There has been a flurry of Gilead news today.
- Gilead announced their company sponsored remdesivir data for severe COVID patients.
- Gilead said the government-run NIAID trial evaluating remdesivir in COVID patients met the study's primary endpoint.
- The Lancet published more data from remdesivir China placebo controlled study
#1: Gilead’s Single Arm Data Shows 5-Day Regimen Is Good Enough
Starting with #1 above, Gilead announced their company sponsored remdesivir data for severe COVID patients this morning. The study compared treatment with remdesivir between 5-day and 10-day course. Gilead’s goal was to show that there was non-inferiority (5 day treatment was not inferior to 10 day).
Remember that this data is from an open label, single arm study. Without a control comparator arm, there can be no conclusive evidence that remdesivir actually worked. That means reported data is at least partly anecdotal.
What Did Data Show
There was no significant difference between 5 and 10 days of treatment. This means that Gilead can focus on 5-day regiments without worrying about the outcome being affected by longer treatment course.
In the 5-day group, 60% (n=120/200) of patients were discharged by Day 14. In the 10-day group that number was 52% (n=103/197). In total 56% of patients were discharged (223/397) by Day 14.
The overall mortality rate at Day 14 was 9% (n=37/397) across both treatment groups.
This data did not include patients who were on ventilation at screening, although they may have been put on subsequently. There was no breakdown of oxygen support.
The closest comparable data set we can use is the NEJM remdesivir data and this reported data set was similar. Discharge was 47% in NEJM vs 60% here. Mortality was 13% in NEJM vs 9% in this dataset. However, it is hard to interpret this cross-trial data since no information of baseline, viral load or patient breakdown is given.
#2: Government Run Placebo Controlled Study Meets Primary Endpoint
Minutes before the single arm data (above) was released, Gilead also said that the government-run NIAID trial evaluating remdesivir in COVID patients met the study's primary endpoint. No additional data was released by Gilead. This is the most important remdesivir study because it is also placebo controlled.
The National Institute of Allergy and Infectious Diseases (NIAID) director is Dr. Fauci, who has been present in many of the White House briefings. NIAID is sponsoring remdesivir in all COVID patients (mild, moderate, severe).
What we know from this trial is that patients on:
- remdesivir improved after 11 days vs 15 on placebo (p<0.001)
- mortality on reddesivir was 8% vs 11% on placebo (p=0.059)
#3: Remdesivir China Data Published in The Lancet
Last week, WHO leaked placebo controlled remdesivir data from a Chinese trial. This leak showed that remdesivir was not associated with clinical or virological benefits. The Lancet published this full data set and it showed that in 237 patients:
There was no statistically significant clinical benefits between remdesivir and control, as see below p=0.24. 
Additionally, there was no statistically significance difference in viral load reduction between remdesivir and control.
This data is not supportive of remdesivir, as it did not significantly improve clinical benefits or clearance of virus compared with placebo.
Arguments can be made that because the trial was terminated prematurely and did not enroll the initial expected patients, it was underpowered to detect assumed differences in clinical outcomes. Additionally, there were multiple background meds given with remdesivir, which clearly will affect outcomes.
Just like in the Gilead sponsored data, this Chinese data has flaws that make data inconclusive.
Main Takeaways:
- Remdesivir as 5-day regimen worked in line with 10-day regimen.
- A separate NIAID placebo-controlled study hit primary endpoint. More data coming likely this afternoon during White House briefing.
- With NIAID’s data and seemingly positive analysis, Gilead seems to be on track for FDA approval.
- Gilead will see immaterial financial impact from remdesivir. Compare ~$1B in remdesivir revenue to Gilead’s $20B annual revenue.
- There will be a much greater impact on broader economy and sentiment. With an approved treatment that improves COVID outcomes, risks to resuming regular life/economy are lessened.
PropThink contributors hold NO POSITIONS in GILD.
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