The rampant use of monoclonal antibodies on Covid patients has prompted the state to frame a protocol on use of the cocktail drug that costs Rs 60,000 to Rs 70,000 per dose.
According to the draft guidelines, any doctor or hospital willing to prescribe it must first rule out it’s an Omicron case using an S gene target failure test or through genome sequencing. Roche’s antibody cocktail (containing casirivimab and imdevimab), which is marketed by Cipla in India, does not retain neutralising activity against Omicron by the manufacturer’s own admission.
Despite Roche’s statement, it is being prescribed and pushed indiscriminately by all quarters to make profits, a senior state official told TOI. “Hospitals have laid out OPD beds just to administer this drug, but since it is expensive, many are getting hospitalised for a day so that their medical insurance covers it,” added the official.
Worryingly, the antibody cocktail isn’t the only drug being misused in Covid treatment in the state. National Covid task force members said they are concerned about Molnupiravir, an anti-viral drug aimed at Covid, and azithromycin being widely prescribed.
The proposed protocol on monoclonal antibodies has said Covid patients above 12, who are at high risk of progressing to severe disease, can receive the drug irrespective of vaccination status when they are showing mild to moderate symptoms and not requiring oxygen. The elderly, the obese, people with chronic kidney disease, heart diseases, immuno-suppressive disorders, among others, have been listed as some of the categories with the risk of developing severe Covid. Individuals who are not expected to mount an adequate immune response to vaccination can also be candidates.
Several doctors said ruling out Omicron before initiating treatment is not practical as the S gene target failure test is not available in every hospital and genome sequencing reports take between 5-7 days. The state official retorted that any hospital administering monoclonal antibodies can invest in S gene target failure kits that can give results in three hours.
Dr Vasant Nagvekar, an infectious disease consultant and member of the Covid task force, said the antibody cocktail was certainly not for every patient. But differentiating between Delta and Omicron based on clinical symptoms alone is difficult. “Some markers that we go by are CT scan abnormalities, prolonged fever that comes and goes, longer incubation period-all these can be tentative signs of infection by Delta,” he said. Nagvekar added that ICUs are seeing more admission and it is important not to miss Delta under the cover of Omicron.
Experts are also worried about the oral drugs being prescribed. “Molnupiravir is not recommended for management of mild illness… In the only Molnupiravir study, a modest benefit was seen only among unvaccinated patients with obesity,” said infectious diseases expert Sanjay Pujari, member of the national task force. “Similarly, antibacterials, including azithromycin, are also being unduly prescribed to mild Covid patients,” he said.
Dr Chandrashekhar T, director (critical care), Fortis Hiranandani, Vashi said many mild cases are purely viral and can be treated symptomatically. “Molnupiravir and azithromycin have not been included in WHO (or) ICMR guidelines. The Union health ministry has also raised the red flag as Molnupiravir is not free from adverse effects. It’s also not indicated in pregnant women due to the chances of foetal defects,” Chandrashekhar said.
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