Abu Dhabi: An innovative new treatment is revolutionising the fight against COVID-19 in the UAE, with Abu Dhabi being one of the first places in the world offering Sotrovimab to patients.
Last Wednesday, the authorities announced positive results from two weeks of Sotrovimab use. As it gains currency as an effective treatment against COVID-19, here is all you need to know about Sotrovimab:
What is Sotrovimab?
Sotrovimab is a new anti-viral therapy that has been approved for use on patients — aged 12 years or more — with severe attack of COVID-19. It is a monoclonal antibody therapy developed by British pharmaceutical company, GlaxoSmithKline (GSK) and Vir Biotechnology, a clinical immunology therapy developer.
What is a monoclonal antibody and how does it work?
The body’s immune system generates antibodies — specific protein molecules — as a defence mechanism against unfamiliar molecules, called antigens. Molecules from pathogens like bacteria and viruses can act as antigens, prompting the production of antibodies that bind to antigens. This tells specialised cells of the immune system to kill the invading pathogen. Monoclonal antibodies work specifically against a particular portion on an antigen called the epitope, thereby exerting very targeted action.
“For example, the SARS-CoV-2 virus’s spike glycoprotein, which sits on its surface, functions to facilitate the virus’s entry into the body’s cells. So SARS-CoV-2 monoclonal antibodies bind to the spike protein and prevent the virus from entering the cell,” explained Dr Shyam Rajamohan, internal medicine specialist at Prime Hospital.
When was Sotrovimab approved?
The European Medicines Agency approved Sotrovimab for select COVID-19 patients on May 21, 2021. The United States Food and Drug Administration provided emergency use approval (EUA) to Sotrovimab, which it classifies as an ‘investigational monoclonal antibody therapy’, on May 26.
The UAE Ministry of Health and Prevention (MoHAP) went on to approve the therapy days later, on May 29.
Why is Sotrovimab called an investigational therapy?
The therapy received an emergency-use approval or EUA, rather than a Food and Drug Administration approval in the US. This means that the US body that approves medications followed an atypical development and approval process due to the public health emergency created by the COVID-19 pandemic. Under an EUA, in an emergency, the FDA makes a product available to the public, based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
Why is the UAE considered to be ahead in using Sotrovimab for COVID-19 patients?
In less than a month after the treatment was approved, both internationally and in the UAE, Abu Dhabi received the first shipment of the medicine and began offering it to COVID-19 patients.
This was the result of an agreement between Abu Dhabi’s health regulator, the Department of Health (DoH), Abu Dhabi-based procurement firm Rafed, GSK and Etihad Cargo.
How is it administered and where is it available?
Sotrovimab is available as 500mg doses that are administered intravenously.
At present, the treatment is available in Abu Dhabi at public health-care facilities, which are managed by the Abu Dhabi Health Services Company (Seha).
Who is eligible to receive Sotrovimab?
According to its developer, GSK, Sotrovimab can be used to treat mild-to-moderate COVID-19 in adults, and in children aged at least 12 years or weighing at least 40kg, who are at high risk of developing severe COVID-19 symptoms.
Some COVID-19 patients, however, cannot be given the therapy. They are:
— Patients who are already hospitalised due to severe COVID-19.
— Patients who require oxygen therapy due to COVID-19.
— Those who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity).
In the UAE, Sotrovimab has so far been given to people in at-risk groups, announced Abu Dhabi’s health regulator, the Department of Health (DoH). At-risk patients have been defined as people who have comorbidities associated with severe COVID-19, such as obesity, cancer, kidney disease, lung disease, cardiovascular disease, diabetes, hypertension and allergies.
How effective has it been in helping COVID-19 patients beat the illness?
On June 30, DoH released the two-week results of Sotrovimab use in the emirate.
Between June 16 and 29, Sotrovimab was administered to 658 patients with COVID-19. Among the recipients, 46 per cent were Emirati and 54 per cent were expats. About 59 per cent of the recipients were aged 50 years and older.
More than 97.3 per cent of recipients showed improvements within five to seven days and, with symptoms subsiding and nearing full recovery.
What have other analyses of the drug shown?
The FDA has said it has evidence showing that sotrovimab may be effective in treating adults and certain paediatric patients with mild-to-moderate COVID-19.
“When used to treat COVID-19 for the authorised population, the known and potential benefits outweigh the known and potential risks for the drug. There are no adequate, approved and available alternative treatments to Sotrovimab,” FDA said.
In an interim analysis that was double-blinded and placebo-controlled, 583 non-hospitalised adults in the US with mild-to-moderate COVID-19 symptoms were treated with Sotrovimab. The results showed that there was an 85 per cent reduction in hospitalisation and death among patients who received the therapy, compared to those who were given placebos.
“The FDA is carefully monitoring circulating viral variants and their sensitivity to monoclonal antibodies authorised to treat COVID-19, including Sotrovimab. Laboratory testing showed that Sotrovimab retains activity against the current circulating variants first reported in the United Kingdom, South Africa, Brazil, California, New York and India,” it said.
Are any other monoclonal antibodies approved for treatment of COVID-19?
A number of other monoclonal antibody therapies have been approved by the FDA and the European Medicines Agency (EMA) for use on select COVID-19 patients in the United States and Europe:
— Bamlanivimab and etesevimab combined therapy, developed by Eli Lilly and Company.
— Casirivimab and imdevimab combined therapy, known as REGEN-COV and developed by Regeneron Pharmaceuticals.
Former US President Donald Trump famously credited REGEN-COV for his recovery from COVID-19, which he received along with a regimen of other drugs, including zinc, Vitamin D and heartburn treatment.
Are there any side-effects to monoclonal antibody therapy?
Dr Rajamohan said that certain side-effects can occur, including allergic reactions, fever, chills, flu-like symptoms, low blood pressure, increased heart rate, diarrhoea.
Have monoclonal antibodies been used to treat any other diseases?
Monoclonal antibodies have already been in use in the treatment of autoimmune diseases like rheumatoid arthritis, certain cancers and other viral infections.
Are any other drugs approved for COVID-19 treatment? If so, why are monoclonal antibodies considered to be almost game-changing?
A number of drugs have been used so far to treat COVID-19, with degrees of success. For instance, antiviral medication remdesivir — developed to treat Hepatitis C — was approved by the FDA, and used in a wide range of countries to treat COVID-19 patients, including the US and the UAE.
However, therapies REGEN-COV and Sotrovimab have been specifically designed as treatments to prevent the worsening of COVID-19 in an infected patient.
“It has been shown to reduce hospitalisation, mortality and morbidity. Effective treatment of COVID-19 also reduces workload on health-care personnel and facilities. In addition, Sotrovimab can provide immediate protection or treatment to a patient who has been exposed to COVID-19 and is not yet vaccinated, while also helping patients with a reduced or compromised immune response, like older adults. In practise therefore, this can be used as a treatment strategy, along with vaccination, to prevent the progression of the disease,” Dr Rajamohan explained.