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President Donald Trump, who was hospitalized at Walter Reed National Military Medical Center on Friday following a positive coronavirus test, has begun receiving the intravenous antiviral drug remdesivir, which doctors have used to treat some cases of Covid-19.
White House physician Dr. Sean Conley has said the president has symptoms that include a low-grade fever, cough, congestion, and fatigue. He issued a memo late Friday saying that Trump “is doing very well.”
“He is not requiring any supplemental oxygen, but in consultation with specialists we have elected to initiate remdesivir therapy. He has completed his first dose and is resting comfortably,” reads the statement.
An update from President @realDonaldTrump’s physician: pic.twitter.com/8xzB8FShkd
— Kayleigh McEnany (@PressSec) October 3, 2020
Remdesivir is allowed for treatment under an emergency use authorization (EUA), which the Food and Drug Administration (FDA) grants for treatment of illnesses “when there are no adequate, approved, and available alternatives.”
It is not yet clear how severe Trump’s case is; though remdesivir is typically used for moderate to severe cases, it is possible Trump’s doctors are erring on the side of aggressively treating him, given his responsibilities as the leader of the United States.
Trump announced his diagnosis early Friday morning, and, not long after, received an initial dose of an experimental monoclonal antibody treatment. As Vox’s Umair Irfan has explained, the experimental treatment is currently undergoing testing in clinical trials conducted by Regeneron, a biotech company, but does not have authorization from the FDA.
Trump was authorized by doctors to use the monoclonal cocktail under compassionate use guidelines. Regeneron has said its research so far has found the treatment, known as REGN-COV2, to reduce symptoms and the presence of the virus in those with Covid-19. Regeneron’s research has yet to be peer-reviewed, Irfan notes, so it is difficult to know how well REGN-COV2 actually works.
For now, the president has only had a single dose of the experimental treatment before beginning the more routine treatment of remdesivir. Conley said Trump is also taking some vitamins and supplements, including vitamin D, which White House coronavirus task force member Dr. Anthony Fauci has recommended taking in order to reduce “susceptibility to infection.”
What we know about remdesivir and its effectiveness
It’s difficult to draw conclusions about how Trump is doing based on his course of treatment. Gilead, the pharmaceutical company that makes remdesivir, has recommended it for patients with moderate to severe cases of Covid-19, regardless of the need for supplemental oxygen.
When the FDA issued an emergency authorization of the drug back on May 1, it did so for patients with severe cases of Covid-19 — meaning those with low blood oxygen levels, who receive supplemental oxygen or are on a ventilator.
In August, the FDA said the drug did not need to be limited to only the most severe cases, and on Thursday, the FDA renewed the emergency authorization of the drug.
The drug is still pending formal FDA approval, since clinical trials to evaluate the drug’s effectiveness are still underway.
There have been several studies of the drug’s effectiveness for treating Covid-19, assessing how quickly a patient shows improvement while on the drug compared to receiving a placebo.
The results so far suggest it can reduce the duration of hospitalization by a few days for severe cases, but there’s insufficient evidence on whether it works in mild or moderate cases.
When remdesivir received its first emergency authorization in May, a National Institutes of Health clinical trial had just showed that severe patients recovered in 11 days in the course of its use, compared to 15 days for patients on a placebo.
Another clinical trial from Gilead showed that the average time to improvement was five days among those with mild and moderate cases of the disease, with no difference between those who were administered remdesivir and those receiving the placebo.
A third study found patients with moderate cases are 65 percent more likely to show improvement over using a placebo, when the treatment lasts for five days. That difference is erased when the treatment lasts for 10 days.
According to the health news website STAT, medical researchers have not been given access to Gilead’s raw research data to verify these clinical trials.
In a study published Saturday in the peer-reviewed medical journal The Lancet, the authors did not find a significant difference between patients with severe infections who used remdesivir and those on a placebo. The authors called these findings “disappointing,” and said the drug did not appear to lower viral load or mortality.
Remdesivir’s side effects are still being investigated as well. Gilead notes that “serious and unexpected side effects may happen,” including allergic reactions and changes to patients’ liver chemistry. The European Union is looking into whether the drug can cause kidney damage in some patients. Overall, Gilead has warned that remdesivir “is still being studied so it is possible that all of the risks are not known at this time.”
This therapy is not cheap. Private insurance will be billed $520 per vial, according to Gilead, and $390 per dose for those on some government health programs. For a five-day course of treatment, with a double dose on the first day, private insurers — as well as Medicare and Medicaid — will be charged $3,120. Government insurers, such as the Indian Health Service and the Department of Veterans Affairs, will be charged $2,340 per patient.
How much of those costs are passed on to the patient depends on their insurance plan.
A drug price watchdog group, Public Citizen, estimated that the drugmaker received $70 million in taxpayer dollars to develop the treatment, and called the subsequent pricing an “offensive display of hubris and disregard for the public.”
Gilead’s CEO has said this price is “well below the value” of the drug.
In July, the Trump administration worked out an agreement with Gilead that allowed the company to supply half a million treatment courses to US hospitals through September. And in October, the FDA said medical professionals could begin buying the therapeutic directly from Gilead. President Trump championed the drug’s use before needing, on Friday, to use it himself.
