A leading medical journal recently published an analysis of coronavirus patients treated with remdesivir, an experimental antiviral from Gilead Sciences (NASDAQ:GILD). While the data doesn't tell us much that we didn't know already, it did pour cold water on any lofty expectations and highlight reasons drug developers generally avoid compassionate use programs.
The FDA allows drugmakers like Gilead Sciences to provide experimental treatments to patients with lethal conditions that lack treatment options. When patients can't access experimental treatments by participating in clinical trials, there's a compassionate use pathway that involves cooperation among patients, their physician, the FDA, a separate review board that advises the FDA, and finally the drugmaker.
Gilead Sciences has provided remdesivir to thousands of coronavirus patients outside controlled clinical trial settings through an expanded version of the FDA's compassionate use program. In a recently published analysis of 53 patients who received at least one dose of remdesivir, 47% were discharged from the hospital.
It's not over
It's hard to look at the reported 47% hospital discharge rate without feeling disappointed, but it's hardly time to throw in the towel on remdesivir. All we've learned from the study is that the experimental drug isn't super-effective when given to COVID-19 patients after they've landed in an intensive care unit. That said, there's also a strong chance that significantly fewer of these patients would have improved without remdesivir.
We know that antiviral drugs that stop viruses from replicating are more useful when administered in earlier stages of infection. Two-thirds of patients in the analysis were so severely affected that they had already started relying on ventilators to breathe for them before beginning treatment with remdesivir.
Later this month, Gilead Sciences will announce results from the first of several controlled clinical trials with remdesivir.