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Updated June 25, 2020 // Editor's note: This article originally stated that remdesivir is approved for the treatment of COVID-19 in the United States. Remdesivir has not been approved by the FDA for the treatment of COVID-19 or for any other disease. Remdesivir's manufacturer was granted emergency use authorization due to the ongoing COVID-19 pandemic on May 1, 2020.
The federal government will distribute nearly all of its remaining supply of remdesivir to states by June 29, while holding back less than 2% of the original donation "in the event 'hotspots' emerge in the coming weeks," according to a spokesperson for the Department of Health and Human Services (HHS).
Shortly after remdesivir received an emergency use authorization (EUA) from the Food and Drug Administration (FDA) in early May, the manufacturer, Gilead, donated its entire existing stock to the US government. A week later, the federal government said it would send the drug stock to states and US territories, which would be responsible for distributing it to individual hospitals.
After initial confusion around how the experimental drug would be allocated, physicians across the country report their hospitals currently have sufficient access to remdesivir. Yet, on-going access remains uncertain.
How much remdesivir Gilead will be able to produce, and how and when that supply will be allocated and distributed, is currently unclear. "We are currently in conversations with Gilead to determine what inventory will be available and when," the HHS spokesperson told Medscape Medical News.
Gilead has said it is rapidly scaling up a complicated supply chain to produce a drug that wasn't being manufactured at all as of January in order to meet demand. The company had said it aimed to produce 140,000 courses of remdesivir by the end of May 2020, 500,000 treatment courses by October, more than 1 million by December, and "several million" in 2021, if necessary. However, Gilead has not released updated information about the current status of its manufacturing or supply, nor did the company respond to a request for comment from Medscape Medical News.
Current Supplies Adequate, Future Uncertain
Hospitals are trying to use the remdesivir supplies they do have as judiciously as possible with incomplete, ever-evolving information. Because the supply is uncertain, administrators and doctors worry that if one patient gets the drug there won't be enough for someone else. Experts interviewed for this story seemed to accept that they may need to adjust their existing protocols if supplies run low to prioritize the patients with the most need.
"That's the problem. That's the most difficult part — how much more you're getting and when you're getting it," says Onisis Stefas, PharmD, MBA, vice president of pharmacy at Northwell Health in New York.
"From the very beginning, we were concerned about inadequate supply based on COVID-19 cases and put together guidelines for those that would receive it across our hospital system. We are continuing to do this today and will monitor the situation of COVID positive patients that need the medication versus the supply. If we get low, we can always change our protocol to make sure the patients who need it the most are able to receive it," Stefas said.
Ochsner Health in New Orleans, Louisiana, has enough supply to continue to treat hospitalized patients with moderate-to-severe disease who meet the treatment criteria, says Sandra Kemmerly, MD, MACP, FIDSA, an infectious disease physician and current System Medical Director of Hospital Quality for the health system. As of June 10, Ochsner physicians have treated 36 patients with remdesivir and have enough stock to treat 200 - 225 patients, depending on whether patients need a 5- or 10-day treatment course, she said. "While I am concerned that the continued distribution of routine supply is unknown, we have not altered our approach for treatment and are not 'rationing' at this time."
"Currently we have an adequate supply for the next few months for our current rate of cases," says Aneesh Mehta, MD, associate professor of infectious diseases at Emory University School of Medicine, Atlanta, Georgia, and lead investigator at Emory University for the National Institute of Allergy and Infectious Diseases (NIAID) remdesivir trial. "However, if there is a significant increase in cases, we would risk depleting our stock from the Emergency Use Authorization (EUA) allotment to our hospital."
Expanding Demand, Unknown Supplies
The FDA has not released any further information on if (and when) remdesivir could receive full approval from the agency. It's also unclear if that approval would prompt the company to start selling, rather than donating, the drug, and how that could reshape access, particularly for vulnerable patient populations that have already been disproportionately affected by the pandemic.
But demand for remdesivir is now global, which could further strain supplies. The drug has been approved for treating COVID-19 patients in Japan and the United Kingdom, and the European Union has said it is evaluating remdesivir for possible "conditional marketing approval." Clinical trials of remdesivir are stalled in Canada, which has not yet approved the drug, because Health Canada does not yet have access to the drug, Nelson Lee, MD, MBBS, professor of infectious diseases at the University of Alberta in Canada, told Medscape Medical News via email.
For its part, Gilead has said it is committed to providing the drug to patients around the world, but has not released details about how it plans to scale up manufacturing to supply enough doses to potentially treat millions of people, including those in emerging hot spots around the world, such as Brazil or Russia.
While physicians in the United States say they have adequate supplies of remdesivir right now, it's unclear how long that will be the case, as many states are seeing case numbers rise. If there's an uptick in cases in coming weeks or months, Gregory Huhn, MD, infectious disease physician at Cook County Health in Chicago, Illinois, and principal site investigator of the remdesivir drug trials, hopes Gilead would be able to increase the amount of drug available to match the increasing demand. "We're fortunate that we're able to actually have this drug available for our patients in urgent need," says Huhn, noting that Cook County Health treats highly impacted patient populations in the Chicago area that traditionally struggle with access to healthcare.
Gilead may be able to stretch supplies further than initially thought, however, and is actively experimenting with new formulations that would make remdesivir more accessible outside the hospital. Initial results from Gilead's SIMPLE trials indicate that a 5-day course of remdesivir may be just as effective for many patients as a full 10-day course, which could help stretch existing supplies. The full results from both trials have not yet been published in a peer-reviewed journal.
Trial results also indicate that the drug may be effective in moderately ill patients who do not require supplemental oxygen, potentially expanding the pool of patients who would benefit from treatment, though those patients are not currently included in the existing EUA. Based on those findings, Gilead recently announced that it is working on other formulations of remdesivir that could be administered more easily outside of the hospital than its current intravenous form, including a possible inhalable version.
"I understand this is a very fluid process," says Stefas of Northwell Health. "The more venues and avenues we have to access the medication the better."
Jillian Mock is a freelance science journalist based in New York City. She writes about healthcare, climate change, and the environment, and her work has appeared in many publications including the New York Times, Audubon Magazine, and Scientific American.
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Cite this: Most of Feds' Remdesivir to Be Distributed by End of Month - Medscape - Jun 16, 2020.