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'Maybe it's great — we just have no idea': Will Merck's anti-COVID pill live up to the hype?

According to Merck, its investigational antiviral halved the risk of hospitalization and death in a study involving 775 people with mild-to-moderate COVID-19

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What could become the first authorized pill for COVID-19 has “mutagenic” properties. It messes with the way the virus copies itself, causing hog-wild mutations. “The virus essentially mutates itself to death,” Georgia State University virologist Richard Plemper recently told the journal Nature.

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The federal government is already said to be in early negotiations to secure a supply of Merck’s molnupiravir, even though the drug has yet to be authorized by Health Canada.

According to a Merck press release, its investigational antiviral halved the risk of hospitalization and death in a study involving 775 people with mild-to-moderate COVID-19, compared to placebo.

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The claim, if it holds up to scientific scrutiny, would be impressive, and mark the first early treatment for COVID that doesn’t have to be infused or injected into bodies, doctors said. But over the last year and a half, other drugs such as hydroxychloroquine and the anti-gout pill colchicine have failed to live up to early hype. “When the data come out, they’re underwhelming. We have to be a little careful,” said infectious diseases specialist and medical microbiologist Dr. Donald Vinh, of Montreal’s McGill University Health Centre. And while a 50 per cent drop in the risk of hospitalizations and death sounds highly encouraging, he said, it’s not as impressive as vaccines, “which are at least 85 per cent effective at preventing those same outcomes.”

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“Maybe it’s great — we just have no idea,” said Dr. Andrew Morris, an infectious diseases specialist at Mount Sinai Hospital and University Health Network in Toronto.

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At a reported US$700 to $800 for a five-day course of therapy, the drug, assuming its side effect profile is favourable, couldn’t be given to everyone for their own personal supply, or stocked in every drugstore in the country, said Morris of the pill he has dubbed “Molly,” not to be confused with the recreational drug MDMA, or Ecstasy.

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“If you’ve got infinite funds and access to the drug, you’d say, ‘Okay, give it to everyone.’ But it doesn’t make economic sense,” Morris said. “You need to give it to the people who are highest risk. And you have to figure out, who’s the highest risk?”

The Merck trial, conducted with Ridgeback Biotherapeutics, involved people with at least one risk factor for developing severe COVID, such as obesity, older age (60 and up), diabetes and heart disease. All were unvaccinated against SARS-CoV-2. At 29 days out, seven per cent of the treated group had been hospitalized or died, compared to 14 per cent of those treated with a placebo.

The treatment window is finite. The pills have to be given to someone recently infected, who is diagnosed fairly quickly and with a confirmed positive test, and within five days of symptoms starting.

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If approved, doctors could be faced with having to choose between two treatments for people with mild to moderate COVID at risk of a bad outcome: monoclonal antibodies, one of the treatments famously used to rid then U.S. president Donald Trump of COVID that needs to be infused or injected, at $1,500 to $2,000 per dose, or the Merck pill, Morris said. “Do you send them to an infusion centre or somewhere to get a subcutaneous injection of monoclonal antibodies, or to the pharmacy for pills? And why do you choose one over the other? These are all quite challenging.”

What made some people so interested in drugs like hydroxychloroquine and ivermectin is that they’re dirt-cheap and widely available, said Morris. Ivermectin champions are already claiming on social media that Merck — which also makes ivermectin — has insisted there is no scientific basis for any potential therapeutic effect for ivermectin, no meaningful evidence of benefit against COVID-19 and a worrying lack of safety data, so that the drug giant could push its “miracle” antiviral. “Total nonsense,” Morris recently wrote in his COVID newsletter.

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Others have expressed concerns over whether the molecule produced by molnupiravir that allows mutations to accumulate in the virus could lead to problems in humans. Morris is not a virologist or molecular biologist. “But I cannot imagine that that’s an issue, because it’s not taken up in human cells the same way.”

Jennifer Chan, vice-president of policy and government affairs at Merck Canada, said all pre-clinical data — the toxicity studies — did not show any “untoward effects” at the doses studied in humans.

From the data to date, “the drug was generally well tolerated in terms of safety and side effects,” Chan added.

The drug inserts itself into the viral RNA, causing a phenomenon known as viral error catastrophe. It fools the virus, giving it the wrong building blocks to replicate. Canada was among the trial sites.

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“The way I sometimes explain it to people is, you’ve got a bricklayer building a house, and occasionally you’re handing the bricklayer some cardboard bricks. Clearly, the house ain’t going to stand with cardboard bricks,” Morris said.

Treatment requires two capsules a day for five days. The U.S. has ordered 1.2 million courses of the drug, at a cost of $1.7 billion.

Last November, Ottawa signed a $32-million agreement with Eli Lilly for up to 26,000 doses of its monoclonal antibody therapy, bamlanivimab. Five months later, the federal government issued a “failure” warning that the drug may not be effective against certain variants, but even before then most of it sat on shelves because there was no real strategy to implement its use and doctors weren’t clear on exactly which patients to treat. “The data was entirely unconvincing, and that proved to be the case as it was being sold to the government, for a variety of reasons,” Morris said.

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But governments are “damned if they do and damned if they don’t,” he said. “They have to make a decision around the procurement, knowing that it’s very possible that this (molnupiravir, Merck’s drug) is going to become a very popular agent.” Most provinces are also only starting to figure out how to give monoclonal antibodies to people, unlike the U.S., which has infusion clinics all over the country.

The people who would most benefit are the unvaccinated, Morris said. What’s not clear is whether the same people who have chosen not to be vaccinated, for whatever reasons, would agree to a new treatment that is newer and less tested still than the vaccines, “by a factor of hundreds of millions.”

Fewer than 1,000 people were enrolled in the phase 3 study of Merck’s experimental drug. More than six billion doses of COVID-19 vaccines have been administered globally.

But, “that’s the crazy thing — many people who are vaccine hesitant don’t seem to be hesitant of monoclonal antibodies, or ivermectin, or any of these other treatments, whether they’re useful or not. But there is something special about vaccines that they won’t take,” Morris said.

• Email: skirkey@postmedia.com | Twitter:

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