Latest COVID-19 guidelines come out against bamlanivimab, remdesivir

The NIH and the Infectious Diseases Society of America found insufficient data to support bamlanivimab, while the World Health Organization said the same about remdesivir. The FDA issued more emergency use authorizations, and research looked at racial and other disparities in COVID-19 outcomes.

Recent guidelines were not supportive of some authorized drug treatments for COVID-19. On Nov. 18, the NIH's COVID-19 guidelines panel issued a statement on the recent emergency use authorization (EUA) for bamlanivimab. The statement, which includes an analysis of the evidence on which the EUA was based, said that there are insufficient data to recommend either for or against the use of bamlanivimab for the treatment of outpatients with mild to moderate COVID-19. The drug should not be considered the standard of care, and hospitalized patients should not receive bamlanivimab outside of a clinical trial, according to the treatment panel. It recommended that clinicians discuss trial participation with patients and prioritize use of the drug in patients with the highest risk of COVID-19 disease progression.

Similarly, the Infectious Diseases Society of America updated its COVID-19 treatment guidelines on Nov. 18 to suggest against routine use of bamlanivimab in ambulatory patients. It is a conditional recommendation, based on very low certainty of evidence, and the guidelines note that in patients at increased risk of progression, bamlanivimab is a reasonable treatment option if, after informed decision making, a patient puts a high value on the uncertain benefits and a low value on uncertain adverse events.

On Nov. 19, the World Health Organization updated its living guideline on COVID-19 treatment to suggest against administering remdesivir in addition to usual care for hospitalized patients, regardless of disease severity. The guideline panel noted that this conditional recommendation was based on the evidence that the drug may have no effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes. The panel clarified that the evidence does not prove that remdesivir doesn't affect these outcomes but also doesn't show that it does. “Especially given the costs and resource implications associated with remdesivir, but consistent with the approach that should be taken with any new drug, the panel felt the responsibility should be on demonstrating evidence of efficacy, which is not established by the currently available data,” said the guideline, published by The BMJ.

The FDA recently issued two additional EUAs for COVID-19 treatments. On Nov. 21, the combination of casirivimab and imdevimab, an IV monoclonal antibody manufactured by Regeneron, was authorized for mild to moderate COVID-19 in adults and some pediatric patients who are at high risk for progressing to severe COVID-19. The treatment is not authorized for patients who are hospitalized or require oxygen therapy. On Nov. 19, an EUA was issued for baricitinib, a janus kinase inhibitor, to be used in combination with remdesivir, for the treatment of COVID-19 in hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Baricitinib is already FDA approved for the treatment of moderately to severely active rheumatoid arthritis.

Evidence on disparities in COVID-19 outcomes was provided by a study published by Circulation on Nov. 17. It included the first 7,868 patients hospitalized with COVID-19 at 88 hospitals participating in the American Heart Association COVID-19 Cardiovascular Disease Registry and found that 35.2% were non-Hispanic White, 33.0% were Hispanic, 25.5% were non-Hispanic Black, and 6.3% were Asian. Black patients had the highest rates of mechanical ventilation (23.2%) and renal replacement therapy (6.6%) but the lowest rates of remdesivir use (6.1%), possibly due to differences in kidney function and trial participation, the authors noted. Overall mortality was 18.4%, and contrary to the study's hypothesis, no differences were found in mortality by race/ethnicity after adjustment. The authors noted that the proportion of Black and Hispanic patients was higher than would be expected based on population data from the U.S. and even hospital ZIP codes. “Our study also provided evidence that the hospital at which the patient was treated contributed significantly to the variation in the odds of poor outcomes,” they said.

Another study, published by Clinical Infectious Diseases on Nov. 19, looked at county-level predictors of COVID-19 infections and deaths. It found that both were higher in U.S. counties that were more urban or densely populated or that had more crowded housing, air pollution, women, 20- to 49-year-olds, racial/ethnic minorities, residential segregation, income inequality, uninsured or diabetic patients, or mobility outside the home during the pandemic. The findings are novel in that they show disparities in infections and deaths by race and socioeconomic status even when there is adjustment for potentially confounding factors, the authors said. The study was funded by Pfizer, and all of the authors were Pfizer employees.

Finally, the November issue of ACP Hospitalist focuses on readers' experiences during the pandemic, including a cover story on the initial responses to the pandemic in New York City, New Orleans, and Phoenix and hospitalists' poems and essays about patient encounters, collaboration with colleagues, stories about families, and more. These writings, which range from humorous to heartbreaking, are divided into parts 1, 2, and 3 on ACP Hospitalist's website.