Gilead suspense: "Positive data" from trial of remdesivir on coronavirus patients by Fauci's agency is coming today; Update: Fauci reveals results; Update: Video

We’re ping-ponging between good and bad news about this drug. Two weeks ago the results leaked from a study of remdesivir at the University of Chicago, with the head researcher touting wonderful outcomes. But some scientists were skeptical, noting that that wasn’t a clinical trial. Clinical trials have control groups; the Chicago study had none, so it was impossible to say if patients who recovered did so because of the drug or irrespective (or in spite) of it.

Then came news that a clinical trial conducted in China showed no benefit from remdesivir, with a slightly higher mortality rate among patients who received it than among those who didn’t. Gilead piped up afterward to say that we shouldn’t draw conclusions from that trial since it was stopped early, with too few patients enrolled. What’s more, the company added, “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.” But they didn’t say which data.

Is this it?

There are two studies of remdesivir out today — or rather, there will be soon. One comes from Gilead itself and looked at whether a longer course of treatment with the drug (10 days) might have greater benefits than a shorter course (five days). Interestingly, the answer was no. Five days may be enough for maximum impact. But that study comes with a caveat: It too lacked a control group. The other study, which hasn’t been released yet, is newsier. That one was conducted by Anthony Fauci’s agency, the NIAID, and it did involve a control group. Gilead isn’t spilling the beans about the results but they’re clearly encouraged by the findings. The NYT reports that NIAID expects to make an announcement later today … possibly at the daily White House coronavirus task force briefing. Is Fauci himself going to do it?

Gotta think the results are pretty happy if he’s going to front them personally on national television. Until then, here’s what we know:

A government-run study of Gilead’s remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus…

[T]he NIAID study, which was not expected to be released so soon, was by far the most important and rigorously designed test of remdesivir in Covid-19. The study compared remdesivir to placebo in 800 patients, with neither patients nor physicians knowing who got the drug instead of a placebo, meaning that unconscious biases will not affect the conclusions.

The main goal of the study is the time until patients improve, with different measures of improvement depending on how sick they were to begin with. While the result means that the drug helps patients improve faster, it is not possible to say how dramatic those improvements are.

A drug that helps patients with mild cases recover faster would be useful even if it ends up having little or no impact on fatalities in more severe cases. Faster recoveries for mild cases mean more hospital capacity and less time spent out of work for those who are sick. But a drug that helped patients with mild cases recover faster *and* meaningfully reduced fatalities would be momentous potentially. That’s what I want to hear from Fauci: Is there evidence that early treatment with remdesivir prevented mild cases from becoming severe ones? How did it fare on cases that were already severe?

I hope the staff at Stat isn’t overhyping it:

As for Gilead’s own study, Politico has details:

Gilead released its own study results this morning suggesting that severely ill patients receiving five days of remdesivir fared just as well as patients receiving a 10-day dosing regimen. More than half of both dosing groups were discharged from the hospital within two weeks of beginning their medication.

Eight percent of people in the five-day group died while 11 percent in the 10-day group died. But another 10 percent in the longer dosing arm had to discontinue treatment because of serious side effects, and the study lacked a control group.

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.

A short hospital stay may work as well as a longer one (if not better) to benefit from the drug, which is great news if it holds up in a randomized clinical trial. On the other hand, as far as I know, remdesivir is administered only via IV. There’s no scenario in which people contract the virus, fill a prescription at CVS, and then pop it as a pill for a week to get better. It’s a drug for those whose symptoms have already reached a point of sufficient severity that they need medical assistance. But that doesn’t mean it won’t end up saving a lot of lives if it works.

The FDA is ready to move quickly:

Scott Gottlieb is still holding out hope for antibody treatments as a potential silver bullet against COVID-19 more so than remdesivir but we’ll take anything we can get in the meantime that might make economic activity less life-threatening. As for why remdesivir is being so closely watched, I found this piece enlightening. It’s not just that the drug might be available near-term, to make an immediate impact on the epidemic. It’s the fact that scientists believe it *should* work on coronavirus because of how it functions. It successfully inhibits replication of viruses in the lab. It successfully inhibits replication of viruses in monkeys. If it doesn’t successfully inhibit replication of COVID-19 in humans, researchers will be left at a loss for how to deal with the virus: “If remdesivir fails what in the world is going to succeed? The malaria drugs never had a chance from the get-go. The AIDS drugs were a stretch, but everything about remdesivir makes sense, except the outcome.” The “outcome” referred to was the incomplete Chinese trial I mentioned up above. Sounds like today’s outcome will be better.

Update: Fauci’s previewing the results of the NIAID trial at today’s pool with reporters. The improvements with remdesivir seem pretty modest to my untrained eye, but he sounds excited.

It’s better than nothing, adds Scott Gottlieb:

Update: Here’s the video.