In what could be a first for Delhi, a leading private facility here has received clinical doses for carrying out monoclonal antibody therapy for a certain category of COVID-19 patients that is said to reduce their chance of hospitalisation by 70 per cent, hospital authorities said on Thursday. As part of this single dose infusion-based treatment, patients with mild to moderate symptoms are offered a cocktail of Casirivimab and Imdevimab.
Fortis Escorts Heart Institute (FEHI) in south Delhi, after receiving the doses, has started offering the therapy from Thursday, FEHI chairman Ashok Seth said. “We have received the doses at our hospital. They arrived yesterday and from today, we are all set to offer it to our patients who fit the criteria laid down for it,” he told PTI.
Seth said FEHI has received two doses as of now which can be used for four patients. “Each dose can be used for two patients. However, since the packaging is such that one pack has two vials, and can serve two patients, so after opening the dose and administering it to a patient, the remaining portion has to be administered to another patient within 24 hours,” he said.
Mohabbat Singh, an 84-year-old COVID-19 positive man, was given the monoclonal antibody therapy at Medanta Hospital in Gurgaon on Tuesday and was sent home the same day, after being kept under observation, hospital authorities said on Wednesday, adding that Singh became the first patient to receive the therapy at Medanta. An official of the Gurgaon hospital claimed it was Delhi-NCR’s first case of monoclonal antibody therapy for a COVID-19 patient.
“The antibody combination of Casirivimab and Imdevimab, now available in India, is a cutting-edge treatment that will provide protection to COVID-19 positive patients with mild or moderate symptoms before they deteriorate further or require hospitalisation,” the Medanta Hospital said in a statement earlier. “This FDA approved therapy demonstrated good efficacy in Phase 1/2 and Phase 3 studies by reducing COVID-19 related hospitalisation and death by 70 per cent. Approved by the Drugs Controller General of India (DCGI), this single dose infusion-based treatment can be provided on an outpatient or day care basis and marks a dramatic shift in COVID-19 care in India,” it added.
Seth, a cardiologist, said this therapy is meant for people who are under home isolation, and do not need oxygen support, so the cut-off level of SpO2 is about 93 per cent, and are at high risk due to their co-morbidities such as liver disease, heart ailments or chronic lung disease. “It is not meant for people in ICU or on ventilator or needing any kind of oxygen support. Also, those patients who have anaphylaxis which could entail severe allergic reaction,” he cautioned.
Seth said this therapy approved by the FDA was given to the then US president Donald Trump in 2020, which brought it under the spotlight. Explaining how the therapy works, he said similar to antibodies, which are proteins that the body naturally generates to defend itself against disease, monoclonal antibodies are “artificially created in the lab”.
“So, Casirivimab and Imdevimab used in this cocktail are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, aimed to block the coronavirus‘ attachment and entry into human cells,” Seth said. Two distinct antibodies bind non-competitively to the COVID-19 virus cell surface and prevent the virus from infecting healthy cells. Using two antibodies protects against emergence of resistance, according to Medanta Hospital.
The therapy is most suited for “high-risk COVID-19 patients” who are within first ten days of symptom onset and meet any of the listed criteria, such as age being 65 years or above, it said. Other criteria include obesity with BMI (Body Mass Index) of more than 35; or type 1 or type 2 diabetes mellitus; or chronic kidney disease, including those on dialysis; or chronic liver disease; or currently receiving immunosuppressive treatment; or if aged above 55, having either heart disease or hypertension or chronic lung disease, the hospital said.
Seth said the dosage per person consists of 600 mg of Casirivimab and 600 mg of Imdevimab, adding that the pack contains two vials, and 600 mg each of the two monoclonal antibodies are mixed before administering, “hence the term cocktail is used for it”. Cipla and Switzerland-based Roche launched this antibodies cocktail in the market, he said.
“A company pack contains 1,332 mg each of Casirivimab and Imdevimab. A pack contains two vials, so two patients can be treated. Each vial for a person costs about Rs 59,750,” Seth added.