Remdesivir does not reduce COVID-19 linked mortality, the interim findings of a large, international trial sponsored by the World Health Organization (WHO) showed on Thursday, 15 October.

In a news release, the WHO said: “Interim results from the Solidarity Therapeutics Trial, coordinated by the World Health Organization, indicate that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.”

Gilead Sciences, the maker of Remdesivir (trade name Veklury), has, reportedly, put a question mark on these findings, saying that the trial was conducted under a range of circumstances across trial locations. An emailed request for comment had not yet been answered at the time of publishing.

The WHO Solidarity trial studied 11,266 COVID-19 patients across 405 hospitals in 30 countries in a randomized, controlled. To be sure, the trial looked at other repurposed medicines for the treatment of COVID-19, too. These drugs were malaria and lupus medicine hydroxychloroquine, a combination drug lopinavir/ritonavir used in the treatment of HIV/AIDS and remdesivir.

Here’s the breakup of how many patients got remdesivir compared with other treatment:

Drug Patients
Remdesivir 2750
Hydroxychloroquine 954
Lopinavir-ritonavir 1411
Interferons 2063
No study drug, only standard care 4088

Eighty-one per cent or 9,120 patients were 70 years of age, 62% (6,985) were male, 25% (2,768) had diabetes, 8% (916) had been on ventilator. The number of deaths recorded during the period under consideration, from 22 March 2020 till 4 October 2020, was 1,253.

Remdesivir is an antiviral drug. It was originally tested for hepatitis C and Ebola treatment but did not show efficacy against those viral infections. In May 2020, Remdesivir got emergency use authorization (EUA) from the US Food & Drug Administration (FDA) after a trial backed by the US National Institute of Health (NIH) showed that remdesivir reduced hospital stay in COVID-19 patients from 15 days to 11 days on average. On 28 August 2020, the US FDA “broadened the scope” of the EUA, to include the use of Remdesivir in all hospitalised patients.

On 8 October 2020, Gilead Sciences chairman and CEO Daniel O'Day had said in an open letter that "in the largest group of patients in the (NIH-backed) study, those on low-flow oxygen, there was a significant reduction in mortality in a post-hoc analysis". This claim was based on the final results in the NIH-led trials; the study findings were published in The New England Journal of Medicine.

In India, Zydus Cadila, Hetero Labs, Dr Reddy’s Laboratories, Cipla, Jubilant Lifesciences and Mylan are marketing generic versions of Remdesivir at prices starting at Rs2,800 for a 100 mg vial (the drug is administered intravenously; that is, through an IV line).

COVID-19 is a coronavirus infection that has claimed nearly 1.1 million lives worldwide in just over 10 months. In India, 7.3 million people had contracted the illness, 6.3 million patients had recovered and 111,266 patients had succumbed to it as of 16 October 2020, according to data collated by the Johns Hopkins University of Medicine Coronavirus Resource Centre.


Medicines / Products that contain Remdesivir does not reduce 28-day mortality among hospitalised COVID-19 patients: WHO Solidarity Trial interim findings

References

  1. World Health Organization, Geneva [Internet]. Solidarity Therapeutics Trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19 in record time.
  2. World Health Organization International Clinical Trials Registry Platform [Internet]. Solidarity: an international randomized controlled trial to evaluate non-licensed covid-19 treatments in addition to standard of care among hospitalized patients, 16 April 2020 [updated 5 October 2020].
  3. WHO Solidarity Trial Consortium, Hongchao Pan, Richard Peto, Quarraisha Abdool Karim and Marissa Alejandria, et al. Repurposed antiviral drugs for COVID-19; interim WHO SOLIDARITY trial results. medRxiv, 15 October 2020.
  4. US Food & Drug Administration [Internet]. FDA news release: COVID-19 Update: FDA broadens emergency use authorization for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19, 28 August 2020.
  5. O’Day D. An open letter from Daniel O’Day, chairman & CEO, Gilead Sciences, 8 October 2020, Gilead Sciences [Internet], US.
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