Inadvertently Leaked Report Shows Gilead’s Promising Antiviral Drug Fails To Benefit COVID-19 Patients
Gilead spokesperson Amy Flood said the company believes “the post included inappropriate characterization of the study" because it was stopped early due to the fact that it had too few patients. The experimental drug remdesivir has been viewed as a frontrunner in the race to find a successful treatment for COVID-19.
Stat:
New Data On Gilead’s Remdesivir, Released By Accident, Show No Benefit For Coronavirus Patients. Company Still Sees Reason For Hope
The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit.” A summary of the study results was inadvertently posted to the website of the World Health Organization and seen by STAT on Thursday, but then removed. (Silverman, Feuerstein and Herper, 4/23)
Politico:
WHO Data Leak Shows No Benefit From Gilead Coronavirus Drug
The draft documents posted to the WHO website — and then quickly removed — suggest that the drug did not help patients enrolled in a randomized clinical trial in China, and caused significant side effects in several people that led them to end treatment. More participants who received remdesivir died compared to those in the control group, although the difference between the two groups was not statistically significant. Gilead thinks the results were mischaracterized because the study ended early due to low enrollment, spokesperson Sonia Choi said. "As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease." (Owermohle, 4/23)
In other news on treatments and vaccines —
The Wall Street Journal:
Lilly To Start Testing Experimental Drug In Coronavirus Patients Soon
Drugmaker Eli Lilly said it expects to begin human testing as soon as next month for an experimental Covid-19 treatment that uses antibodies derived from the blood of people who have recovered from the viral disease. The testing could yield results by late summer and, if successful, potential emergency authorization by the U.S. Food and Drug Administration by early fall, Lilly Chief Executive David Ricks said in an interview Thursday. (Loftus and Walker, 4/23)
Roll Call:
COVID-19 Vaccine Development Raises Numerous Questions
As scientists race to find a COVID-19 vaccine, policymakers and regulators face challenging questions including how to balance efficacy demands with a tight timeline, plans to pay for a potential vaccine and the best way to distribute it. Public health experts have indicated that a COVID-19 vaccine, which will take at least a year to 18 months to develop, is important for a return to normalcy. Last week, the National Institutes of Health announced an initiative to increase collaborative efforts to develop a vaccine and treatments for the COVID-19 pandemic. (Raman, 4/23)