While the second wave of the pandemic saw rampant use of antivirals and immune-modulating drugs that led to shortage and black-marketing, the third wave has seen a slew of patients being prescribed monoclonal antibody therapy.
Currently, there are two cocktails approved for use in Covid-19 patients in India — Casirivimab and Imdevimab called Regen-CoV2, and Eli Lilly’s Bamlanivimab and Etesevimab. Both cocktails are indicated for use in those with mild to moderate Covid who do not require oxygen but who are at a high risk of progressing to severe disease.
However, many patients prescribed the therapy in the current wave were those with no significant co-morbidities or high-risk contacts of positive patients, who were given the “full” dose using the entire pack instead of sharing it with two people.
While the treatment resulted in reduction in viral load in delta variant infections, it has been found to be ineffective against the heavily mutated omicron variant. Last Monday, the US Food and Drug Administration revoked the emergency use authorisation of both the antibody cocktails approved for use in India. A third monoclonal antibody, Sotrovimab, which is effective against the new variant, isn’t approved for use in the country.
The Indian Express spoke to two patients who were prescribed the therapy — one of them opted for it while the other did not.
n A 38-year-old woman studying in Melbourne, Australia, returned to Delhi feeling fatigued and jet-lagged. When she got fever and chills a day later, she decided to use the home-testing kits for Covid-19. They were negative, so she got an RT-PCR test that turned out to be positive. She immediately sent in a request for tele-consultation with a doctor from a reputed private hospital in the city.
“The doctor called me 30 minutes after the allotted time, from the middle of traffic, and said I should take the antibody cocktail therapy that would cost around Rs 1.5 lakh. I was shocked and told him that I would get back to him later,” the student said. She has no co-morbidities.
The prescription that she received after the consultation had listed paracetamol, azithromycin, and some supplements along with the therapy. She asked some physicians she knew and decided to stick with just the oral medications. “I got better with just those drugs. I still feel a little tired, but that’s it.”
She added, “Thankfully I checked with others, but many might just take the therapy without questioning. My mother was admitted to a hospital in Assam with Covid-19 and she said some of the others in the ward received it.”
Dr Sumit Ray, medical superintendent and critical-care specialist from Delhi’s Holy Family Hospital, said: “What we have seen is that there is a demand by patients, who have relatives in Mumbai or Kerala, for the therapy because it is being used back home. There are some doctors also who are pushing it.”
n On the other hand, 37-year-old Mumbai resident Karan thought that his hypertension and grade III fatty liver disease meant that he needed the therapy to stay out of hospital. He was prescribed the “full dose” of the Regen-CoV2 antibody cocktail.
“I had come in contact with a colleague who had the infection; I had no symptoms when I tested positive. By the same evening, I got a 102 fever and body ache. My doctor suggested that I get the full dose of the antibody cocktail because of my co-morbidities. Thankfully, for me the cost, which was over Rs 1 lakh, wasn’t an issue as my company covers medical treatment,” Karan said, adding that his doctor couldn’t have had a monetary incentive as she herself suggested he get the therapy at another hospital near his home.
“It is a precautionary treatment; I know I wouldn’t have been able to manage on my own if I had more symptoms. My fever subsided the same night that I got the therapy,” he said.
The “full dose” suggested by his doctor means he was administered the complete 1,200 mg each of Casirivimab and Imdevimab that comes in a single package of the Regen-CoV2 antibody cocktail.
How it works
Regeneron Pharmaceuticals had initially used the 1,200 mg dose each of both molecules for its clinical trial but was approved at half the dose, or 600 mg each, by USA and India when the efficacy of both doses was found to be almost the same. The company, on its website, says that Regen-CoV2 significantly reduced the risk of hospitalisation or death by 70% (1,200 mg) and 71% (2,400 mg) as compared to placebo.
The therapy uses lab-designed antibody molecules or a cocktail of such molecules to bind with the Sars-CoV-2 virus and prevent it from entering human cells.
A study recently published in the journal Nature Medicine that tested the efficacy of all available monoclonal antibody therapies in neutralising the omicron variant of the Sars-CoV-2 virus in the petri dish found that both therapies approved in India have “completely lost neutralising activity against B1.1.529 (omicron) virus”.
The country’s foremost vaccine expert Dr Gagandeep Kang took to Twitter to describe the case of her 90-year-old uncle from Chennai who was given the antibody treatment after coming in contact with someone who had tested positive for Covid. “We know that 90% or greater infections are currently omicron in Indian cities. We know that the licensed monoclonal antibody products in India do not neutralise omicron. Yet doctors in private hospitals are prescribing monoclonal antibody therapy. Please remember that even among clinical vulnerable, most contacts will stay asymptomatic or have mild symptoms & recover,” she said.
“It is unethical, immoral and unscientific,” she said.
However, doctors and medical professionals are themselves using the therapy despite evidence that it does not work against the omicron variant. At least two doctors from Delhi, on condition of anonymity, said their colleagues and doctor friends had taken the therapy.
Dr Vinay Aggarwal, chairman of Pushpanjali hospital, said, “I did receive the therapy. I am over 70 years old, I have chronic bronchitis and heart conditions. I have had a history of coughing so hard that I broke my ribs. The government says that 80% cases are omicron, and the therapy does not work. But very few samples are sequenced and only about 8,000-9,000 omicron cases have been confirmed by the government across the country. So why should they say it should not be used? Our doctors have the experience in using the therapy and have found it to be beneficial. Not everything is misuse, clinicians should be given the freedom to prescribe therapies once they have been approved.”
After testing positive for Covid-19, Delhi-based cardiologist Dr Prem Agarwal also received the therapy. He administered it to his wife and mother as well on suspicion of having the infection.
“My wife is a cancer survivor, my mother is over 90 years old, both are at a high risk of developing severe disease. All of the medicines that have been tried out for Covid-19 work the best when given early on. So, I decided to administer it to them,” he said.
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The therapy
Lab developed antibodies that bind with the virus rendering it unable to infect human cells
It has to be given early on when the virus is replicating in the body
The therapy has been shown to reduce the number of deaths, hospital stay, and the need for mechanical ventilator
The therapy should be given to those with mild to moderate symptoms but are at a risk of developing severe disease such as the old, those with co-morbidities, or the immune-compromised
Two antibody cocktails have been approved for use in India – Regeneron’s Casirivimab and Imdevimab, and Eli Lilly’s Bamlanivimab and Etesevimab
Both have been found to be ineffective against omicron variant of Sars-CoV-2
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