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HHS Reveals Plan for Shipping Remdesivir to Hospitals for COVID-19
An HHS agency has started to ship donated remdesivir, a potential COVID-19 treatment, to a handful of states where state health departments will distribute to hospitals.
Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS recently announced the allocation plan for remdesivir, a COVID-19 treatment for hospitalized patients.
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HHS noted the candidates for remdesivir are patients on ventilators or those who need supplemental oxygen due to room-air blood oxygen levels at or below 94 percent. The maker of the drug, Gilead Sciences, donated the cases of remdesivir earlier this month. The drug has also received Emergency Use Authorization from the FDA.
Last week, the process was initiated to deliver cases of 40 vials of remdesivir to certain states, including, Connecticut (30 cases), Illinois (140 cases), Iowa (10 cases), Maryland (30 cases), Michigan (40 cases), and New Jersey (110 cases).
State health departments will grant certain dosages to hospitals in their states because state and local health departments have insight into community-level needs in the COVID-19 response, HHS explained. This includes necessary distribution of the treatment in limited supply.
An initial allocation was sent to seven states, including Indiana (38 cases), Massachusetts (117 cases), New Jersey (94 cases), New York (565 cases), Rhode Island (30 cases), Tennessee (7 cases), and Virginia (33 cases).
ASPR expects cases to be delivered to all 50 states as well as various territories.
The National Institutes of Health (NIH) and Gilead conducted a randomized controlled clinical trial of the investigational drug in hospitalized patients. HHS stated that the preliminary results suggested that remdesivir was associated with faster recovery, but the data was not sufficient to determine if the drug was associated with lower mortality.
At the time of the trial, there were 77,262 coronavirus cases in the US. Today, there are over one million cases countrywide. Remdesivir showed in vitro and in vivo activity in animal models against previous diseases including MERS and SARS.
But Anthony S. Fauci, MD, NIAID director and US Coronavirus Task Force member stated that the trial did not show solid data to indicate that remdesivir could improve clinical outcomes. He said a randomized, placebo-controlled trial is the “gold standard” for determining if an experimental treatment can benefit patients.
Gilead said that it will supply nearly 607,000 vials of the experimental drug over the next six weeks to treat an estimated 78,000 hospitalized COVID-19 patients under the EUA.
The donation to the United States is part of 1.5 million vials of remdesivir the company is donating worldwide.
At the end of April, Gilead uncovered that using remdesivir as a COVID-19 treatment for severe coronavirus patients produced positive results in a Phase 3 clinical trial. Severe coronavirus patients receiving a ten-day treatment of remdesivir achieved similar clinical improvement compared with those taking a five-day treatment course, the company announced earlier today.
The randomized trial consisted of 397 patients who received remdesivir 200 mg on the first day, followed by remdesivir 100 mg each day until day 5 or 10. These patients also received standard COVID-19 care.
The Phase 3 clinical trial found that the time to clinical improvement for 50 percent of patients was ten days in the five-day treatment group and 11 days in the ten-day treatment group.
Over half of patients in both treatment groups were discharged from the hospital by day 14. At day 14, 64.5 percent of patients in the five-day treatment group and 53.8 percent of patients in the 10-day treatment group achieved clinical recovery.
Researchers defined patient improvement as improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support, to death.
“The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” Gilead stated in the announcement. “This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
