Gilead Leads Development of a Possible Treatment for COVID-19

Coronavirus, it is everywhere. No doubt every channel on your TV has its two cents about how this pandemic is going, and all forms of social media are saturated with people finding a way to get away from the boredom of being quarantined in their houses. The virus originated from Wuhan, China and swept across the globe in a matter of months, changing everyone’s life as state and federal governments began issuing social distancing protocols and companies began implementing work from home mandates. Everyone has the same questions on their mind: when will this pandemic end? How long until we find a cure for COVID-19?

The term cure is very broad and can be associated with many things. The ideal cure would be a vaccine. That way, we can protect ourselves from ever becoming sick, and return to our lives before this pandemic. However, according to Anthony Fauci, a COVID-19 vaccine could take 12 to 18 months to be developed, tested, and approved for public use (1). For most Americans, the thought of being stuck at home for two months was bad enough, but 12 to 18 months may be enough to drive even the most introverted people crazy. However, the wait may be shorter than expected. Gilead Sciences, an American biotechnology company based out of California, has recently finished its Phase III clinical trials of its potential coronavirus treatment, Remdesivir. Remdesivir is a broad-spectrum antiviral that was originally developed to treat Ebola. It is designed to slow the infection of healthy cells by blocking viral replication by introducing faulty nucleotides into the replication space (2). This slows down the virus’s ability to multiply in the body and can lower the side effects felt by the infection. Current research shows that Remdesivir has the potential to utilize this to lead the fight against COVID-19. Researchers out of the International University of Kyrgyzstan have shown that GS-5734 (Remdesivir) inhibits replication in early stages by inhibiting the synthesis of viral RNA in older strains of coronavirus (3). Remdesivir holds the same promise in today’s pandemic due to high similarities in the genetic code between the coronavirus strain identified in 2002 and the current strain. The 2019 strain is approximately 79% similar to the 2002 strain and 96% similar to the coronavirus commonly found in bats.

Back in February of this year, Gilead initiated two, small scale, Phase III studies to test the safety and efficacy of Remdesivir (4). The data was recently released to the public in a statement made by the company. The study was done on a sample of 53 patients through the Gilead’s compassionate use program. All patients were initially hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). Approximately 75% of patients were men over the age of 60. The results show that 57% of patients on mechanical ventilators were extubated, and 47% of all patients in the study were discharged from the hospital after being treated with Remdesivir. In a follow up after 28 days, 84% of patients had either been discharged from the hospital or had shown a two-point improvement on a six-point scale (4). This indicates that there were positive results from the administration of the drug, but the sample size was only 53 patients, which makes it difficult to determine the significance of these results.

This leaves us with one question: where do we go from here? We have seen the stock market spike in response to the results, and there have been whispers and rumors in the media about beginning to draft plans for restarting the economy. As amazing as these results are, this does not mean it is time for everything to go back to normal. Remdesivir is only an experimental drug. Although the results from this study were promising, it has not shown to be effective enough to be cleared by the FDA for public distribution. Mordad Parsey, Chief Medical Officer at Gilead says, “While the outcomes observed in this compassionate use analysis are encouraging, the data are limited.” (4) More importantly, Remdesivir is only a treatment which has been tested on patients with extreme cases of coronavirus. There is no guarantee that after taking this drug you are no longer susceptible to the disease. There is also still no guarantee that you will be completely cured after taking the treatment. As Gilead finishes its analysis of its Phase III results, it will have to decide with the FDA as to whether it will repeat these Phase III trials or be given permission to move on to Phase IV. The important thing is that, as exciting as these developments are, there is still a long way to go before a treatment or a vaccine is available. We will have to band together if we want to survive this, and social distancing and proper hygiene have never been more important.

 Citations:

1. Lanese, Nicoletta. “When Will a COVID-19 Vaccine Be Ready?” LiveScience, Future US, Inc, 16 Apr. 2020, www.livescience.com/coronavirus-covid-19-vaccine-timeline.html.

2. “Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19.” Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19, Gilead Sciences, 26 Feb. 2020, https://www.gilead.com/.

3. Pagliarulo, Ned. “A Closer Look at the Ebola Drug That's Become the Top Hope for a Coronavirus Treatment.” BioPharma Dive, IndustryDive, 5 Mar. 2020, www.biopharmadive.com/news/coronavirus-remdesivir-gilead-antiviral-drug-covid-19/573261/.

4. Yethindra, Vityala. “Role of GS-5734 (Remdesivir) in Inhibiting SARS-CoV and MERS-CoV: The Expected Role of GS-5734 (Remdesivir) in COVID-19 (2019-NCoV) - VYTR Hypothesis.” International Journal of Research in Pharmaceutical Sciences, International Journal of Research in Pharmaceutical Sciences, Sponsored by JK Welfare & Pharmascope Foundation, 6 Mar. 2020, pharmascope.org/ijrps/article/view/1973.