A sign is posted in front of the Gilead Sciences headquarters on April 29, 2020 in Foster City, California. Gilead Sciences announced preliminary results of a drug trial with that showed at least 50% of patients with coronavirus that treated with a five-day dosage of remdesivir improved and more than half were released from the hospital within two weeks. (Photo by Justin Sullivan/Getty Images)
Virginia’s most recent allocation of remdesivir, currently the only drug with proven effects against COVID-19, is enough to treat roughly 36 people — about 3.5 percent of all hospitalized patients with confirmed cases of the disease.
The Virginia Department of Health received 10 cases of the drug on Monday, part of a larger shipment distributed by the U.S. Department of Health and Human Services through a donation from Gilead Sciences, the manufacturer of the experimental drug.
The company donated 607,000 vials of the medication to the United States after receiving emergency use authorization from the federal Food and Drug Administration on May 1. HHS will be distributing the donation over the next six weeks, according to a news release from the agency.
Cynthia Williams, the chief pharmacy officer for Riverside Health System in Newport News, said officials had to pivot quickly after HHS decided to distribute its second round of donations directly to state health departments. NPR reported Thursday that the agency’s first distribution left many health care providers confused on why the high-demand drug was routed to certain hospitals over others.
But there are no specifics yet on where Virginia’s few doses have been distributed. The Virginia Hospital and Healthcare Association worked with VDH to identify which hospitals would receive the medication, according to a fact sheet the agency sent the Mercury in response to a request for more information.
Nineteen hospitals were selected, said Julian Walker, the vice president of communications for the Virginia Hospital and Healthcare Association. But he declined to identify the specific facilities.
Tammie Smith, the VDH spokeswoman who responded to the Mercury’s request late on Wednesday, wrote Thursday that she had requested a list of hospitals to receive the drug, but could not immediately provide the names of the facilities or respond to additional questions about the shipment.
Responses also varied by individual hospital. VCU Health, one of three hospitals reached by the Mercury on Thursday, is expecting to receive “a small amount of remdesivir” from VDH on Friday, according to Mary Kate Brogan, a spokeswoman for the health system.
Williams confirmed that Riverside did not receive doses from the allotment. Sentara Healthcare, a Norfolk-based health system with 12 hospitals stretched across southern Virginia and northeastern North Carolina, would not answer any questions about the shipment.
“We don’t wish to discuss anything about this topic,” spokeswoman Brittany Vajda wrote in an email on Thursday.
It isn’t clear if Virginia will receive a second allotment of the medication, which Williams said was largely routed to states based on the prevalence of COVID-19 patients. New York, for example, received 565 cases in the initial delivery from HHS, while Massachusetts received 117.
VDH wrote in its fact sheet that hospitals were chosen based on a selection model that took factors such as the number of coronavirus patients into account, as well “a hospital’s ability to support the clinical use of remdesivir as confirmed by an attestation form back to the state.”
Williams clarified that hospitals were asked to verify that they would use the drug as it was administered in a national trial — one that assessed whether remdesivir could improve outcomes for hospitalized patients with advanced COVID-19 and lung involvement.
Inova Health, a hospital system based near Fairfax County, was not included in what VDH later called a “lottery system” because it received its own supply of 33 cases directly from HHS.
Each case contains 40 vials with 100 milligrams of the medication, according to the VDH fact sheet. The drug is administered over a 10-day treatment period, according to the National Institute of Allergy and Infectious Diseases.
Remdesivir, a previously little-known antiviral, attracted nationwide attention in late April when NIAID announced that the medication shortened the recovery time for patients hospitalized with advanced stages of COVID-19. Director Anthony Fauci compared the results of the randomized controlled trial to the discovery of the first drug to help patients with HIV.
He later warned that the drug had modest effects — shortening recovery time to a median 11 days for patients who took the drug, versus 15 days for those who took the placebo. But Dr. Benjamin Van Tassell, vice chair for clinical research in VCU’s Department of Pharmacotherapy and Outcomes Science, said the results were significant largely because remdesivir succeeded where other once-promising drugs had failed.
“It is the only drug that has compelling evidence to suggest it can even make a dent in this disease,” said Van Tassell, who helped launch VCU’s clinical trial of the medication.
Other medications, including hydroxychloroquine, the anti-malarial drug repeatedly touted by President Donald Trump, have shown lackluster results during in-patient trials. Hydroxychloroquine, especially, can cause significant heart problems while having little effect on the virus.
While some trials for the drug are still ongoing, including a recently launched NIAID study, Van Tassell said many researchers are turning to anti-inflammatory medications — including tocilizumab, a drug usually used to treat rheumatoid arthritis — in an effort to alleviate the overactive immune response that might cause or complicate severe forms of COVID-19.
“To this day, remdesivir is the only antiviral medicine that can really slow down the life cycle of the virus itself,” Van Tassell said.
That makes the drug especially desirable as hospitals across Virginia race to respond to severe cases of COVID-19. Outside the HHS shipments, Williams said remdesivir is only available through clinical trials — which NIAID largely halted after initial results showed the drug benefited patients — or by applying to Gilead through its expanded access program.
The company used to offer limited doses of the drug through compassionate use requests, with an emphasis on pregnant women, children and severely ill patients. Williams said Riverside was able to obtain enough remdesivir to treat a single patient earlier in the pandemic through the previous program.
Gilead recently phased out compassionate use and plans to “wind down” its expanded access program in the U.S. over time, according to the company’s website. Williams said remdesivir isn’t expected to become commercially available until late summer as the company continues to increase its supply.
“We know there’s not going to be adequate supply of this drug probably until later this year,” she added. “Even when Gilead ramps up its production, I think there’s still the concern of whether it will be enough, depending on where we are in the pandemic.”
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