Positive Signs Emerge From Patients Given Gilead’s Remdesivir, But Good News Muted By Limited Scope Of Trial
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, of the University of Chicago, in a video obtained by Stat. The antiviral had been singled out in the early days as one that might offer the most hope as a coronavirus treatment. But the trial does not include what's known as a control group, so it will be difficult to say whether the drug is truly helping patients recover better. In other pharmaceutical news: the dangerous rush to approve hydroxychloroquine; a look at where all treatment studies stand; herbal remedies growing in popularity; and more.
Reuters:
Report Says COVID-19 Patients Respond To Gilead's Remdesivir, Shares Surge
Gilead Sciences Inc’s shares surged 16% in after hours trading on Thursday following a media report detailing encouraging partial data from trials of the U.S. company’s experimental drug remdesivir in severe COVID-19 patients. (4/16)
Stat:
Gilead Data Suggests Coronavirus Patients Are Responding To Treatment
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease. The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir. (Feuerstein and Herper, 4/16)
CNN:
Report: Covid-19 Patients Recovering Quickly After Getting Experimental Drug Remdesivir
However, the trial does not include what's known as a control group, so it will be difficult to say whether the drug is truly helping patients recover better. With a control arm, some patients do not receive the drug being tested so that doctors can determine whether it's the drug that is really affecting their condition. Trials of the drug are ongoing at dozens of other clinical centers, as well. Gilead is sponsoring tests of the drug in 2,400 patients with severe Covid-19 symptoms in 152 trial sites around the world. It's also testing the drug in 1,600 patients with moderate symptoms at 169 hospitals and clinics around the world. (Fox, 4/17)
Reuters:
Exclusive: FDA May Have Dropped Standards Too Far In Hunt For Chloroquine To Fight Coronavirus - Sources
On March 21, two days after President Donald Trump first touted chloroquine drugs as a “gamechanger” in the fight against COVID-19, administration officials privately described what they felt was a “win” in the president’s efforts to build an emergency stockpile of the drugs: a hefty donation of pills from Bayer AG. (Eban, 4/16)
NBC News:
Family Of New York Woman Blames Hydroxychloroquine Combo For Fatal Heart Attack
A New York woman with coronavirus symptoms died last week after being prescribed a drug cocktail with known cardiac side effects, and family members say she was not tested for COVID-19 or for heart problems before receiving the medication. The family’s experience suggests that at least some physicians are prescribing hydroxychloroquine and azithromycin — drugs President Donald Trump has promoted to treat the coronavirus — outside of hospital settings, underscoring why major medical organizations including the American Heart Association have issued warnings about the drug’s potential to trigger heart arrhythmia in some patients. (Przybyla, 4/16)
The Washington Post:
Despite Trump’s Boosterism, There Is No Silver Bullet In The Pipeline Against Covid-19
The journey of EIDD-2801, from laboratory to the mouth of a human, unfolded with head-snapping speed. On March 23, a division of Emory University in Atlanta licensed the experimental drug to a Miami company owned by a wealthy hedge-fund manager and his wife. Just three weeks later, a pill was given to a person for the first time in a test of its safety, in Britain. (Rowland, 4/16)
The Hill:
STD Antibiotic Faces Shortages After Trump Promotes It As Coronavirus Treatment
A commonly prescribed antibiotic used to treat sexually transmitted infections and other conditions is facing a shortage after President Trump promoted it as a potential coronavirus treatment. Demand for azithromycin tablets — better known by its brand name Z-Pack — is soaring as the number of COVID-19 cases continues to rise in the U.S. (Hellmann, 4/16)
The Associated Press:
Some People Turn To Herbal Medicine For Virus Without Proof
With no approved drugs for the new coronavirus, some people are turning to alternative medicines, often with governments promoting them. This is most evident in India and China, densely populated countries with a deep history and tradition of touting such treatments, and where there’s sometimes limited access to conventional medicine. (Ghosal and Wang, 4/17)
Kaiser Health News:
With Federal Nod, Consumers Could Lose The Boost They Get From Drug ‘Coupons’
Patients who get financial help from drug companies to cover their copayments for prescription drugs could owe a bigger chunk of their costs under a proposed federal rule. The annual rule, which sets a wide range of standards regarding benefits and payments for most health plans for next year, would allow employers and insurers to decide that drug companies’ assistance doesn’t count toward their members’ deductible or out-of-pocket maximum spending limits. (Andrews, 4/16)
