This undated image provided by Merck & Co. shows their new antiviral medication. Pharmaceutical company Merck & Co. announced on Oct. 1, 2021, that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.
'This could be a big deal': Dr. Gupta on Covid-19 pill study
02:24 - Source: CNN

Editor’s Note: Kent Sepkowitz is a physician and infection control expert at Memorial Sloan Kettering Cancer Center in New York. The views expressed in this commentary are his own. View more opinion on CNN.

CNN  — 

A new approach to managing the Covid-19 pandemic now could be on the table: antiviral pills. On Friday, Merck and Ridgeback Biotherapeutics said their results (still not peer-reviewed) demonstrate their novel drug molnupiravir cut in half the rate of hospitalization and death in persons with mild to moderate disease. If authorized by the US Food and Drug Administration for emergency use, the pill would become the first oral medicine to fight viral infection for Covid-19.

Kent Sepkowitz

If the results hold up to scientific scrutiny, this is very big news indeed. Effective pills given to outpatients could make a large difference for several distinct groups: for people with mild illness, it could prevent progression to more severe, even life-threatening illness, as the study apparently shows; provide an alternative approach to prevent severe disease in vaccine-refuseniks and vaccine-non-responders (those with severely weakened immune systems); and potentially protect those with recent close exposure to an active case (studies already are underway to examine this last possible use).

We have limited study information so far, so caution is advised. However, the most promising “tell” is the decision of the Data Safety and Monitoring Board (DSMB), a group of outside experts not involved in the trial, who review updated data regularly with no idea which people are receiving the drug and which are receiving placebo. They just look at extracted raw numbers. And they saw a strong enough difference to stop the trial before completion: only 775 people were randomized, less than half of the 1,850 planned participants.

Thankfully, the group with the better outcome turned out to be those on molnupiravir, not placebo. Of those 775 participants, all had at least one co-morbid condition placing them at higher risk for progression to severe disease; 385 received the active drug and saw their rate of hospitalization or death reduce from the 14.1% seen in the placebo group to 7.3%, according to the study. Furthermore, the company reported that the new drug had fewer reported side effects than placebo.

All good for sure. But more information is needed: for example, The Washington Post reported that the trial only included the unvaccinated. This makes some sense in that the study commenced in October of last year, well before vaccines became available and was intended to be conducted in 173 locations, including some where vaccine rollout was delayed well past than seen in the United States.

But it also means that the benefit in those with normal immune systems who develop a vaccine-breakthrough infection is uncertain. We also don’t have information yet on teens and younger children, a population that could possibly benefit greatly, given the lack of authorized vaccines for 11-year-old and younger kids and low-ish vaccination rates in US teens.

Of course, we don’t have all of the answers from one smallish clinical trial. But before we declare this yet another game-changer or the Holy Grail, it is important to pause and consider the direction things may be going.

With the molnupiravir news, other antivirals in the mature pipeline and less mature pipeline likely will become the new hot thing, a darling of investors and other professional optimists.

That is also great. Pills could add even more oomph to the pandemic control efforts already begun by our remarkable vaccines. But let’s all remember one additional fact: as much as some people don’t like vaccines, many really don’t like pills that much either. And when the pill is given twice a day – even in short courses as proposed for molnupiravir (twice daily for five days) – adherence is lower than that for a once-daily pill.

Plus, there are all the other problems with pills: cost, side effects, drug resistance, use in pregnancy and, most of all, practicality. Antiviral agents work best when given at first symptoms of disease. Symptoms of early Covid-19 resemble those of countless other viral respiratory infections, such as flu and common colds: sniffles, cough, an upset stomach, a little fever. Nothing specific. A rapid cheap diagnostic test could clarify the decision, but adds time, cost and a different set of uncertainties regarding test accuracy.

Yet the biggest problem with hoping for too much out of oral Covid-19 medications is this: vaccinated persons already have much lower rates of hospitalization and death and are less contagious for a shorter period compared to unvaccinated, infected persons. Yes, hospitalizations and deaths still tragically occur but breakthrough infection is not perpetuating the pandemic. A pill will help them a little for sure, but is hardly a game-changer.

The problem was and remains to be the unvaccinated. Similar to the debate over vaccine boosters, which benefits mostly the already-vaccinated, the people most in need of oral Covid-19 pills – from both personal health and public health perspectives – are those who have refused a Covid-19 vaccine.

Covid-19 anti-vaxxers are a heterogeneous lot: some consider vaccine-induced immunity to be inferior; others hate needles, yet many distrust science and the government and politicians in equal parts and will never follow official guidance.

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    So what is the likelihood that they will hurry to take a new pill tested in less than a thousand people with uncertain side effects promoted by the same government and pharmaceutical industry they already revile?

    On this one, my guess is that the uptake of Covid-19 pills will be quite low. But bad guesses have been the hallmark of the Covid-19 pandemic since its inception. As the pandemic has demonstrated, you simply never know what will happen until it happens.