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.

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.

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 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.

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 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.

"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.

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.

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."

"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)."