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Coronavirus patients taking Gilead’s remdesivir recovered faster

Data from study of California company’s medicine could lead to emergency approval from the FDA.

The Gilead headquarters in Foster City, Calif.
The Gilead headquarters in Foster City, Calif.David Paul Morris/Bloomberg

A closely watched clinical trial has turned up a glimmer of good news in the race to find a treatment for COVID-19, in the form of preliminary data showing that Gilead Sciences’s experimental drug remdesivir helped severely ill patients recover faster in the hospital.

The news came as the state reported the largest single-day increase of deaths from the outbreak, a rise of 252 fatalities to a total of 3,405.

But the results of the clinical trial — even this very early snapshot — drew attention at the White House and helped spur a rally on Wall Street, buoying hopes at a time when every day is bringing more heartbreaking news.

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The National Institute of Allergy and Infectious Diseases said Wednesday that patients who received remdesivir recovered 31 percent faster than those who got a placebo in the government-run trial. The median recovery time was 11 days for patients who received remdesivir compared with 15 days for those who were given a placebo.

“Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Dr. Anthony Fauci, director of the institute, said at the White House. “This is very optimistic.”

The trial also suggested that remdesivir, which is made by Foster City, Calif.-based Gilead, might improve prospects for survival. Eight percent of the 1,063 patients with severe lung disease from coronavirus who received the drug died, compared with 11.6 percent who took a placebo.

That difference wasn’t statistically significant, Fauci said. But overall, he said, the early findings were so encouraging that he was morally obliged to make them public before they were completely analyzed.

“Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know so that they can have access, and all of the other trials that are taking place now have a new standard of care,” he said.

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Fauci likened the data to that from a 1986 trial of the antiretroviral drug azidothymidine, or AZT, as a treatment for HIV. Fauci, whose AIDS research catapulted him to fame after he became director of the institute in 1984, said AZT provided modest benefits to patients but led to better drugs..

Some health experts, including Dr. Scott Gottlieb, former commissioner for the Food and Drug Administration under President Trump, were already recommending that the agency grant an emergency use authorization to make the drug available.

Trump, who was present when Fauci discussed remdesivir at the White House Wednesday, called it a “very positive event.”

“I think it’s a beginning,” he said. “I thought Tony explained it really well. It’s a beginning. It means you build on it.”

Massachusetts General Hospital was among 47 sites nationwide that participated in the study. There were also 21 sites in countries in Europe and Asia, according to NIAID.

Gilead mentioned the NIAID study earlier on Wednesday, prior to the release of the preliminary data, and also shared results from its own late-stage trial of remdesivir in patients hospitalized with COVID-19. That study showed that patients treated for five days with the yet-to-be-approved medicine and those treated for 10 days with it had similar rates of improvement.

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If a shorter course of treatment works as well as a longer one, that might enable doctors to make the drug available to more patients, said Dr. Merdad Parsey, chief medical officer for Gilead. A shorter course would mean there would be more of the medicine to go around.

“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic,” he said. “Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug.”

Parsey said the company’s own results complemented the NIAID data and would help determine the optimal length of treatment with remdesivir.

In recent weeks, there have been conflicting reports about the potential benefit of the drug, a broad-spectrum antiviral that yielded lackluster results when used to treat people with the Ebola virus. An early glimpse of Gilead’s study in severe COVID-19 patients, based on data from a trial at a Chicago hospital and recently reported by STAT, suggested that patients did better than expected on remdesivir.

Days later, however, a summary of results from a study in China that was inadvertently posted to the website of the World Health Organization showed that patients on the drug did not improve more than those who received a placebo.

Dr. Libby Hohmann, a principal investigator at the trial site at Mass. General, told the Globe last week that 49 COVID-19 patients hospitalized with severe lung problems participated in the study at her hospital. About half received remdesivir, and the other half got a placebo.

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Although neither she nor the patients knew what they got, Hohmann said she saw signs that led her to suspect the drug helped seriously ill patients, especially if given early enough.

“I have some people who seemed to get significantly better and went home quickly,” said Hohmann, an associate professor of medicine and infectious diseases at Harvard Medical School. “And I also have patients who did not seem to improve and had a long ICU stay.”

Remdesivir has shown promise in test tube and animal studies on other coronaviruses such as SARS and MERS. But the results were disappointing when it was used to treat Ebola patients, according to a 2018-19 study published in December in the New England Journal of Medicine. It has yet to be approved for any use.

There is no approved treatment for coronavirus, and a vaccine is expected to take at least 12 to 18 months to be developed and tested. In the meantime, scientists have been running clinical trials on a number of potential therapies, with remdesivir among the most closely watched.

Remdesivir is given intravenously and is designed to interfere with an enzyme that reproduces viral genetic material. In animal tests against SARS and MERS, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness.

On Wednesday, Gottlieb, the former FDA commissioner, tweeted that the government should consider green-lighting remdesivir on an emergency basis. The New York Times reported that the White House was likely to issue an emergency approval for the drug.

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“As we’ve been saying for some time now, accumulating data on remdesivir suggests it’s active against covid and there’s now enough data to support consideration of access under an emergency use authorization by FDA,” Gottlieb wrote. “The data from NIAID study should push this firmly over the line.”

Gottlieb added that “the emergency use authorization would allow commercial distribution of remdesivir so more critically ill patients could get access now. Remdesivir would appear to meet or exceed standard for authorization under EUA, especially relative to other EUAs issued.”

But Dr. Nahid Bhadelia, an associate professor at the BU School of Medicine who specializes in infectious diseases, urged caution in a series of tweets.

“Today, Gilead released data on its trial w sick patients (no control) that showed outcomes same in 5 and 10 [days],” wrote Bhadelia, who also serves as medical director of the Special Pathogens Unit at the BU School of Medicine. “Gilead also preempted NIAID saying that the NIAID study (with control arm) met its primary outcome: time to recovery.”

She said the public should watch to see if “NIAID confirms positive results,” while referencing a “prior abstract that was released about the Chinese study with sicker patients that supposedly showed no mortality benefit but no one has yet seen the study. We need to look at results of this study when published as well.”

In addition, she said, the public also needs to look for results of Gilead’s study of moderately ill patients.

“Antivirals work better if given earlier in disease,” she tweeted. “We need to look at overall mortality benefit but also whether giving at a time point sooner in disease makes difference.”


Jonathan Saltzman can be reached at jonathan.saltzman@globe.com