Fauci calls it 'highly significant'
A top U.S. health official said Gilead Sciences Inc’s experimental antiviral drug remdesivir is likely to become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped certain patients recover more quickly from the illness caused by the coronavirus.
Preliminary results from a U.S. government trial show that patients given remdesivir had a 31% faster recovery time than those who received a placebo, results hailed by Dr. Anthony Fauci, the nation’s top infectious disease expert, as “highly significant.”
Gilead earlier on Wednesday said remdesivir helped improve outcomes for patients with COVID-19 in the government-run trial, and provided additional data suggesting it worked better when given earlier in the course of illness, sending its shares up more than 7%.
“The data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.” (...)
Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases, until a preventive vaccine emerges.
“There’s now enough data to support consideration of access under an emergency use authorization by FDA,” former U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Twitter.
Gilead provided information on two clinical trials. The study conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, met its main goal of helping patients with a range of severity of COVID-19, the disease caused by the novel coronavirus.
Those results have been highly anticipated because it compares how patients who received remdesivir fared versus those given a placebo, meaning it should definitively demonstrate whether the drug provides benefit. (...)
Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, said more information is needed.
“While a new study offers a glimmer of hope that ... remdesivir has an effect against COVID-19, determination of its benefit for the general population must await release of pertinent details to evaluate the study’s findings and scientific analysis comparing them to other studies of the drug that have shown mixed results,” he said in a statement.
Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centers, which does not have a placebo comparison but tested the drug given by intravenous infusion under five-day and 10-day regimens.
In that 397-patient trial, Gilead said 62% of patients treated early with remdesivir were discharged from the hospital, compared with 49% of patients who were treated later in the course of the infection.
Gilead Chief Medical Officer Merdad Parsey in a statement said a five-day regimen, “could significantly expand the number of patients who could be treated with our current supply of remdesivir.”
by Deena Beasley, Manas Mishra, Reuters | Read more:
Image: via
A top U.S. health official said Gilead Sciences Inc’s experimental antiviral drug remdesivir is likely to become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped certain patients recover more quickly from the illness caused by the coronavirus.
Preliminary results from a U.S. government trial show that patients given remdesivir had a 31% faster recovery time than those who received a placebo, results hailed by Dr. Anthony Fauci, the nation’s top infectious disease expert, as “highly significant.”
Gilead earlier on Wednesday said remdesivir helped improve outcomes for patients with COVID-19 in the government-run trial, and provided additional data suggesting it worked better when given earlier in the course of illness, sending its shares up more than 7%.
“The data shows that remdesivir has a clear cut significant positive effect in diminishing the time to recover. This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.” (...)Interest in Gilead’s drug has been high as there are currently no approved treatments or preventive vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases, until a preventive vaccine emerges.
“There’s now enough data to support consideration of access under an emergency use authorization by FDA,” former U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Twitter.
Gilead provided information on two clinical trials. The study conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, met its main goal of helping patients with a range of severity of COVID-19, the disease caused by the novel coronavirus.
Those results have been highly anticipated because it compares how patients who received remdesivir fared versus those given a placebo, meaning it should definitively demonstrate whether the drug provides benefit. (...)
Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, said more information is needed.
“While a new study offers a glimmer of hope that ... remdesivir has an effect against COVID-19, determination of its benefit for the general population must await release of pertinent details to evaluate the study’s findings and scientific analysis comparing them to other studies of the drug that have shown mixed results,” he said in a statement.
Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centers, which does not have a placebo comparison but tested the drug given by intravenous infusion under five-day and 10-day regimens.
In that 397-patient trial, Gilead said 62% of patients treated early with remdesivir were discharged from the hospital, compared with 49% of patients who were treated later in the course of the infection.
Gilead Chief Medical Officer Merdad Parsey in a statement said a five-day regimen, “could significantly expand the number of patients who could be treated with our current supply of remdesivir.”
by Deena Beasley, Manas Mishra, Reuters | Read more:
Image: via
