Updated: October 17, 2020 7:47:18 am
Among the trial treatments, remdesivir is the most sought after. (AP Photo)
The World Health Organization (WHO) released the interim results of the Solidarity Therapeutics Trial, a large-scale global trial studying the effectiveness of various repurposed therapies in treating Covid-19, on Thursday. The results It calmed expectations for these therapies, including remdesivir, which was once seen as promising.
What is the Solidarity Trial?
The WHO and its partners launched the world’s “largest” multinational human trials of Covid-19 therapies in March to help find an effective treatment for Covid-19. Covers four repurposed drugs or drug combinations: remdesivir, hydroxychloroquine, lopinavir / ritonavir, and interferon (in combination with rotinavir and lopinavir).
The study covers more than 400 hospitals in more than 30 countries and looks at the effects of these treatments on various indicators, including their ability to prevent deaths and shorten hospital stays. The trial involved more than 11,300 participants.
The main goal was to help determine whether any of these repurposed therapies could affect hospital mortality at least moderately and whether the effects differed between moderate and severe disease, said Dr Shobha Godbole, national coordinator of the Solidarity Trial in India. The initiative included 26 trials in parts of India with a high caseload. As of October 15, 937 hospitalized Covid patients were participating, Dr. Godbole said.
What have the trials found?
None of the drugs could demonstrate benefits in the parameters studied, especially in reducing mortality among hospitalized patients. Interim results, available from a prepress server, said these drugs had “little or no effect” on hospitalized Covid-19 patients “as indicated by overall mortality, onset of ventilation, and length of stay. hospitable.
Drugs such as hydroxychloroquine and lopinavir, in fact, had already been dropped over the last six months because they were not very promising.
Read also | Why the WHO vs Gilead on remdesivir matters
What are the results of remdesivir?
“The mortality findings contain most of the randomized evidence for Remdesivir and Interferon, and are consistent with the mortality meta-analyzes across all major trials,” the paper stated. The interferon was withdrawn from the trial on Friday.
The findings struck a chord with US biopharmaceutical firm Gilead Sciences, which developed and patented remdesivir. In a statement, it said the emerging data “appears inconsistent” with the “stronger” evidence from other “multiple” studies on the clinical benefits of remdesivir that have been published in peer-reviewed journals. He said that at least three randomized controlled clinical trials have shown the “benefits” of remdesivir.
Other experts have questioned the findings of the trials cited by Gilead Sciences. Dr Srinath Reddy, Chairman of the Public Health Foundation of India and a member of the executive group of the Solidarity Trial steering committee, referred to a trial in more than 1,000 patients in the US “The numbers were relatively small for a clinical trial, and it turned out that the remdesivir group had better prognostic indicators than the control group. So, in a sense, we can’t say that the recovery time was due to remdesivir and not other factors.
“Personal experiences are valuable. However, that does not help to compare in the clinical setting. The solidarity trial has discussed the value of remdesivir in hospitalized patients, ”said Dr Soumya Swaminathan, WHO chief scientist.
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A bottle of hydroxychloroquine tablets in Texas City, Texas. (AP Photo / David J. Phillip, file)
To what extent have these drugs been used in India?
While India stopped using combinations such as lopinavir / ritonavir at the beginning of the pandemic, remdesivir, hydroxychloroquine and interferon combinations are still used as part of the Covid-19 treatment regimen based on the severity of the disease.
Remdesivir, especially, has been highly sought after. India’s remdesivir market size was pegged at around Rs 121.29 crore in the 12 months ending September, according to estimates by pharmaceutical market research firm AIOCD Awacs PharmaTrac. These calculations were based on data available for only four of the various brands of remdesivir: Desrem (Mylan), Remdac (Zydus Cadila), Cipremi (Cipla) and Covifor (Hetero), which means that the market may be even larger.
With several new brands hitting the market, sales have increased. PharmaTrac data shows that sales increased almost 96% between July and September for these four brands.
What impact do these findings have for those who prescribe these drugs?
It is up to several governments, which will answer a call on whether the evidence is compelling enough to remove these therapies from their clinical management protocols. Doctors who feel that medications should be part of treatment can also take a call on how they will be used on a case-by-case basis.
“What the results of the Solidarity Trial tell me is that hydroxychloroquine in toxic doses is more or less in hospitalized patients. As for lopinavir and ritonavir, they are already available. The verdict for interferon has yet to be delivered and we will have to wait for more data, because the body responds to any viral infection by producing interferon, ”said Dr. Shashank Joshi, Dean of the Indian College of Physicians.
The Solidarity Trial involved more than 11,300 participants. (Bloomberg photo: Andrey Rudakov, file)
What about remdesivir?
“While the data on remdesivir is disappointing, we don’t know if it will be his death sentence,” said Dr. Joshi. “Remdesivir will definitely be under pressure to function and its indiscriminate use will stop, but it could still have a place in individualized care.
In any case, there seems to be less enthusiasm for remdesivir than before. “I don’t use remdesivir as much in my patients because when there were shortage issues with the drug previously, I had been prescribing drugs like favipiravir and tocilizumab which also worked very well,” said a doctor from Delhi.
“Now, there seem to be stricter protocols and procedures and a little less anxiety (about how to handle Covid-19) in the last two to three months,” said Dr. Om Srivastava, who practices in Mumbai.
“What the trial has concluded is that there may be no survival benefit from administering remdesivir and that is a conclusion based on these interim data. I think we will still have to wait and see, ”said Dr. Srivastava.
“I think remdesivir works in such a way that if you could give it at the right time, it will cut the total amount of virus that is shed by about two days, sometimes three days. I think it is a huge advantage when you have someone in an ICU who is probably going to a ventilator. So I don’t think remdesivir is redundant, ”he said.
And now what happens with the Covid-19 therapy, waiting for a vaccine?
The findings do not necessarily affect the use of other medications and assisted therapies that have been shown to help reduce deaths and improve clinical outcomes, including oxygen and steroids like dexamethasone, according to experts. Newer therapies, such as antibody cocktails, may also be in focus as part of the Solidarity Trial in the future.
“We are continuing the Solidarity Trial and looking for immunomodulators such as repurposed anticancer drugs and monoclonal antibodies,” said Dr. Swaminathan.
This article first appeared in print on October 17, 2020 under the title ‘The Solidarity Trial Shock Absorber’.
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