Early in the coronavirus pandemic, remdesivir, an infusion therapy developed by Gilead Sciences, was the first coronavirus treatment authorized by federal regulators for use in hospitals. Wednesday's study, published in the New England Journal of Medicine, is the first to show that remdesivir can be useful when given on an outpatient basis in the community.
The findings are based on research that predates the delta variant that proliferated during the summer and omicron, the variant spreading with great speed globally. But the study's main author and other researchers said remdesivir is likely to remain effective even as omicron proves resistant to most medicines in a group known as monoclonal antibodies that have helped prevent people from needing to be hospitalized. Many hospitals are bulging with patients and short on staff.
The study focused on unvaccinated patients, the group most likely to become seriously ill or die if infected.
"If you are going to be a skydiver and jump out of your own plane, it's best to pack a primary chute as well as a secondary chute," said the study's principal investigator, Robert L. Gottlieb, the therapeutic lead for covid-19 research at Baylor Scott & White Health, a medical system in Dallas.
"Vaccines are a primary chute," Gottlieb said, while therapies such as remdesivir "are the secondary chute."
Shyam Kottilil, director of the division of clinical care and research at the University of Maryland School of Medicine's Institute of Human Virology, said, "Infectious-disease doctors would really like to treat people for covid-19 outside the hospital. Any measure that would accomplish that is really beneficial."
Kottilil, co-author of an editorial in the New England Journal of Medicine accompanying the study, cautioned that the findings do not establish how well remdesivir would work early on with coronavirus patients who are vaccinated and boosted but experience breakthrough infections.
Another limitation of the findings, he said, is that remdesivir is administered by infusion, and it could be cumbersome for sick patients to go to a location to get such treatment three days in a row. The three-day regimen is shorter than the treatment period in earlier research into the drug. Still, Kottilil said, "We would rather have something by mouth, that would be an easier medication to take."
The Food and Drug Administration on Wednesday authorized the first antiviral pill to treat covid-19, a drug known as Paxlovid developed by Pfizer that must be taken shortly after symptoms develop.
And Tuesday, scientists from the Johns Hopkins Bloomberg School of Public Health and Johns Hopkins University School of Medicine published data from a clinical trial suggesting that convalescent plasma, taken from blood donated by people who have recovered from the virus, could be effective against omicron when given to outpatients soon after becoming infected.
The remdesivir findings were based on a study, sponsored by Gilead, involving 562 unvaccinated covid-19 patients from September 2020, to April, who were randomly selected to receive the three-day infusion therapy or a placebo. The trial initially was designed to include more than twice as many patients but was halted early once monoclonal treatments were available and vaccines had become more widely accessible. With those options available, giving half the study participants a placebo seemed unwise.
All the participants were at high risk for developing a severe case because they were 60 or older or had at least one other condition that makes covid-19 more dangerous, such as high blood pressure, cardiovascular disease, diabetes or obesity.
Nearly a month after joining the study, two of 279 people treated with remdesivir were hospitalized for reasons related to covid-19, compared with 15 of 283 who received the placebo. No one in either group died within that time frame.
Overall, the risk of hospitalization or death - the main outcomes the study set out to measure - was 87% lower in the group that got the treatment.
Symptoms also eased more quickly with the treatment, with 36% of those getting remdesivir reporting improved symptoms by the end of the study's second week, compared with 20% among those who did not.
On the other hand, the amount of virus in patients' bodies - known as the viral load - did not differ depending on whether people were treated.
Gottlieb, the principal investigator, said the FDA has the study's data. Because the drug has full FDA approval, doctors already may prescribe it for other uses. This week, the European Commission widened its "conditional marketing approval" of remdesivir, marketed as Veklury, to include high-risk patients beyond those who need extra oxygen while in the hospital, Gilead announced.
Gottlieb said that, early in the pandemic, people who had the virus but were not sick enough to be in a hospital were advised to quarantine at home.
"The message for going into 2022," Gottlieb said, is that people with covid-19 and any risk factors for a serious case should "perform a more active quarantine" by contacting their doctor quickly to find out whether treatment is available that could prevent them from becoming seriously ill or dying.
Published : December 23, 2021
By : The Washington Post