Dr Jaideep Gogtay, Global Medical Director, Cipla Ltd explains how it works

Monoclonal antibody therapy, also known as cocktail therapy, has emerged as one of the effective and reliable treatment options for COVID-19. Therapy that aims to reduce viral loads and lessen the severity of symptoms, according to health experts, can also help reduce the risk of hospitalization by 70%. Although the therapy can be extremely effective, but according to global health experts, it is not a substitute for the COVID-19 vaccine. The therapy definitely gives our immune system a much-needed boost and helps the body form antibodies on its own. How does the therapy work? Does it have any side effects? Who is eligible to receive it? Here’s everything you need to know about the new therapy, which is apparently in high demand in India.

1. How is cocktail therapy (monoclonal antibody treatment) different from all other treatments used for the Covid patient?

Casirivimab and imdevimab are the two antibodies that are part of the antibody cocktail. These are proteins that mimic the ability of the immune system to fight off harmful viruses. They are artificially created in a lab and custom made to fight disease. Antibody cocktail therapy blocks virus attachment and subsequent entry into human cells. The use of two antibodies protects against the virus which develops resistance to them. The treatment helps patients infected with the new coronavirus by decreasing the risk of hospitalization by 70%, in high-risk patients, which can ease the burden on healthcare systems.

Other drugs such as steroids and other immunomodulators such as bariticinib and tocilizumab are given to patients with moderate to severe COVID-19 who are hospitalized and require oxygen support and have significant lung inflammation with accompanying increased immune activation. Recently, another antiviral drug, molnupiravir, was approved for restricted use by India’s regulatory agency in patients who do not need supplemental oxygen and are at high risk of developing serious illness.

2. How does monoclonal antibody work in covid patients? How effective is it?

Casirivimab and imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology. Casirivimab and imdevimab are monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2, and designed to block virus attachment and entry into human cells. Two distinct antibodies bind non-competitively to the cell surface of the COVID-19 virus and prevent the virus from infecting healthy cells.

The antibody cocktail is effective in reducing the need for hospitalization by approximately 70% in eligible patients who receive the drug within 10 days of symptom onset. As this drug can be given to patients even with chronic kidney disease, chronic liver disease, immunocompromised people without significant side effects, this drug acts as a good alternative to other Covid treatment modalities in candidates eligible.

3. Which patients should receive monoclonal antibodies?

The antibody cocktail therapy has been approved by India’s regulatory authority, CDSCO, for restricted emergency use in patients with mild to moderate symptoms of COVID-19 in adults, children (12 years and more, weighing at least 40 kg, who are not hospitalized patients and do not require supplemental oxygen) and to patients who are at high risk* of developing severe COVID-19 disease and who do not require oxygen. The drug should be administered within 10 days of the onset of symptoms. Recently, Indian regulations also approved EUA for another indication of post-exposure prophylaxis where it also covers people aged 18 and over who have been/are exposed to someone with the virus or who have been/are exposed to the virus in an institutional setting (e.g. healthcare professionals). In summary, this means that people who are not fully vaccinated or who are vaccinated but are not expected to mount an adequate immune response to fight the virus can benefit from cocktail therapy. Therapy is important for those at high risk of exposure to someone infected with Covid.

High-risk patients are those over the age of 60 with comorbidities such as obesity, type 1 or type 2 diabetes mellitus, or with chronic lung disease, including asthma, or chronic kidney disease, including those on dialysis, or suffering from serious cardiovascular disease. , liver disease, immune deficiencies, HIV (if poorly controlled or a sign of AIDS), sickle cell disease, thalassemia, and prolonged use of drugs that weaken the immune system.

4. What complications or side effects does a patient face after taking the monoclonal antibody?

No serious adverse effects have been reported in clinical trials. Some of the adverse events that may occur are infusion-related side effects such as fever, rash, etc. These were generally mild to moderate in intensity, with severe hypersensitivity reaction such as anaphylaxis being rarely reported in the trials.

5. Has the demand for monoclonal antibodies increased in the event of a pandemic? If yes, then in which wave? First, second or now?

Monoclonal antibody cocktail therapy was launched in May 2021 in India and the demand was high during the 2nd wave. With the recent increase in cases, yes, the demand for the antibody cocktail has increased significantly over the past 10 days.

Limitations to this permitted use include:

1. Post-exposure prophylaxis with Casirivimab and Imdevimab is not a substitute for vaccination against COVID-19.

2. Casirivimab and imdevimab are not authorized for pre-exposure prophylaxis for the prevention of COVID-19.

(The author is a Global Medical Director, Cipla Ltd)

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Posted: Thursday January 13th 2022, 12:26 PM IST