The Truth About Molnupiravir COVID-19 Pill: 'Risks Too High', Say Some Experts
Molnupiravir COVID-19 antiviral drug: Here's what experts have to say about its use, side effects, risk.
With COVID-19 cases and even hospitalisations going up in the country, all eyes are on the next line of defence after the vaccines—COVID-19 treatments.
The latest antiviral pill to join India's COVID arsenal, Molnupiravir, has been making waves off late, with many experts questioning its risk-to-benefit ratio.
How much do we know about the ambitious pill named after Thor's hammer, Mjölnir?
Does it work against Omicron?
FIT speaks to Dr SP Kalantri, Director professor of Medicine at MGIMS and Medical Superintendent of Kasturba Hospital, Mumbai, and Dr Rahul Pandit, Director, Critical Care, Fortis Hospital, Mumbai, and Member of Maharashtra's COVID-19 Task Force.
Molnupiravir: What We Know
Molnipuravir, produced by US based pharma, Merck Sharpe Dohme (MSD) and Ridgeback’s was approved for use in India by the Drugs Standard Control Organisation on 28 December.
It is an experimental antiviral treatment that works by introducing errors into the genetic code of the virus, preventing it from mutating. This further keeps the illness from getting worse.
According to the company, Molnupiravir, is to be used in COVID patients who have,
Mild to moderate illness
At least one comorbidity
Not been hospitalised
Are over the age of 18
The pill is also meant to be taken 5 days after the onset of symptoms.
Final phase 3 clinical trial results of the drug found that Molnupiravir was 30 percent effective in preventing hospitalisations and death in the subset of patients it was tested in.
Although 30 percent reduction in hospitalisation death may seem impressive, Dr Kalantri Director professor of Medicine at MGIMS and Medical Superintendent of Kasturba Hospital says, a closer look shows a slightly different picture.
"If you look at the absolute risk reduction, it was very small—only 3 percent," he says.
'For a Very Specific Subset of Patients'
The double blind randomised clinical trials involved 1433 participants. It was conducted on a very specific subset of non-hospitalised, unvaccinated COVID patients with mild to moderate illness.
"If you identify such individuals who fit the exact criteria of the study participants, even then out of 33 individuals, only one individual will not go to the hospitals," says Dr Kalantri.
"You could say that the one person going to the hospital could be a matter of chance and not statistically significant," he adds.
"Another thing that we need to consider is that 16 percent of the participants of this trial had diabetes. So one in six chance that the person would have diabetes, and this drug didn't work on people with diabetes."Dr SP Kalantri, Medical Superintendent of Kasturba Hospital, Mumbai
Another important factor that limits the effectiveness of the drug in our country where the incidence of diabetes after the age of 40 is pretty high.
The drug is also not recommended for pregnant women, lactating women, and children below the age of 18 because of the high risk of side effects associated with these groups.
Does Molnupiravir Work Against Omicron?
Earlier this week, Dean Li, president of Merck Research Laboratories, declared that the company is confident of the pill's ability to fight Omicron and any other variant.
Speaking to FIT, Dr Rahul Pandit, Director, Critical Care, Fortis Hospital, Mumbai, and Member of Maharashtra's COVID-19 Task Force also says, "it probably works against Omicron as well. I believe it would work against all the COVID variants we know as of now."
"The fact that it has the RDPB inhibition mechanism means that it will definitely have some amount of effect against Omicron."Dr Rahul Pandit, Director-Critical Care Fortis Hospitals Mumbai
The problem, however, is that it hasn't been clinically tested against Omicron.
The Omicron variant wasn't present when the clinical trials were conducted. Most patients then, were infected with Delta. Since then, no other trials have been conducted either.
So essentially there isn't any conclusive clinical evidence to suggest it does work against Omicron.
"Lack of evidence doesn't mean there won't be any evidence at all. You need to generate evidence. Instead of ambiguously saying it wouldn't work against Omicron, I would say, collect data against Omicron."Dr Rahul Pandit, Member of Maharashtra's COVID-19 Task Force
Is it Worth the Risk?
"I am a bit concerned about this drug because although the results look positive, we don't know what would happen in the long run," says Dr Kalantri.
"We had had many drugs in the past that seem promising at first, but when they were followed for five to seven years, they show their true colours."Dr SP Kalantri, Medical Superintendent of Kasturba Hospital, Mumbai
He gives the example of Vioxx, a painkiller that set off 'an epidemic of heart attacks, and Thalidomide that led to multiple miscarriages and deformities in babies.
Another concern he points out is the risk it poses to women in the reproductive age, as well as the sperm quality of men.
On 11 January, Dr NK Arora, Chairman of COVID-19 Working Group of NTAGI told ANI that the use of the pill should be restricted to the elderly, and particularly avoided in people of the reproductive age.
Sexually active male participants of the clinical trial, too, were asked to use contraceptive for at least 3 months after the trial period.
"I find this absolutely impractical in our country," says Dr Kalantri.
Explaining why it was done, he goes on to explain, "the drug works on rapidly dividing cells, and sperm itself is a very fast dividing cell. So, it is possible that the drug itself would act on the cells and increase the risk of foetal abnormalities later on, because the sperm itself is defective now."
"In a country like ours, it would be really difficult to make sure that men and women of reproductive ages use contraception for 3 months after the treatment."Dr SP Kalantri, Medical Superintendent of Kasturba Hospital, Mumbai
"We don't know what the long term risk is here. The benefits are very small, they are not statistically significant, and potential risks are large," he concluded.
Speaking of whom the drug would be suitable for, Dr Pandit says, "the indication here is somebody who is having symptoms, is over 60 years of age, has one or more comorbidities, and who's symptoms are not subsiding for over 48 hours. That's the patient I would choose to give (Molnipiravir)."
"In any other patient, I think it is difficult to justify the use of Molnipiravir now."Dr Rahul Pandit, Director-Critical Care Fortis Hospitals Mumbai
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