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Solidarity Trial

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October 17, 2020

Why in news?

The World Health Organization (WHO) made available interim results from the Solidarity Therapeutics Trial.

What is the Solidarity Trial?

  • Initiated by WHO and its partners, the Solidarity Trial is the world’s largest multinational human trials on Covid-19 therapeutics.
  • The trial covers four repurposed drugs or drug combinations.
  • This includes remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon (in combination with rotinavir and lopinavir).

What is the aim?

  • The study spans over more than 30 countries involving 11,300 participants in the trial.
  • It included 26 trials in parts of India with a high burden of cases.
  • The study looks into the effects of these treatments on various indicators, including their ability to prevent deaths and shorten hospital stays.
  • The aim was to help determine whether any of these drugs could at least moderately affect in-hospital mortality, and whether any effects differed between moderate and severe disease.

What have the trials found?

  • None of the drugs was able to prove benefits across the parameters studied, especially in reducing mortality among hospitalised patients.
  • The interim results said these drugs had little or no effect on hospitalised Covid-19 patients as indicated by overall mortality, initiation of ventilation and duration of hospital stay.
  • Drugs like hyrdoxychloroquine and lopinavir had already been dropped over the course of the last six months for not showing much promise.

What are the other findings?

  • The mortality findings contain most of the randomized evidence on Remdesivir and Interferon.
  • The findings are consistent with meta-analyses of mortality in all major trials.
  • Interferon was also dropped from the trial.
  • The findings struck a nerve with American biopharmaceutical firm Gilead Sciences, which developed and patented remdesivir.

To what extent have these drugs been used in India?

  • India stopped use of combinations like lopinavir/ritonavir early into the pandemic.
  • But, remdesivir, hydroxychloroquine and interferon combinations are still used as part of the Covid-19 treatment regimen.
  • Remdesivir, especially, has been heavily sought after.
  • The size of India’s remdesivir market was pegged at around Rs 121.29 crore in the 12 months ended September.
  • These calculations were based on data available for only four of the several remdesivir brands. This means the market may be even larger.

How much of a blow are these findings to those prescribing these drugs?

  • The governments will take a call on whether the evidence is convincing enough to remove these therapies from their clinical management protocols.
  • Doctors who feel the drugs should be part of treatment may also take a call on how they will be used on a case-by-case basis.

What about remdesivir?

  • The data on remdesivir is disappointing, and it will be under pressure to perform.
  • Remdesivir’s indiscriminate use will stop, but it still might have a place in individualised care.

What now for Covid-19 therapeutics, pending a vaccine?

  • The findings don’t impact the use of other drugs and assisted therapies that have been proven to improve clinical outcomes.
  • Newer therapies like antibody cocktails may also be in focus as part of the Solidarity Trial going forward.
  • The WHO will continue with the Solidarity Trial and look at immuno modulators.

 

Source: The Indian Express

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