Today Gilead Sciences (NASDAQ: GILD) was making a splash about their phase 3 trial results but all this trial essentially did was confirm that 5 or 10 days of remdesivir had similar efficacy. There was no control group in this 397 patient study. This clinical trial was designed to help determine a treatment protocol should remedesivir prove to be safe and effective in clinical trials. When there are no approved treatment options drugs like remdesivir that cause multi-organ failure in 25% of the population are considered “relatively safe.” GILD also announced there was also another study from the National Institute of Allergy and Infectious Diseases (NIAID) with details forthcoming. Fauci shared details with CNBC reporter Meg Tirell
Little Benefit for Late Stage Patients
Remdesvir is a drug with known side effects so a more lengthy exposure is not as advantageous. The study did conclude that “no new safety signals were identified with remdesivir across either treatment group.” According to GILD’s Chief Medical Officer Merdad Parsey, this study was primarily about
“attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug.”
This is one of multiple studies trying to figure out the optimal treatment regimen. Ruling out a 10-day treatment cycle was good news for GILD which had a limited supply of the drug but it also exposed a gaping hole in their theory to treat the disease. Remedsivir is a broad spectrum viral inhibitor and the fact that it only works for 5 days suggests there is little benefit to later stage patients that have overcome the viral load, but progressed to Acute Respirtatory Distress Syndrome (ARDS).
Viral Load Hardly Making a Dent
When looking at the viral load of remdesivir to the control. It barely helps the patient but it may be just enough to improve the patient’s recovery by a couple of days. A couple of days is NOT a game changer.
Prolonged Remdesivir Use Slows Recovery
The study also assessed clinical improvement of two or more from baseline on a seven-point scale ranging from hospital discharge to increasing levels of oxygen support to death. The focus or endpoint was on the discharge rate from the hospital in 14 days. Anecdotally the 10-day treatment group fared slightly worse than the 5 day treatment group. Given the known side effects of multi-organ dysfunction syndrome, septic shock, acute kidney injury, and liver damage, it’s reasonable to conclude that side effects may have had a role in a prolonged recovery.
SIMPLE CLINICAL TRIAL RESULTS
“In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.”
Exploratory Study Showed Early Treatment Works Better
An exploratory finding of the study was that earlier administration had improved outcomes. The study classified treatment within 10 days of onset and after 10 days of onset. The study found out that if treated within 10 days 62% of patients were discharged on day 14 versus only 49% of patients that were treated late.
Mortality Rate Disappoints
The 14 day mortality rate in the SIMPLE clinical trial was 8% for the 5 day group versus 10.6 for the 10 day group for an average of 9.3%. Fauci reported that the NIAID study was 8% vs 11% placebo assuming he used 14 days. He said the mortality benefit of remdesivir
“has not yet reached statistical significance.”
Fauci indicated the time to recover a vital endpoint was 11 days on remdesivir versus 15 for placebo. This was statistically relevant and the reason Fauci was quoted as saying remdesivir has a
“clear-cut, positive effect in diminishing the time to recover.”
These $10 billion lifts on GILD initially from STAT and now Fauci demonstrate what a solution is worth, but remdesivir is not the solution and will not be the “standard of care” despite what Fauci professed to Meg Tirell today. Investors need to see these results through the proper lens. An antiviral is not the solution. The problem stems from the cytokine storm and that is what is killing people. The change in mortality in these “severely ill” patients is not statistically relevant and will not allay peoples fear of dying. The safety profile of remdesivir is manageable with medication and adjustment to the protocol but does that mean we should treat people with a drug that could debilitate people. There is a trade off for quality of life and there is enough information to rationally say that remdesivir is not going to be a panacea for late stage patients and not doing that great of a job getting people out of the hospitals. Currently only one drug exists that can stop mortality, is virtually devoid of side effects, works in days, and completely quiets the cytokine storm and has 40,000 vials waiting for just one person at the administration to stray away from their love affair with remdesivir. If just one White House Press correspondent asked about leronlimab which is made by CytoDyn Inc. (OTCMKTS: CYDY) then perhaps we can turn the tide of the pandemic.
The solution is at hand. Prepared to be outraged that results like this are commonplace yet emergency approval of leronlimab is not at hand.
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Disclosure: Insider Financial and its owners do not have a position in the stocks posted and have posted this article for free without editorial input. This article was written by a guest contributor and solely reflects his opinions.