New data on the experimental drug remdesivir confirms it can shorten the course of COVID-19 infections and suggests it also can save lives.
Gilead Sciences, Inc. of Foster City, California, which makes the drug, revealed new data Friday about nearly 400 patients in its late-stage clinical trial.
According to the new results, 74% of patients treated with remdesivir had recovered by their 14th day of hospitalization, compared to 59% of those who did not get the drug. Nearly 8% of the patients on remdesivir had died by day 14, versus more than 12% of patients who did not receive it.
The study also found patients who took the drug hydroxychloroquine along with remdesivir fared worse than those on remdesivir alone. The company recommended against using the drugs in combination.
Remdesivir, an antiviral initially developed to treat Ebola, has not yet been approved for widespread use by the US Food and Drug Administration, but it has been given emergency use authorization to treat COVID-19 patients.
The United States has bought up 90% of the world’s stock of remdesivir, one of only two drugs that has been shown effective against COVID-19. Both are recommended for use in certain patients by the National Institutes of Health and the Infectious Disease Society of America.
The other drug, dexamethasone, a steroid, has been shown in early research to be lifesaving for the most seriously ill COVID-19 patients. That study found the steroid was not useful for patients who do not need oxygen, but further research is underway.
For remdesivir, according to a May study in the New England Journal of Medicine, the drug shortened the recovery time of those hospitalized with COVID-19 and lower respiratory tract infections.
Gilead is rushing to ramp up production of remdesivir and also to make an inhaled version of the drug, which now can only be delivered intravenously. Theoretically, an antiviral should work best early in the course of a viral infection, so there is some hope that remdesivir will be useful for people who have been recently exposed to the virus, but that has not been confirmed with research.
According to the newly released results, remdesivir appeared to be safe and effective in high-risk groups.
The improvements varied by race, although patients in all groups showed benefit, according to the company’s data. Of the 229 COVID-19 patients in the United States taking remdesivir and included in the study, 84% of Black patients showed improvement by day 14 after hospitalization, compared to 76% of Hispanic white patients, 67% of Asian American patients and 67% of non-Hispanic white patients.
The drug also is apparently safe for children and pregnant women with COVID-19, with no new safety concerns raised in the new data. Of 77 children treated with remdesivir, 56 were released from the hospital within a month, while three died. Among pregnant and postpartum women, about 90% achieved clinical recovery. The company has launched detailed studies of both groups.
Dr. Thomas Tsai, an assistant professor at Harvard T.H. Chan School of Public Health and a surgeon at Brigham and Women’s Hospital, both in Boston, said he’s happy that drugs are reducing the risks of serious COVID-19 infections.
But, he said in a Friday call with media, “none of this is a silver bullet that’s going to make the coronavirus go away.”