“Government taking all steps to accelerate remdesivir production”
This is what the blaring headline of the Indian newspaper The Hindu reads: the actions of a government aiming to rid their country of COVID-19 once and for all. But the rapid production of this drug, as well as its global acceptance, raises some questions regarding its effectiveness as a ‘treatment’ for COVID-19. The drug’s aggressive use in countries like India and Singapore, where they have been given emergency use authorization, has led to many inquiries into its reliability. As of February of 2021, Remdesivir has been approved for emergency use in India, Singapore, and several more countries. It has also been approved to treat patients with severe symptoms in Canada, Japan, the EU, the USA, and Australia.
The rapid research, testing, production, and distribution of many SARS-CoV-2 vaccines and treatments during the urgent times of this pandemic has raised important questions in the general public regarding the safety and efficacy of all medicinal treatments. The need to know what treatments are actually beneficial and which might do more harm than good is more important now than ever.
What is Remdesivir?
According to Health Canada, “Remdesivir (brand name Veklury) is an antiviral drug used to treat patients with severe symptoms of COVID-19, who need extra oxygen to help them breathe.” On Health explains that SARS-CoV-2 is a viral infection that occurs when a harmful virus (in the case of COVID-19, it is a type of coronavirus) enters the body and uses the cell’s organelles (structures) to create more viruses and infect more cells. Viruses rely on their host to be spread. In an active viral infection, viruses attack healthy cells, which weakens the immune system and can deteriorate many organ system functions, according to Harvard Health.
Antiviral drugs are used to combat viral infections by reducing symptoms of infection and often reducing the time a person has the virus. They work by interfering with the process by which a virus jumps from one cell to another. In the case of Remdesivir, according to a study published by the New England Journal of Medicine, the drug inhibits the reproduction of the virus within the cells, just like all other antiviral medications. It is administered via an intravenous (IV) infusion. Many other antiviral drugs are also administered for similar ailments, including influenza.
Currently, in countries like Canada, the drug is authorized for use in healthcare facilities for adults and youth over 12 years of age and 40 kg in weight. It is only being administered to patients with severe symptoms who need supplementary oxygen due to lung infection.
Image is courtesy of Penn Medicine.
How was Remdesivir developed?
Remdesivir was developed by American biopharmaceutical company Gilead Sciences, Inc. The company focuses on researching and developing antiviral drugs used to treat HIV, hepatitis B, hepatitis C, and influenza. They developed it as a nucleotide analog based on the company’s previous antiviral research. Gilead reports that “Veklury [Remdesivir] has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19.”
According to the U.S. National Library of Medicine Clinical Trials webpage, a study by Gilead Sciences was completed from March of 2020 to January of 2021 “to Evaluate the Safety and Antiviral Activity of Remdesivir in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment.” It was a Phase three trial on a total of 1113 participants. The study took place in sites in the United States, Europe, and Asia. The results show that the all-cause mortality rate (mortality during the study for any reason) for patients who received:
Standard of Care (SOC) Treatment: 2.00%
Remdesivir for 5 days: 1.05%
Remdesivir for 10 days: 1.55%
Find the full study results here: https://clinicaltrials.gov/ct2/show/results/NCT04292730
Where is Remdesivir approved?
Reuters states that many countries have now approved Remdesivir as a COVID-19 treatment and authorized it for severely ill/hospitalized patients, including:
Australia
Canada
European Union
Singapore
Taiwan
United Kingdom
United States
The drug has been given emergency use authorization in countries including:
India
Israel
Japan
South Korea
In November of 2020, the World Health Organization released a statement recommending against the use of Remdesivir in COVID-19 patients. They stated that the drug has “no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes.”
The company that created the drug Gilead Science has created a voluntary licensing agreement with the following pharma manufacturers based in Egypt, India, and Pakistan. The companies listed below are allowed to manufacture and distribute Remdesivir in 127 countries, which can be found here: https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir
Cipla Ltd.
Dr. Reddy’s Laboratories Ltd.
Eva Pharma
Ferozsons Laboratories
Hetero Labs Ltd.
Jubilant Lifesciences
Mylan
Syngene, a Biocon company
Zydus Cadila Healthcare Ltd.
Is Remdesivir an effective treatment for COVID-19?
The New England Journal of Medicine trials states that “remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection.” However, despite this study and many others finding positive results, there are some negative points of view. An article in Forbes magazine states that “While clinical trials suggest remdesivir isn’t very effective in treating Covid-19, recent studies have shown that it does block Coronavirus activity.” The article goes on to explain how the media hyped up the preliminary result of the trials. In contrast, the final published data states that “remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.”
To summarize, many studies show that it had some effect on the time taken for patients to recover, but to confirm any results, more testing needs to be done.
Side Effects
While the general consensus is still unclear as to whether Remdesivir is effective or not, it is still being pumped into the veins of thousands of people worldwide every day. Therefore, it is important to understand the potential side effects of this drug.
According to the Mayo Clinic, Remdesivir can cause mild side effects including:
back pain
chest tightness
chills
cough
dark-colored urine
difficulty swallowing
fast heartbeat
fever
flushing
headache
hives, itching
light-colored stools
nausea and vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
stomach pain, continuing
trouble breathing
unusual tiredness or weakness
yellow eyes or skin
Medical News Today adds to that list with two more possible side effects:
rash
high or increased blood sugar level
decreased levels of hemoglobin (a protein in red blood cells)
Many of these side effects listed above are similar to what you would expect after getting a vaccine or having a mild viral infection. However, some are linked to allergic reactions to the ingredients in the drug.
Major side effects, according to Medical News Today, include:
Seizures
Decreased kidney function
Increased prothrombin time (a blood level that measures the risk of blood clotting)
Allergic reaction
Increased levels of liver enzymes, which may be a sign of liver damage
The effects of the drug on your kidneys and liver are due to their roles in filtering out waste and balancing chemical levels in the blood, as Med Page Today explains. Redmisivir is intravenous, meaning it is injected into the bloodstream, so eventually, your kidneys will need to filter it out. The studies have shown that many antiviral medications can harm kidney function and cause liver damage in the long term, so it is advised that people with pre-existing kidney and/or liver issues do not take the drug.
Conclusion
All COVID-19 treating or preventing drugs or vaccines have been researched, developed, and tested in record time, raising the concern that they might not have been tested enough. Trials are still ongoing, but until there is a clear consensus in the medical field about the efficacy of this drug, no strong conclusion can be reached.
Article Author: Ria Patel
Article Editors: Valerie Shirobokov, Victoria Huang