NEW DELHI: Starting July, COVID-19 patients in the country may get access to Ebola drug remdesivir, which has caught attention as a medicine that has shown some promise in reducing the recovery time in a large number of infected patients during a global trial by a premier US health agency.
Four Indian companies — Jubilant Life Sciences, Hetero, Mylan laboratories, and Cipla — have signed a licensing deal with US-based Gilead Sciences that manufactures remdesivir, a broad spectrum anti-viral drug, but the production is yet to start.
“Once the Indian companies start producing remdesivir, its use will be considered (for COVID-19 patients) in India,” Dr RR Gangakhedkar, chief epidemiologist with the Indian Council of Medical Research, told The New Indian Express on Thursday.
The manufacturing of the drug is taking time as it is an intravenous formulation and the bulk supply is set to be ready only by July first week, said officials, adding that the COVID-19 treatment protocol could be amended later to include remdesivir based on the latest evidence.
Dr VK Paul, member (health), Niti Aayog, who heads the national task force on COVID-19 management in the country, said that while remdesivir is not part of the clinical management protocol against COVID-19 in the country yet, “it remains an option.”
So far in India, the drug is being tried only as part of WHO solidarity trial undertaken to assess the efficacy of several repurposed drugs against COVID-19. As it is not available in the market, other patients cannot get it even on compassionate grounds.
The US National Institutes of Health last week said that its data from a trial of remdesivir showed that the drug offers the most benefit for Covid-19 patients who need extra oxygen but do not require mechanical ventilation.
Findings of the study published in the New England Journal of Medicine said that the drug mimics the genetic material of the coronavirus and when the virus copies its RNA or genetic material, the drug replaces some of the pathogen’s building blocks preventing new virus copies from being produced.
Preliminary results have shown that patients who received remdesivir had a 31 per cent faster time to recovery than those who received a placebo.
After the early promising results from the first stage of the Adaptive COVID-19 Treatment Trial (ACTT-1) on critically-ill patients, researchers have now begun the next stage of the trial by combining remdesivir along with a strong anti-inflammatory agent baricitinib.
In this stage of the trial, being called ACTT-2, researchers are looking to assess if baricitinib combined with remdesivir can prevent or reduce the hyper-inflammatory cytokine storm, a leading cause of death in COVID-19 patients.
The drug had also shown promise as a medicine against the Middle East Respiratory Syndrome and severe acute respiratory syndrome, both of which, like COVID-19 are caused by coronaviruses.