Could a bullet-shaped pill alter the course of the pandemic’s trajectory?
Drugmaker Merck said Friday that its experimental antiviral pill cuts rates of severe disease and death in half for newly diagnosed COVID-19 patients at high risk of becoming seriously ill.
If cleared by the U.S. Food and Drug Administration and other drug-safety agencies around the world, molnupiravir would become the first effective treatment for COVID-19 that can be taken in pill form. It would fill the gap between preventive strategies (masking, social distancing, and vaccination) and available treatments. All of these require expensive medical care.
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Molnupiravir is intended to be started soon after a patient develops mild to moderate symptoms of COVID-19. Clinical trials showed that the drug could reduce the length of illness and the severity of symptoms, which can lead to hospitalization or death.
Merck, along with Ridgeback Biotherapeutics were able to obtain FDA emergency authorization. If the FDA approves it, millions could have access to it at home before the end of this year.
Health experts from Dr. Anthony Fauci on down have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the decades-old Tamiflu helps fight influenza. These medications are key to preventing future outbreaks of infection and minimizing the impact of the pandemic.
“Nothing is as easy as giving people a prescription to take home, so I think it has extraordinary potential,” said Dr. Jeanne Marrazzo, who directs the infectious diseases division at the University of Alabama School of Medicine in Birmingham.
Pills like the malaria drug hydroxychloriquine and the anti-parasitic medication ivermectin seem to hold special appeal among the unvaccinated, Marrazzo said. She said that many patients are still clinging on to unproven treatments. “It would be my prayer” that they could find one that is safe and effective.
Merck’s clinical trial tracked 775 adults who were considered to be at higher risk for severe disease because they had underlying health problems such as obesity, diabetes and heart disease, or they were over 60 years old. Participants were given eight pills per day for five days. They didn’t know if they received the experimental drug or a placebo.
Among 385 patients taking molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of the 377 patients who got the dummy pill. Merck stated in a statement that there were no deaths during the study period. This compares with eight deaths in patients who received the placebo pill. Merck stated that it plans to present the full results of its study at an upcoming medical meeting.
The trial was stopped by an independent medical group after the initial results were strong. This is what happens when the initial results are so strong that authorization is not required.
Earlier study results showed that the drug did not benefit patients who were already hospitalized with severe COVID-19.
Roughly 40% of participants’ viral samples were genetically sequenced, revealing that several coronavirus strains were present among those enrolled in the international study. Merck stated that Molnupiravir had “demonstrated consistent efficacy over viral variants Gamma and Delta” (Merck).
This finding highlights one pill’s key characteristics: the ability to fight SARS/CoV-2 as it evolves.
Molnupiravir appears to work by disrupting the coronavirus’ ability to replicate itself inside of human cells. The drug tricked the virus into reproducing its own recipe. It then created a program that generated so many mutations that the virus eventually died.
This strategy of inducing “lethal mutation” seems to not only work on SARS-CoV-2, but also on other coronaviruses which plague humanity with respiratory diseases ranging from deadly pneumonias to the common cold. It also has been shown to block alpha viruses, such as the Ebola virus or equine-encephalitis.
By targeting a portion of the coronavirus common to all pathogens, this compound “is more of a generalist rather than a specialist,” stated Dr. Mark R. Denison ,, a Vanderbilt University microbiologist who did some of the initial lab work that led to the drug’s creation.
“This is a wonderful fact, he said. It means that molnupiravir should work with all types of coronavirus. The skeletal trial results were released on Friday and showed that the red capsule had no signs of side effects. Drug-related adverse events were seen in 12% of those taking molnupiravir and 11% of those who got the placebo, Merck said. Merck stated that only 1.3% of the subjects who took the antiviral medication with worrying symptoms withdrew from their trial. 3.4% of those who received the placebo did so.
Two antibody treatments are currently available for COVID-19 patients with mild to moderate disease. Each must be administered intraveneously and requires a visit to a hospital.
One FDA-approved antiviral, remdesivir, has been approved as treatment for COVID-19. It is only used in patients who have already been diagnosed with COVID-01.
If molnupiravir is added to the formulary it could be targeted at people who are more likely to become seriously ill. This would not only prevent some deaths, but also reduce hospital strain.
Once Merck has submitted its emergency use authorization application, the FDA may make a decision in a matter of weeks. If approved, the drug could soon be on the market.
Merck only studied the drug in unvaccinated patients. But FDA regulators may consider authorizing it for broader use in vaccinated patients who get COVID-19 symptoms. Dr. Dean Li, vice-president of Merck Research Laboratories, stated that the drug performed better than I expected it to in this clinical trial. “When you see a 50% reduction in hospitalization or death, that’s a substantial clinical impact.”
The company expects to produce 10 million courses of treatment by the end of 2021, with more in 2022. The U.S. government has locked in the purchase of 1.7 million courses of the drug.
Merck has also said it would license the production of molnupiravir to established generic drug manufacturers “to accelerate availability” of the pill in more than 100 low- and middle-income countries.
Several companies, including Roche and Pfizer, are also studying similar drugs. They could report their findings in the coming weeks or months.
The Associated Press contributed to this report.