Patients sick with COVID-19 who received the experimental drug remdesivir recovered more quickly than those who did not in a government-sponsored clinical trial, the National Institutes of Health announced Wednesday, raising hopes that the pandemic's impact could be blunted.
Patients treated with remdesivir recovered in an average of 11 days, four days more quickly than patients being treated with a placebo, a study of 1,063 people found.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci acknowledged that the shortened recovery time may not seem like a “knockout” breakthrough in combating the pandemic. But he described the findings as significant in showing that antivirals can be effective against the coronavirus that causes COVID-19.
“Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept,” Fauci said in the Oval Office on Wednesday. “Because what it has proven is that a drug can block this virus.”
The pandemic has claimed 58,524 lives in the U.S., according to the Johns Hopkins Coronavirus Resource Center. There have been 1,015,123 positive cases in the United States alone, the largest number in any country and about one-third of the world's total.
Fauci said the agency plans to build on the results in the same way that more effective treatments grew out of AZT, an early HIV/AIDS drug, when treatments for that epidemic were desperately needed.
The study was a randomized, double-blind, placebo-controlled clinical trial, the gold standard for measuring the safety and efficacy of drugs. But the data analysis is preliminary. Fauci said he felt an ethical obligation to rush the results in order to make the drug available to patients on the placebo, and that the results will be submitted for peer review.
Former FDA Commissioner Scott Gottlieb, an unofficial but influential adviser to the Trump administration on the pandemic, renewed calls for an emergency use authorization in light of the new evidence to make the drug widely available in advance of full FDA approval.
"As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate," FDA spokesperson Stephanie Caccomo said.
The positive news was dampened somewhat by a study published in The Lanceton Wednesday.
Another randomized, double-blind, placebo-controlled clinical trial found that patients in China taking remdesivir recovered no sooner than patients taking the placebo.
The preliminary results of that study were briefly leaked on the World Health Organization website last week.
In the Lancet study, adverse side effects were reported at a rate of 66 percent among the remdesivir arm and 64 percent of the placebo arm.
The NIH has not yet reported data on side effects.
Shares of remdesivir's maker, Gilead, rose following the NIH’s announcement. The drugmaker’s stock has climbed since the coronavirus crisis began from $65 at the end of last year to $83 Wednesday.
Patient advocates cheered the results of the NIH study but raised concerns that remdesivir will not be affordable.
Gilead has previously been a target of patient advocates for its pricing of other drugs developed through public research, including HIV/AIDS treatment Truvada for PrEP. A 2018 CDC study found that approximately 1 million people at substantial risk for HIV were not filling prescriptions for PrEP.
Gilead also was known for the high price tags of its hepatitis C drugs Sovaldi, which launched at $84,000 per treatment and Harvoni, which launched at $94,500 per treatment.
“This is great news. But based on Gilead’s record, we’re deeply concerned that they’ll use their monopoly control to price-gouge patients and make this potentially life-saving treatment unaffordable and inaccessible,” said Margarida Jorge, campaign director of Lower Drug Prices Now.