Gilead Drug Study Offers Promising Results Though Fauci Acknowledges It’s Not A ‘Knockout’ Punch

The Associated Press: A 1st: US Study Finds Gilead Drug Works Against Coronavirus
For the first time, a major study suggests that an experimental drug works against the new coronavirus, and U.S. government officials said Wednesday that they would work to make it available to appropriate patients as quickly as possible. In a study of 1,063 patients sick enough to be hospitalized, Gilead Sciences’s remdesivir shortened the time to recovery by 31% — 11 days on average versus 15 days for those just given usual care, officials said. (Marchione, 4/29)

The New York Times: Remdesivir Shows Modest Benefits In Coronavirus Trial
The improvement in recovery times “doesn’t seem like a knockout 100 percent,” Dr. Fauci conceded, but “it is a very important proof of concept, because what it has proven is that a drug can block this virus.” Sitting at Dr. Fauci’s side, President Trump said, “Certainly it’s positive, it’s a very positive event.” In past weeks, he has repeatedly hailed remdesivir as a potential “game changer,” despite spotty evidence. Business leaders, scientists and politicians alike are scrambling to find ways to fight an insidious epidemic and to reopen a devastated economy. The virus has claimed at least 60,000 lives in the United States, and more than 200,000 worldwide. There have been precious few reasons for optimism, and the markets seized on the news. (Kolata, Baker and Weiland, 4/29)

The Washington Post: Hopes Rise For Remdesivir, A Covid-19 Drug Therapy, As U.S. Passes 60,000 Dead
The study showed only a marginal benefit in the rate of death. Fauci said that a death rate of 8 percent for those taking the drug versus 11 percent for those taking the placebo is not statistically significant but that the results will undergo further analysis. The drug must be given intravenously over five to 10 days, and the NIAID trial results apply only to hospitalized patients. Remdesivir is not intended for use in the majority of patients, estimated to be 80 percent or more, who are infected with the novel coronavirus but do not require hospitalization. (Gearan, Rowland and McGinley, 4/29)

Reuters: Data On Gilead Drug Raises Hopes In Pandemic Fight, Fauci Calls It 'Highly Significant'
Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo, were hailed by Dr. Anthony Fauci as “highly significant.” “This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.” (Beasley and Mishra, 4/29)

ABC News: Trump, Fauci Tout 'Good News' From Remdesivir Drug Trial In Treating COVID-19 
The president, who in the past repeatedly encouraged COVID-19 patients to seek out a different, anti-malarial drug despite no strong evidence it helped, said that the results of the remdesivir trial were "good news." Trump has praised remdesivir in the past, too. "It's a beginning, it means you build on it," Trump said Wednesday. "I love that as a building block -- you know, just as a building block, I love that. But certainly it's a positive, it's a very positive event from that standpoint." (Gittleson, 4/29)

Reuters: Explainer: What Does New Data Say About Gilead's Experimental Coronavirus Drug?
The data also suggest a possible survival benefit with remdesivir, although the difference was not statistically significant, meaning it might have been due to chance and not Gilead’s drug. Comparing the drug to a placebo should give researchers definitive answers about remdesivir’s effect on the illness. While the study did meet its primary goal, the promising NIAID data are from an interim analysis. The trial’s final results will likely not be known until sometime next month. (Lapid, 4/29)

Politico: 'A Drug Can Block This Virus': Fauci Hails Covid-19 Treatment Breakthrough
Gilead said the data also suggests that people who received remdesivir early in their infection seemed to fare better than those that received it later. The study is not a traditional trial with a placebo arm to compare against remdesivir for effectiveness, earning Gilead some criticism from policy experts over sharing the news alongside the NIAID results. (Owermohle, 4/29)

The Wall Street Journal: U.S. Explores Emergency-Use Approval For Gilead Drug After Study Found It Helped Recovery From Covid-19
Federal health regulators are exploring whether to greenlight the emergency use of a Gilead Sciences Inc. drug in serious Covid-19 patients, after U.S. government researchers reported the therapy helped the patients recover faster. President Trump said he was pushing the U.S. Food and Drug Administration to grant the emergency-use authorization to the Gilead drug remdesivir. (Walker, 4/29)

Stat: Gilead CEO: We’re Going To Make Sure Remdesivir Is Accessible
On Wednesday Gilead Sciences, best known as a maker of HIV medicines, sent out a 177-word press release that led to a sigh of relief around the world: A study had shown that its experimental drug, remdesivir, had reduced the time it took for patients with Covid-19 to get better. The data were only preliminary, and many questions still remain, including the nature of the treatment effect in patients. But for Gilead’s chief executive, Daniel O’Day, it was a big moment. (Herper, 4/29)

NBC News: 'Clear-Cut' Evidence Coronavirus Drug Remdesivir Works, Fauci Says
Dr. Michael Saag, associate dean for global health at the University of Alabama at Birmingham, said the results seemed promising. Antiviral drugs such as remdesivir tend to work earlier in the course of an illness, so "the thing that I think is important in this study is the patients had advanced disease," said Saag, who is not involved with any remdesivir trials. "I think they were trying to give it the toughest test they could." (Edwards, 4/29)

Boston Globe: Coronavirus Patients Taking Gilead’s Remdesivir Recovered Faster 
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. (Saltzman, 4/29)

Reuters: WHO Declines Comment On Remdesivir In COVID-19, Hopes For Best
A top World Health Organization official declined comment on Wednesday on reports that Gilead Science’s remdesivir could help treat COVID-19, the respiratory disease caused by the novel coronavirus, but said that further data was needed. “I wouldn’t like to make any specific comment on that, because I haven’t read those publications in detail,” Dr Mike Ryan, head of the WHO’s emergencies programme, told an online briefing in response to a question, adding it can sometimes take a number of publications to determine a drug’s efficacy. (4/29)

Reuters: Fauci Says Leak Concerns Fueled His White House Revelation Of Gilead Drug Results
The dramatic announcement by Dr Anthony Fauci in the Oval Office on Wednesday prompted concerns among scientists that the Trump administration was raising hopes about a coronavirus treatment before sharing the full data with researchers. As a cautionary example of inflating the potential value of a therapy, some pointed to President Donald Trump’s repeated endorsements of malaria drug hydroxychloroquine as a treatment, with no evidence that it works. (Steenhuysen, 4/30)