Jahnavi Sarma
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Written By: Jahnavi Sarma | Published : October 16, 2020 2:03 PM IST
Remdesivir had earlier received regulatory approvals or temporary authorisations to treat COVID-19 in approximately 50 countries, which also included India.
In the absence of a vaccine for COVID-19, doctors and researchers have tested and sought to repurpose some existing drugs to treat the viral disease. One such drug is Remdesivir, the antiviral drug originally designed to treat Ebola. Some studies say that Remdesivir may decrease the time needed for clinical improvement in moderate to severe cases.
But now, the WHO Solidarity trial has found that Remdesivir, the antiviral drug that's widely prescribed against COVID-19, has no substantial effect on mortality, initiation of ventilation or duration of hospital stay. The results of the Solidarity trial conducted on 11,266 hospitalised patients in 30 countries found that along with Remdesivir, three other repurposed drugs, hydroxychloroquine, lopinavir/ritonavir and interferon, too have little or no effect on 28-day mortality. According to researchers, these remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little effect on in-hospital mortality. WHO discontinued hydroxychloroquine and lopinavir-ritonavir arms in July following the interim results. WHO said the results of the trial are under review for publication in a medical journal and have been uploaded as a preprint at medRxiv - a non peer-reviewed journal.
Remdesivir had earlier received regulatory approvals or temporary authorisations to treat COVID-19 in approximately 50 countries, which also included India. The drug was pre-qualified by WHO. This drug was found to have some benefit in three other randomised, controlled clinical trials. In one large controlled trial in the US, it was seen that the drug shortened recovery time by about a third in severely ill, hospitalised adults with COVID-19, but was of little to help those with milder cases.
However, researchers have expressed concern that the data from the open label global trial have not been under rigorous review. An open label trial means that both the researchers and participants know which drug is being given to participants. The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Remdesivir.
Remdesivir, was originally developed as a treatment for Ebola. The drug was granted emergency use authorisation by the USFDA in May following a trial by the National Institutes of Health, which found that this drug modestly reduced the time to recovery in severely ill patients. Gilead entered into licensing pact with several generic drug makers such as Cipla, Hetero, Dr Reddy's, Zydus Cadila, Jubilant Life Sciences, Syngene and Mylan to manufacture and distribute the drug in 127 countries including India. The drug was found to be a major intervention for moderate to several COVID-19 hospitalised patients. There is also growing demand from doctors to extend the administration of Remdesivir to mild COVID-19 patients.
Initially, the Drug Controller General of India (DCGI) had approved the use of Remdesivir for "restricted emergency use" on severely ill hospitalised coronavirus patients. But then, the government sounded caution on the use of Remdesivir injectable formulation in July. The Indian Council of Medical Research (ICMR) and the All India Institute of Medical Sciences (AIIMS) asked states to use this drug with extreme caution, as their "indiscriminate use or use in conditions for which they are not desirable may cause more harm than good".
(With inputs from Agencies)
