Infectious Diseases, which found remdesivir led to significant reductions in median time to recovery, but no mortality benefit versus placebo.
“Even without a reduction in in-hospital mortality, reducing the time to recovery and hospital discharge among patients who survive is important, both for patients and for stressed health care systems,” Harrington’s group wrote, citing the NIAID study as the basis for FDA approving the drug.
Harrington and colleagues encouraged more research about exact timing of remdesivir use, whether it should be used in combination with other agents or reserved for treating patients with selected risk factors, but warned, “it will not be simple to achieve clarity on when and how — or even whether — to use remdesivir.”
In addition to changes in remdesivir recommendations, NIH guidelines now include references to recently authorized monoclonal antibody treatments, bamlanivimab or casirivimab plus imdevimab. While the guidelines state there is still “insufficient data” to recommend for or against their use, they also state they are available through FDA emergency use authorization for patients at high risk of disease progression.
Last Updated December 04, 2020
Source: MedicalNewsToday.com
