The drug Remdesivir keeps on grabbing the headlines.
A John Hopkin’s guide written by physician Paul G. Auwaerter in 2020 April suggested it was one of the most promising treatments for CoviD-19.
It is also part of WHO’s Solidarity Trial and Europe’s Discovery Trial.
What do we know so far about this antiviral?
Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences.
It is administered intravenously and was originally meant to treat Hepatitis C, Ebola and the Marburg virus but studies proved it was significantly less effective than other potential drugs for these diseases.
Amid the COVID pandemic, it has since been repurposed to combat SARS-CoV-2, the virus that causes COVID19.
“Remdesivir is an anti-viral drug administered by IV. It’s known as a nucleoside analog, meaning it mimics a component of viral RNA that the virus needs to replicate itself,” Annie Luetkemeyer, an infectious disease specialist was quoted by University of California San Francisco to have said in an article on its website.
Luetkemeyer is leading the COVID-19 clinical trials at UCSF and Zuckerberg San Francisco General Hospital and Trauma Center, the article added.
“Remdesivir is basically faking the virus into thinking it’s a building block of viral genetic material,” another infectious diseases specialist Peter Chin-Hong was quoted to have said in the same article
It is a viral RNA polymerase inhibitor which is basically a medicine that interferes with the production of viral genetic material.
The drug does this by first transforming into an active metabolite (GS-441524 mono-phosphate) and that metabolite subsequently inserts itself in the RNA chains of SARS-CoV-2 as it replicates.
This disrupts, delays or inhibits the process of viral replication ultimately preventing or decreasing the amount of the virus being multiplied.
FDA has since approved the drug for further “compassionate use”. It said on May 2020 that it is “reasonable to believe” that known and potential benefits of remdesivir outweigh its known and potential risks in some specific populations hospitalized with severe CoviD‑19 – but further research into the drug revealed that there has yet to be definitive evidence that Remdesivir reduced the mortality of CoviD-19.
Gilead began lab testing remdesivir against SARS-CoV-2 in January 2020, citing several researches including the Prophylactic and therapeutic remdesivir treatment in the rhesus macaque model of MERS-CoV infection by Emmie Dewit and co-authors that showed reduction in clinical signs and virus replication in the animals.
Another research by Timothy Seahan saw a similar trend on reduction in clinical signs and viral load with Remdesivir. Both researches suggests that it may possibly be used for coronavirus infections (SARS, MERS and SARS-CoV-2), which led to further trials. [READ: The CoviD-19 saga: Coronavirus’ Exorcism, The Wait for a Vaccine and our Salvation (Pt.1)]
But a trial in China, from February 6 to March 12, 2020, which was subsequently published in the medical journalLancet, suggested remdesivir was not associated with statistically significant clinical benefits.
However, though there was numerical reduction in time to clinical improvement in those treated, it requires confirmation in larger studies. Note that this trial was terminated because patients acquired various adverse effects on treatment.
Separate trials underwent in the US that also started in February 2020.
On April 2020, According to their National Institute of Allergy and Infectious diseases (NIAID), preliminary data from an international multi-center, placebo controlled double-blind randomized controlled trial (named “Adaptive COVID-19 Treatment Trial” or ACTT) suggests that remdesivir is effective in reducing the recovery time from 15 to 11 days in people hospitalized with CoviD-19. NIAID added that remdesivir was better than a placebo in reducing time to recovery for people hospitalized with advanced CoviD-19 and lung involvement.
The study subsequently appeared on The New England Journal of Medicine website on May 2020, and despite generally positive results, the study concluded that “given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”
The previous Chinese trials were criticized as underpowered due to a lack of significant results as well as the fact that the study was ended prematurely, in contrast, controversy (and a lot of ethical debates) also plagued the US health authorities when it stopped the ACTT trial and instead provided remdesivir to all participants (including those supposed to receive a placebo) which ultimately stops the study from getting any significant data about remdesivir’s effectiveness as all data is lacking conclusive evidence.
The European Medicines Agency started reviewing available data on remdesivir treatment in CoviD-19 and has since completed it in May 2020 with an additional update this month (June 2020) suggesting that they support the development of medicines that address unmet medical needs of patients.
It additionaly states that in the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required, based on the scope and criteria defined in legislation and guidelines.
Since then, Gilead announced that it had granted non-exclusive voluntary licenses to five generic drug companies to manufacture remdesivir for distribution to 127 countries. The agreements were structured so that the licensees can set their own prices and will not have to pay royalties to Gilead until the WHO declares an end to the COVID-19 emergency or another medicine or vaccine is approved for COVID-19, whichever comes first. The pharma companies in question are in India and Pakistan.
WHO SHOULD HAVE REMDESIVIR?
The question of many is: who should take Remdesivir? When is it available to us? When is it available in our country? Can it be bought? Who will distribute it? etc.
Access to the drug has been limited, as it is still an investigational drug. Investigational drugs vary from being approved by the FDA for only one type of disease and no other or is only limited to clinical trials.
Basically it is not a drug that is widely distributed to the public yet.
Remdesivir is available for “compassionate use” which by definition is the use of an unapproved drug or medical device outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress, and that may benefit from the said drug.
Recently the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended expanding the compassionate use of remdesivir to those not on mechanical ventilation, as it was initially limited to those in mech-vents.
This was based on the updated recommendations of the most recent researches mentioned above.
As for the Philippines, Remdesivir will be limited to patients who have enrolled in WHO’s solidarity trials.
Based on the reports of the National Health authorities, 117 patients registered in 15 study sites (14 hospitals in NCR and one in Davao).
WHO has provided the country with complete doses of Remdesivir for patients that may be eligible to join the trial. Basically it is still not available for the public, and there’s no estimated time when this will be.
So, is Remdesivir the cure we are waiting for?
As much as I want to say yes, currently, it is not. Not yet, at least. The best we could do is to hope that it is.
And as much as we’d want to celebrate the various advancements in medicine in light of the current pandemic, prevention is always better than cure. And there are some countries who excelled in prevention methods as even without these potential cures publicly available, they’re beating the disease, making their wait at ease.
While most, including us are clocking in cases and deaths each day (25,930 cases and 1088 deaths as of this writing) putting us in a position that can be described as desperately waiting for a cure, literally and figuratively. [READ: The CoviD-19 saga: Coronavirus’ Exorcism, The Wait for a Vaccine and our Salvation (Pt. 2)]