While doctors said that it has not affected mortality rates related to Covid-19, the drug has shown reduction in time to clinical improvement. (Gilead Sciences via AP)
There has been a revision in the treatment protocol for clinical management of Covid- 19 patients, Indian Council of Medical Research (ICMR) Director General Dr Balram Bhargava said on Wednesday. “We will put up details on the website on Thursday,” Dr Bhargava told The Indian Express.
According to sources, the apex health research body, ICMR, has been considering the use of Remdesivir, an antiviral drug which has shown improvement in Covid-19 patients in formal clinical trials. Currently, Remdesivir is allowed for emergency/compassionate use in treating severely-ill Covid-19 patients and it is likely to be part of the revised protocol.
Remdesivir was granted emergency use authorisation by the US Food and Drug Administration last month and has received approval by Japanese health regulators. According to sources,with the government set to procure the drug, Indian companies are looking at manufacturing biosimilars. “So far, hospitals do not have the drug,” said intensivists at various dedicated Covid hospitals.
According to reports, US-based Gilead Sciences has given a voluntary licence for production of Remdesivir to four companies in the country. Research on the efficacy of Remdesivir in the treatment of Covid-19 is part of WHO’s Solidarity Trial.
Recently, researchers also reported in the journal Nature that treatment with the antiviral drug Remdesivir has been found to reduce viral load and prevent lung disease in macaques infected with SARS-CoV-2. The study supported the early use of Remdesivir treatment in patients with Covid-19 to prevent progression to pneumonia.
While doctors said that it has not affected mortality rates related to Covid-19, the drug has shown reduction in time to clinical improvement.
But the drug is expensive and questions are bound to arise on the availability, sources said.
Dr D B Kadam, chairman of a special task force of specialist doctors for Pune that had recommended Tocilizumab for Covid-19 patients in case their condition worsens, said that till date, no single therapy was cent per cent effective and there was a need to use multiple options.
“Various repurposed drugs are in preliminary trials and we need to explore antiviral agents one by one. If the drugs are available, we can use them… importantly, patients need to come in early for treatment,” Dr Kadam told The Indian Express.
According to Dr Parikshit Prayag, consultant at Deenanath Mangeshkar Hospital, which has treated approximately 500 Covid-19 patients, of whom 364 were discharged – it was crucial to identify the underlying mechanism of why oxygen levels were dropping among patients. “So, if the patient worsens, some questions need to be addressed such as whether the virus is promoting clotting of arteries in the patient, if he/she has cardiac dysfunction, or whether there is a direct effect on the lungs (where drugs like HCQS and Remdesivir would come into play). The fourth question would be whether a hyper immune response is damaging the lungs and lastly it would be to check the patient for secondary bacterial infections,” Dr Prayag said, stressing that careful clinical management was crucial.
In a recent study in the New England Journal of Medicine, preliminary findings supported the use of Remdesivir for patients who are hospitalised with Covid-19 and require supplemental oxygen therapy. However, given the high mortality despite the use of Remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient and future strategies should evaluate anti-viral agents in combination with other therapeutic approaches to improve patient outcomes in Covid-19, the NEJM study said.