Doctors respond to frequently asked questions regarding Merck’s new COVID-19 treatment.
Over the past year, concerns regarding ending the COVID-19 outbreak have mostly focused on vaccine availability, effectiveness, and safety. However, Merck revealed in early October, promising new treatment options that might be administered as a tablet in the days following the onset of COVID-19 symptoms to prevent severe disease. This news, which many are applauding as a game-changer, is already beginning to shift the debate.
Merck has requested an emergency use authorization (EUA) for the pill molnupiravir from the Food and Drug Administration (FDA). While such authorization could be issued in a few of weeks, it is unclear who will receive it. But we do know that the business claims to have performed so well in a clinical trial that it ended the trial early so that it could apply for the EUA as soon as possible. According to a business press statement, the medicine reduced the likelihood of hospitalization and death in people with mild-to-moderate disease by half.
“It certainly has the potential to be a really important advance,” says Albert Shaw, MD, PhD, a Yale Medicine infectious diseases specialist.
“Other COVID-19 treatments, such as remdesivir or monoclonal antibodies against the SARS-CoV-2 virus causing COVID-19, are given intravenously. This is a pill your physician could write a prescription for, that you could pick up in a drugstore.”
Dr. Shaw and other infectious disease experts have shared their insights and answered some commonly asked questions about Merck’s new COVID pill.
How does Molnupiravir – the COVID-19 pill work?
It is essential to highlight that the pill should only be taken if you have COVID-19 symptoms. Molnupiravir was administered to research participants in four capsules twice a day for five days, beginning five days after patients had their first COVID-19 symptoms.
Dr. Shaw says that when the medicine enters your bloodstream, it prevents the SARS-CoV-2 virus from replicating.
The coronavirus’s genetic material is RNA. Molnupiravir’s structure is similar to the nucleosides (or chemical building blocks) needed to form the virus’s RNA. The medicine acts by integrating itself into the RNA during the synthesis process.
“This results in many mutations, or changes in the RNA genetic code, introduced into the viral RNA,” says Dr. Shaw.
“And when this RNA is translated into viral proteins, these proteins contain too many mutations for the virus to function.”
Molnupiravir – doest it have any side effects?
According to the data in the company’s statement, the medicine looks to have a clean safety profile, which means that no major adverse effects were observed in trial volunteers.
Because molnupiravir works by interfering with how the coronavirus replicates RNA, there is a risk that it will have a similar effect on human DNA or RNA. According to Merck, laboratory investigations show that molnupiravir does not cause mutations in humans, but “the FDA will obviously need to see and evaluate this safety data in the approval process,” Dr. Shaw says.
Dr. Shaw points out that some licenced antiviral medicines that are already in widespread clinical use, such as acyclovir and similar treatments for herpesvirus infections and reverse-transcriptase inhibitors for HIV infection, also function (though distinct mechanisms) to prevent viral DNA or RNA replication.
Jaimie Meyer, MD, MS – an infectious diseases specialist at Yale Medicine said that in its clinical trial, Merck didn’t test the drug on pregnant women.
“In the trial, not only did they exclude women who were pregnant, breastfeeding, or anticipating becoming pregnant, but they also told the men enrolled in the trial that they couldn’t have unprotected sex with women for a week after they were done with their medication,” she says.
The fear is that this medicine will interfere with RNA replication, which is required for fetul development, resulting in birth abnormalities. This will be critical to elicit as the medicine progresses from clinical trials to the market, she adds.
Is molnupiravir same like Tamiflu?
Yes, in function, ease of use, and availability, this new pill is comparable to Tamiflu, an antiviral medicine used to avoid serious flu symptoms. However, there is a significant difference, according to Dr. Shaw.
“Tamiflu works through a different mechanism—by interfering with the entry of influenza virus into cells—instead of targeting the reproduction of viral RNA,” he says.
Interestingly, Tamiflu also can be given in a single dose to prevent infection with the flu, “like a post-exposure prophylaxis [PEP],” says Dr. Meyer, explaining how some people may be prescribed antiviral medications after a potential exposure to a disease, like HIV, to prevent infection. “Molnupiravir has not yet been tested as a PEP against COVID-19,” she says, “but that would be a hope for the future.”
Does molnupiravir help prevent infection or severe illness and death?
Dr. Meyer explains that the Merck pill’s objective is to keep people out of the hospital.
“We want to prevent severe illness and death in people who are infected with mild-to-moderate COVID, but who are not yet hospitalized,” says Dr. Meyer.
According to the Merck trial, molnupiravir could help individuals with at least one risk factor for severe COVID-19 avoid hospitalization.
Who should take molnupiravir?
Merck is looking for an EUA for its high-risk adult pill. Molnupiravir was generally administered to individuals over the age of 60 or those who were younger but had additional illnesses that put them at high risk of serious outcomes from COVID-19, such as diabetes, heart disease, or obesity, in the clinical trial. The FDA will also assess whether it should be administered to vaccinated people; the trial solely included unvaccinated persons.
Does molnupiravir kill other virus variants, including Delta?
Yes, which may come as a surprise to many. The study, which was done in the United States and other nations, also indicated that the medicine would be effective against viral mutations classified as “variants of concern” by the Centers for Disease Control and Prevention (CDC), such as the Delta, Gamma, and Mu mutations.
Could molnupiravir be a turning point for other COVID-19 treatments?
So far, COVID-19 therapies have been difficult to get or have been ineffective.
“We don’t have a lot of COVID medications in our arsenal,” Dr. Shaw says.
Remdesivir, the only COVID-19 medication treatment that has been fully approved by the FDA, may only be delivered intravenously in a hospital setting. It’s also only for people over the age of 12, regardless of how bad their symptoms are, and studies suggest it may only provide a minor improvement.
However, other drugs for the treatment of COVID-19 are in the pipeline, according to Dr. Shaw. Pfizer, which developed the first COVID-19 vaccine to be authorised – and then completely licenced – in the United States, is anticipated to reveal findings on a potential protease inhibitor that would also be administered orally.
“Hopefully, there will be more tools to help us better treat our COVID patients,” he says.
Why was the trial stopped early?
The trial was discontinued on the recommendation of a data and safety monitoring board, an independent organization tasked with assessing the study’s progress at predetermined intervals.
“This is not uncommon in clinical trials,” Dr. Shaw says. “In consultations with statisticians, and without input from Merck, the board concluded that the results showing efficacy were clear and would not be affected by continuation of the trial—and, that the best thing would be to stop the trial and make the results known, so we can move forward.”
It’s important to note that at the time the study was stopped, they were 70% fully enrolled, “so they had data on nearly 800 individuals randomized to receive either the study drug or the placebo,” adds Dr. Meyer.
If molnupiravir is authorized, do we still need vaccines?
Both experts stressed that if and when molnupiravir is approved, and even if it is as effective in real-world circumstances as it was in the research, vaccination would remain critical for preventing SARS-CoV-2 infection and reducing its spread. Vaccinated people, they claim, have a considerably lower likelihood of becoming ill and requiring treatment.
“The vaccine is our first-line tool for preventing hospitalization, and I’m a little concerned that the attention on molnupiravir will draw attention away from vaccination,” says Dr. Meyer.
“Some people might say, ‘I’m not getting vaccinated because I’ll have access to these medications’—to this pill or to remdesivir or other treatments. But you can’t trade one for the other. If you haven’t done so already, the most important thing is still to get the vaccine.”
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