An editorial in the influential New England Journal of Medicine cites problems with a World Health Organization (WHO) study that found Gilead Sciences Inc's antiviral remdesivir failed to improve COVID-19 survival, and said it does not refute trials that demonstrated benefits of the drug in treating the illness.
The editorial, by David Harrington at the Harvard T.H. Chan School of Public Health, infectious disease specialist Dr. Lindsey Baden and Brown University biostatistician Joseph Hogan, was published on Wednesday along with the WHO study.
They noted that the trial called Solidarity, which looked at four drugs, was conducted in 30 countries ranging from Switzerland and Germany to Iran and Kenya, leading to inconsistencies in the data collected.
The findings are complicated by the fact that there is "variation within and between countries in the standard of care and in the burden of disease in patients who arrive at hospitals," they write.
Solidarity also found no COVID-19 survival benefit from treatment with the HIV drug lopinavir, the immune booster interferon or hydroxychloroquine, a malaria drug championed by U.S. President Donald Trump despite a lack of evidence of benefit in COVID-19.
The release in October of the trial's summary findings sparked a reevaluation by some of the utility of remdesivir, which was shown to shorten COVID-19 hospitals stays by five days compared with a placebo in an earlier U.S. government-run trial.
Solidarity "did not collect or report the standard of care or the healthcare system capacity in any of the 400 hospitals from 30 countries," said Dr. Andre Kalil, infectious disease specialist at the University of Nebraska Medical Center and lead investigator of the U.S. trial.
"If the basic supportive care is scarce or inadequate, no treatment drug will show much benefit even if known to be effective, because the adequate supportive care is essential for the survival of patients hospitalized with COVID-19," he said.
The WHO last month declared that remdesivir, which is given as an intravenous infusion, should not be used for patients hospitalized with COVID-19, regardless of how ill they are, since there is no evidence that it can improve survival or reduce the need for mechanical ventilation.
The U.S. Food and Drug Administration in October approved remdesivir, which is sold under the brand name Veklury, for COVID-19 patients over the age of 12 who require hospitalization. The drug is authorized or approved for use as a COVID-19 treatment in more than 50 countries.
Both the U.S. Infectious Diseases Society of America and the National Institutes of Health, which conducted the U.S. study, in recent weeks reaffirmed their guidelines for use of remdesivir following the FDA's full approval of the drug.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.