NEW DELHI: A month after an antibody cocktail was approved for treating mild to moderate Covid-19 in high-risk patients in India, some leading private hospitals in the country have said that they have achieved remarkable results with its usage so far.
This therapy, due to its exorbitant cost and very complex manufacturing process, however, is likely to remain a niche product and not a widely used tool in the country's fight against the pandemic.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off viruses. Of late, some monoclonal antibodies have been specifically designed to target the spike protein of the Covid virus -- they do not let the virus attach itself and enter into the human cells.
In early February this year, the US drug regulator issued an emergency use authorization for monoclonal antibodies -- bamlanivimab and etesevimab -- months after the then US president Donald Trump was treated with the therapy while being infected with the Covid virus.
The antibody cocktail needs to be used only for patients with mild to moderate Covid-19 who are at high risk for progressing to severe Covid-19, such as those with diabetes, heart disease, stroke, hypertension, chronic kidney, liver or lung problems and cancers or those above 65 years.
The therapy, though, cannot be used in patients who develop hypoxia or are in need of hospitalization.
In the US, the approval was granted after a clinical trial showed substantial benefits to those who had received the therapy.
In a randomized, double-blind, placebo-controlled clinical trial in 1,035 non-hospitalized adults who fulfilled the trial inclusion criteria, 518 received a single infusion of monoclonal antibody and 517 received placebo. The findings showed that this treatment prevented case escalation from mild to moderate illness to the severe stage, which requires hospitalization, by up to 70 %.
In India too, the combination of Casirivimab and Imdevimab by Roche India and Cipla, which can be given only to high-risk patients within 10 days of the disease's onset, was made available in May end following approval from the Central Drugs Standard Control Organization.
The drug, indicated for use in all high-risk patients above 12 years comes in a two-dose pack with one patient needing just one dose and costs nearly Rs 60,000 per patient and can be given in only outpatient settings.
Akanksha Chawala, a critical care pulmonologist at Apollo hospital in Delhi, said she had used the therapy in just two patients but the results had been extraordinary.
"There is not just hype but actual benefit after this therapy," she said, adding that the cost of the treatment and its availability in a two-dose pack is a big detrimental factor when it comes to its wider use.
"In the absence of any reliable antiviral therapies for Covid-19, antibody cocktails can be a viable option for many but I am not sure how many people will ultimately get to use this," she said.
Anupam Singh, an infectious disease expert in Ghaziabad, pointed out that due to the high costs and complex manufacturing process only a certain class of people may ultimately benefit from the treatment.
SP Kalantri, senior clinician and a medical researcher at Mahatma Gandhi Institute of Medical Sciences in Wardha, meanwhile, pointed out a larger equity issue related to the treatment.
"If physicians decide to treat Covid patients with the antibody cocktail, they will not only be treating only rich people who have resources and access to the hospital but they will also be undermining the common good if applied indiscriminately: this approach might divert resources and supporting infrastructure required for administration of the expensive medicine from the poor patients," he said.
Thus, the public hospitals -- primary health centers, community hospitals, district hospitals and medical colleges -- would not be able to administer it to large populations who qualify for the antibody but have no money, Kalantri added
"The policy makers and health professionals must ensure equitable access to these treatments -- an impossible task given our population, economics, and health infrastructure," he said.