Dr. Reddy said that the real-world evidence of this monoclonal antibodies is yet to be established but the clinical studies published in peer-reviewed journals including New England Journal of Medicine are encouraging as they have shown to reduce hospitalization or death by over 70%, including drastic reduction in viral clearance. In this context Dr. Reddy added that the timing and patient selection becomes extremely important.
“Patients over 65, obese patients, with uncontrolled diabetes, cardiovascular patients, those who are under immunosuppressants like cancer patients are ideal candidates for this treatment. The timing also has to be appropriate where it needs to be given within three to seven days at max,” Dr. Reddy, who became the first Indian doctor to get the prestigious Rudolf V. Schindler award, said.
This can be given to patients above 55 years of age if they have heart-related issues like hypertension.
He, further, said that within one week, this treatment can help patients become RT-PCR Negative. “Pregnant women are not supposed to be given this treatment as we don’t have enough safety data for this subset of patients. There is also a possibility to explore the prophylactic usage of this combination especially among the high-exposure groups like healthcare workers. This to be highlighted that as per US FDA, benefits of this antibodies cocktail have not been observed in patients hospitalised due to COVID-19. Moreover, if this combination is administered on patients requiring high-flow oxygen or mechanical ventilation then the clinical outcomes can become worse,” Dr Reddy explained.
“Let us understand a bit about how Monoclonal Antibodies work. They bind to the spike proteins of the virus (S1 and S2) and thereby limiting its replication. Mutation in the virus can impact the effectiveness of this monoclonal antibodies’ treatment. Although the effectiveness against some of the variants have been proven, we are not sure about how it will go against the double mutant B.1.617, the so-called Indian variant. At AIG, we are doing a major study where we are looking at its efficacy against the double mutant variant of the virus,” Dr. Reddy said.
This treatment has the potential to increase mutant variants and that is why irrational use of these antibodies’ cocktails should be absolutely discouraged, he said.
Once administered patients should wait for at least three months before getting vaccinated.
Cost factor of treatment:
One of the most crucial aspect of the therapy is the cost factor, especially in low-middle income countries like India, where the treatment cost is around Rs 70,000. “Hospitals and physicians need to factor in this cost element for its judicial usage,” Dr. Reddy opined.
Also, it worth noting that it is to be given only in hospital setting where there is provision to activate emergency medical system immediately following any infusion related adverse reaction.