The monoclonal antibody cocktail, REGN-COV2, has proven to be a life-saving treatment for some of the most severely affected individuals. COVID-19 Patients, results of clinical trials in the UK are shown. How important are the findings to managing Covid-19, including India?
What is a monoclonal antibody?
To fight viral infections, our body makes proteins known as antibodies. Monoclonal antibodies are artificial antibodies that mimic the activity of the immune system. They are produced through a process that involves extracting specific antibodies from human blood and cloning them.
These monoclonal antibodies are designed to target the virus or specific parts of it. For example, REGEN-COV2 is a cocktail of two monoclonal antibodies developed to target the SARS-CoV-2 peplomer. Monoclonal antibodies bind to specific parts of peplomer proteins and block their ability to infect healthy cells.
In addition to Covid-19, monoclonal antibodies are used to treat Ebola and HIV as well as cancer.
How important are they in Covid-19 treatment?
Study inside Pandemic There is growing optimism about the ability of monoclonal antibodies to help reduce the risk of hospitalization. At the White House briefing on June 3, some monoclonal antibodies showed the ability to retain activity against multiple variants of the virus, said the US President and Chief Medical Advisor of the National Institute of Allergy and Infectious Diseases. Dr. Anthony Fauci suggested. ..
Although an important and promising part of treatment, monoclonal antibodies also have limitations. So far, these treatments have been the most successful in the mild to moderate Covid-19 high-risk group. Not approved for use by people who are hospitalized with severe Covid-19 or who require oxygen.
According to Dr. DBehera, a former HoD of PGIMER at the Padmashri Church, it is very important to provide “the right patient at the right time” to maximize profits, especially in resource-constrained environments. ChandigarhRespiratory department.
According to Dr. VK Paul, a member of NITI Aayog and chair of the National Expert Group on Vaccine Management for Covid, some new variants, such as DeltaPlus’s “Vaccine of Interest,” also disable the use of monoclonal antibodies. Shows the ability to. 19.
What does the new study show?
Oxford University said in its recovery trial last week that Regeneron’s monoclonal antibody cocktail reduced the risk of death by a factor of five in critically ill Covid-19 inpatients who “have not started their own natural antibody response.” I said I got it. Those who have received standard care. “Therefore, for every 100 such patients treated with the antibody combination, there will be 6 fewer deaths,” the university said in a statement.
This treatment reduced the length of hospital stay for patients who lacked their natural antibody response by four days. It also reduces the risk of needing a ventilator. However, “no such benefit was seen across the study population,” including patients who were able to initiate a natural antibody response.
These findings basically mean that treatment is most beneficial to people who, even if they develop severe symptoms or are hospitalized, are unable to develop their own antibody response.
Between September 2020 and May 2021, there were 9,785 participants, which “decisively” determine whether this treatment will reduce the mortality of inpatients with severe Covid-19. This is the first test of sufficient scale. This is important given that this treatment has so far been approved only for mild to moderate Covid patients.
Is this treatment available in India?
REGEN-COV2 is marketed in India in partnership with the leading Swiss pharmaceutical company Roche and the Indian company Cipla. This treatment, which is a combination of the monoclonal antibody casilibimab and imdebimab, received a restricted emergency use authorization from the Central Drugs Standard Control Organization in May.
At the beginning of June, another antibody cocktail therapy, Eli Lilly’s gamlanivimab and etesebimab, received similar urgent approval.
Both antibody cocktails have been shown to be used in patients with mild to moderate Covid-19 who do not require oxygen and are at high risk of developing severe disease.
GlaxoSmithKline, which announced the US FDA’s emergency approval for sotribimab on May 26, is looking for options to make monoclonal antibody therapy available in India.
In India, Zydus Cadila will take the antibody cocktail ZRC-3308 throughout the study.
is it expensive?
Such treatments are difficult, time consuming and costly to make. In India, Cipla supplies 100,000 packs of REGEN-COV2 at a maximum retail price of around Rs 1.20 per pack. If one pack provides treatment to two patients, the price of a single dose for one patient is Rs 59,750 including all taxes.
Eli Lilly has “active dialogue” with the Government of India to “donate” antibody cocktails to Covid-19 patients.
Monoclonal antibodies need to be produced in tissue culture, said Dr. Arturo Casadevall, chair of the Department of Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health. “The cells need to grow, and these cells need to produce protein and purify it,” Dr. Casadevall said in a school “Public Healthon Call” podcast on November 2nd. It was.
How are monoclonal antibodies compared to convalescent plasma therapy?
India stopped using convalescent plasma as an “off label” option last month due to guidance on Covid-19 treatment. For the past eight months, evidence from trials has shown no significant benefit in improving patient outcomes.
Compared to plasma, scientists are confident in the potential of monoclonal antibodies. Both antibody-based therapies differ in how they are made.
Convalescent plasma therapy involves providing antibodies from the collected plasma of Covid-19 patients. This means that the person receiving this treatment has all the antibodies produced by the recovered patient.
Monoclonal antibodies are the mass production of specific antibodies in a factory. For antibody cocktails, we offer a combination of two or more such antibodies.
Monoclonal antibodies are “very pure” because of their homogeneity, Dr. Forch told MedPage Today in August. “The difference between monoclonal antibodies and convalescent plasma is that plasma contains many other things that can cause allergic and other reactions,” Fauci said. Data from clinical trials of monoclonal antibodies at the time showed that they were “a very promising form of prevention and treatment,” Dr. Fauci said.
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