Cloud over efficacy against Omicron but monoclonal antibody therapy still in use

While the second wave of the pandemic saw widespread use of antiviral and immune-modulating drugs, which led to shortages and black marketing, the third wave saw patients being prescribed monoclonal antibody therapy.

Currently, there are two cocktails approved for use. COVID-19 Patients in India – casirivimab and imdevimab are called Regain-CoV2, and Eli Lilly’s bamlanivimab and atacevimab. Both cocktails are indicated for use in people with mild to moderate covid who do not require oxygen, but who are at high risk of developing severe disease.

However, many patients prescribed therapy in the current wave with no significant co-morbidities or high-risk contacts of positive patients were given a “full” dose using the entire pack rather than sharing it with two people Was.

Whereas treatment resulted in a reduction in viral load delta version infections, it has been found to be ineffective against heavily mutated omicron Type. Last Monday, the US Food and Drug Administration revoked the emergency use authorization of both antibody cocktails approved for use in India. A third monoclonal antibody, sotrovimab, which is effective against the new variant, is not approved for use in the country.

Indian Express Spoke to two patients who were prescribed the treatment – ​​one of them chose it while the other did not.

A 38-year-old woman studying in Melbourne, Australia returned to Delhi feeling tired and jet-lagged. A day later when she developed fever and chills, she decided to use a home test kit for COVID-19. They were negative, so she did an RT-PCR test which turned out to be positive. He immediately sent a request for tele-consultation to a doctor from a reputed private hospital in the city.

“The doctor called me 30 minutes after the allotted time from the middle of the traffic and said that I should take antibody cocktail therapy which will cost around Rs 1.5 lakh. I was shocked and told him that I would come back to him later,” said the student. He does not have any co-morbidities.

The prescriptions she received after consultation included therapy with paracetamol, azithromycin and some supplements. She asked some physicians she knew and decided to stick with oral medications only. “I just got better with those drugs. I still feel a little tired, but that’s it.”

She said, “Thankfully I checked in with others, but many people can take therapy without question. My mother was admitted to a hospital in Assam with Covid-19 and she said that some of the ward Other people got it.”

Dr Sumit Ray, medical superintendent and critical-care specialist, Holy Family Hospital, Delhi, said: “What we have seen is that there is demand from patients, who have relatives in Mumbai or Kerala, because it is being used back. . House. There are also some doctors who are taking it forward.”

On the other hand, 37-year-old Karan, a Mumbai resident, thought his high blood pressure and grade III fatty liver disease meant he needed medical attention to stay out of the hospital. He was prescribed a “full dose” of Regen-CoV2 antibody cocktail.

“I came in contact with a colleague who had the infection; I didn’t have any symptoms when I tested positive. By the same evening I had 102 fever and body ache. My doctor suggested that I get the full dose of the antibody cocktail because of my co-morbidity. Thankfully for me the cost, which was over Rs 1 lakh, was not an issue as my company covers the medical treatment,” said Karan, adding that his doctor could not get the monetary incentive as he himself suggested that They should get therapy in another hospital near their home.

“It is a precautionary treatment; I know if I had more symptoms I wouldn’t be able to manage myself. My fever subsided the very night I got the treatment,” he said.

The “full dose” recommended by his doctor means he was given the full 1,200 mg each of casirivimab and imdevimab that comes in a package of Ryzen-CoV2 antibody cocktails.

how it works

Regeneron Pharmaceuticals initially used 1,200 mg doses of each of the two molecules for its clinical trial, but was approved by the United States and India at half the dose, or 600 mg each, when both doses were used. The efficacy was found to be almost identical. The company said on its website that Regen-CoV2 significantly reduced the risk of hospitalization or death by 70% (1,200 mg) and 71% (2,400 mg) compared to placebo.

This therapy uses lab-designed antibody molecules, or a cocktail of such molecules, to bind to the Sars-CoV-2 virus and prevent it from entering human cells.

A recent study published in the journal Nature Medicine, which tested the efficacy of all available monoclonal antibody therapies to neutralize the omicron version of the Sars-CoV-2 virus in petri dishes, found that both the approved in India The treatments have “completely lost the dormant activity. B1.1.529 (Omicron) virus”.

The country’s leading vaccine expert Dr Gagandeep Kang took to Twitter to describe the case of his 90-year-old uncle from Chennai who was given antibody treatment after coming in contact with someone who tested positive for Covid. “We know that 90% or more of infections in Indian cities are currently omicrons. We know that monoclonal antibody products licensed in India do not neutralize Omicron. Yet doctors in private hospitals are prescribing monoclonal antibody therapies. Please remember that even among clinically sensitive people, most contacts will remain asymptomatic or have mild symptoms and recover,” she said.

“It’s immoral, immoral and unscientific,” she said.

However, doctors and medical professionals themselves are using this therapy despite evidence that it does not work against the Omicron variant. At least two doctors from Delhi, who spoke on condition of anonymity, said their colleagues and doctor friends had treated them.

Dr Vinay Aggarwal, President, Pushpanjali Hospital said, “I received treatment. I am over 70 years old, I have chronic bronchitis and a heart condition. I have a history of coughing so hard that I broke my ribs. The government says 80% of cases are omicrons, and the therapy doesn’t work. But very few samples are sequenced and only 8,000-9,000 omicron cases have been confirmed by the government across the country. So why would they say it shouldn’t be used? Our doctors have experience in using the therapy and have found it beneficial. Not everything is misused, doctors should be given the freedom to prescribe treatment once they are approved.”

After testing positive for Covid-19, Delhi-based cardiologist Dr Prem Agarwal also received medical attention. Suspecting the infection, he also fed it to his wife and mother.

“My wife is a cancer Survivor, my mother is over 90 years old, both of whom are at high risk of serious illness. All the drugs tried for COVID-19 work best when given early. So, I decided to administer it to them,” he said.

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Treatment

Lab Developed Antibodies that bind to the virus, making it unable to infect human cells

it will give while the virus is replicating in the body

Treatment Shown to reduce number of deaths, hospital stays and need for mechanical ventilators
therapy should be given to people who have mild to moderate symptoms but are at risk of developing severe disease such as those in the chronic, those with co-morbidities, or immune-compromised

two antibody cocktails Approved for use in India is Regeneron’s casirivimab and imdevimab, and Eli Lilly’s bamalanivimab and atacevimab

got both Sars-CoV-2 . to be ineffective against the Omicron variant of

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