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The latest findings from the World Health Organisation’s (WHO) Solidarity Trials may complicate India’s COVID-19 treatment plan.
On 15 October, the WHO released the results from their Solidarity Therapeutics Trial and found that Gilead Sciences Inc’s Remdesivir had either no or very little effect on a COVID-19 patient’s chances of survival or length of hospital stay.
Dr SP Kalantri, Medical Superintendent of Kasturba Hospital and MGIMS, Wardha, Maharashtra, tweeted about the same,
What does this mean for India, where Remdesivir is part of the Health Ministry’s protocol for COVID-19 treatment?
FIT speaks to intensivist Dr Sumit Ray, a senior consultant of Critical Care Medicine at the Holy Family Hospital in Delhi, who runs a COVID ward, to find out more.
But first, let’s get back to the basics. What is Remdesivir and how was it supposed to help?
Remdesivir is an antiviral drug developed by American pharmaceutical giant Gilead Sciences. It was made to treat hepatitis C and respiratory syncytial viruses over a decade ago, but it never got marketing approval.
Antivirals are drugs used for treating viral infections.
Gilead too did not claim it worked, but it became thrust into the limelight as a potentially promising drug. Soon in April, the New England Journal of Medicine published a study where out of 61 patients who were hospitalised with COVID-19, 53 were given the drug and 68 percent improved while 13 percent died.
However, they were not able to say this was due to the drug as there was no control group. It is important to note that Gilead employees co-authored the paper. “This presents a huge conflict of interest,” says Dr Ray.
He adds that you will not need this for “90 percent of patients.” Hypothetically, if you could detect that someone has the viral infection without symptoms, that is the best time for the antiviral to be given for it to work. “Once the virus starts replicating there is not much the antiviral can do,” adds Dr Ray.
This is no mean feat – how can we determine who has the virus before symptoms persist? “This has always been the chicken and egg question with antivirals for respiratory illnesses.”
This happens in general with all antivirals, but focusing on Remdesivir and COVID-19, Dr Ray says that we need to examine the results from Solidarity Trial and the Adaptive COVID-19 Treatment Trial (ACCT1), which was a large trial in the UK and Europe. Now, the ACCT1 trial showed a reduction in the length of hospital stay but it is important to analyse the sub-groups of patients from the large trial.
So, the timing of administering the drug and the severity of the infection are crucial determinants.
Therefore, from the sub-group analysis from the ACCT1 trial, it’s clear that if at all anyone benefited, it was those patients on low oxygen. Dr Ray added that among the sub-group, racially and geographically, it was only beneficial to white people from North America – not in Europeans, Asians or Black people. “So its role is questionable,” adds Dr Ray.
However, in the Solidarity Trial, no one benefited from any sub-group.
“Like in most respiratory diseases, most antivirals do not seem to have any benefit. Usually, the focus on those patients who have a severe disease is ICU care, oxygen etc,” says Dr Ray.
So COVID-19 has 2 phases:
“The role of steroids is usually when our immune response is causing a problem, and here those on oxygen and ventilators benefit the most,” says Dr Ray. “Because steroids are so successful, everyone is prescribing steroids the day COVID-19 is detected and that is actually causing a big problem. It is prolonging the viremia and suppressing the immune response when at that phase, it is necessary. The immune response is a necessary evil, and we need a balanced one for COVID-19 – one that attacks the virus well but not our body. ”
Now, if steroids are needed, doctors were administering Remdesivir. “But with this trial, the role of Remdesivir becomes questionable.”
So doctors are using it in the early subset of patients with low oxygen requirements. “We are using it much more aggressively early in the phase, and once the patient is on the ventilator or more serious, then the possibility of using Remdesivir is more questionable. Though we did use it, as it was recommended and we thought there was space for it.”
Dr Ray adds that they faced similar issues with convalescent plasma. Finally, the ICMR study found it to be ineffective.
While doctors are the ultimate decision-makers in treating COVID, the patient also does have a say.
What happens when a drug like Remdesivir (or convalescent plasma) is highly publicised despite ineffective clinical results? Especially given the fact that COVID-19 is a virus that has taken over the world and patients are doubly worried. “So imagine if a patient is sick, and we don’t give them Remdesivir despite it being part of the government guidelines, and the patient dies. Then the family will blame us for not giving the drug,” ponders Dr Ray.
For plasma, there was not enough evidence, so it was still easier to convince patients to wait for more information. “We fought hard against it, we gave it only to four out of 300 patients, and only because they really demanded it and we were under pressure.”
The guideline needs to be worded very precisely, says Dr Ray, where there is freedom given to doctors in critical care to give the drug to specific patients who are in specific sub-sets.
So, for now, the ministry has said they are examining the data from the Solidarity Trials and taking another look at the current guidelines.
(The article was first published in FIT and has been republished with permission.)
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