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Research Patient Care COVID-19 SOP Shared

New Pill Is a Potential Game-Changer in the COVID Battle, CU Anschutz Expert Says

Professor Peter Anderson, PharmD, expects oral treatments to become a trend, ‘a cocktail way we treat COVID patients’

Author Chris Casey | Publish Date October 12, 2021
What You Need To Know

The news of the first antiviral pill to treat COVID-19 is a “very exciting development,” says Peter Anderson, PharmD, a professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences at CU Anschutz. He believes that oral pills taken at home, in combination with other medications, are the future of COVID treatments.

Vaccines remain the best shield against COVID-19, but for those who’ve been infected with the coronavirus, the treatment arsenal continues to expand. This month, the first antiviral pill to treat COVID was submitted to the Food and Drug Administration (FDA) for emergency authorization.

Merck & Co. developed the oral pill in conjunction with Ridgeback Bioetherapeutics, which in January 2020 submitted the drug, whose chemical name is molnupiravir, for treatment of seasonal influenza. When the COVID pandemic struck, the company shifted the drug’s focus on coronavirus.

Vaccination definitely is the umbrella over everything. But if we can treat COVID with these oral medications, I think it changes the efficiency of care altogether. – Peter Anderson, PharmD

 

Until molnupiravir, which is being distributed to several other countries and possibly in the United States within a few weeks, only the antiviral agent remdesivir, a few monoclonal antibody medicines and a smattering of anti-inflammatories and blood thinners have been available to treat COVID cases. Remdesivir and the anti-SARS-CoV-2 monoclonal antibody treatments are administered via intravenous infusion, requiring a trip to a clinic or hospital.

Peter Anderson, PharmD, a professor in the Department of Pharmaceutical Sciences at the Skaggs School of Pharmacy and Pharmaceutical Sciences and an expert in the prevention and treatment of HIV infection, said molnupiravir’s efficacy is “a very exciting development” and expects that oral pills taken at home, in combination with other medications, are the future of COVID treatments.

“These oral drugs could have much more impact than the infusions,” Anderson said. “They can reach so many more people.”

Besides the unvaccinated, who remain the most susceptible to COVID, there are millions of people in the United States who are immune-suppressed and may not be able to mount a full, protective immune response after vaccination.

Molnupiravir underwent a randomized trial on adults with mild-to-moderate cases of COVID-19. The drug reduced the risk of hospitalization by about 50% in unvaccinated adults who had shown early symptoms and were at high risk for unfavorable outcomes from the virus. Over a span of almost a month, no deaths occurred in the patients who received the drug, but eight died in the placebo group.

While emergency authorization could be several weeks away, the news media reports that the government has already advance-ordered pills for 1.7 million Americans, at a price of about $700 per patient, about a third the cost of a monoclonal antibody treatment.

In the following Q&A, Anderson comments on the outlook for molnupiravir, as well as other SARS-CoV-2 treatments emerging on the horizon.

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What is your initial reaction to the development of molnupiravir as a treatment against COVID?

I think this drug is very exciting, and then there are two others (antiviral oral pills being developed by Pfizer and Atea Pharmaceuticals-Roche, respectively) that are not far behind, so we need to see if those other two work. But this just makes treatments so much easier for everybody – clinicians, patients – because all we have now are infusions. This opens the door for ambulatory treatment (of COVID-19).

What did you think of its efficacy in the clinical trial?

I thought it was really quite exciting. They stopped the trial early because there was overwhelming evidence that it worked. I think it’s very encouraging.

Do you think oral pills will become a new trend in the treatment of SARS-CoV-2?

Yes. Vaccination definitely is the umbrella over everything. But if we can treat COVID with these oral medications, I think it changes the efficiency of care altogether. And I think that’s the way we’ll head. We’ve got antibodies, but you have to be hospitalized or go into a clinic for an infusion.

In the HIV world, where I came from, I can see the parallels for treatment. With COVID, it started with one drug: remdesivir, the very first one administered in the hospital to very sick patients. By itself, it didn’t have that great of an effect, much like AZT (the first HIV drug). And then with the subsequent drugs, it’s incumbent that they improve. Additionally, for HIV, we learned the advantages of combination therapy. It’s synergistic when you use a combination of drugs that work on different parts of the virus. It might be where we land one day (in the fight against COVID).

How does molnupiravir work against SARS-CoV-2?

The virus has to replicate its genetic material – that’s a key for all viruses. So, this drug causes the virus’s genetic material to incorporate genetic errors. The virus becomes non-viable because there are so many errors built up. In HIV, this same class of drugs (nucleoside analogs) causes the genetic chain to stop. (Molnupiravir) is a little different, but it’s a direct-acting antiviral, so it works right on the virus, not on the immune system like some of the other (COVID) drugs you hear about.

And it’s shown to be effective against SARS-CoV-2 variants, including delta and gamma?

Yes, so far it works against the variants.

What about Merck’s ability to produce enough of the medicine? Is there an ability to make large quantities of the drug?

Yes, I think that’s another really advantageous feature. As I understand, it’s actually pretty easy to synthesize – to perform the chemical process – so unlike remdesivir, which has a lot of steps that go into the final product, this one is just a few steps. So, it should be easy to manufacture in bulk. Merck said in a press release they expect to have 10 million doses ready by the end of the year. It shows pretty good scale-up.

Are there any potential side effects or potential warning signs about the drug?

Because of how the drug works, you want to be sure you don’t introduce errors in the genetic material of our (healthy) cells, and Merck has done some studies and demonstrated that there is no evidence of that. You do the animal studies before you go into human (trials), and the animal studies also look good.

You also want to get longer-term safety information. They’ll have to do things like ensure that it is safe in people who want to become pregnant – both men and women (enrollees in the recently published trial were instructed to abstain from sex or use contraception). I think there is a little more work to be done to dot your I’s and cross your T’s with the safety studies, but so far, in the human studies, it looks safe.

A few countries – Australia, Singapore, Malaysia and South Korea – already have agreements to buy molnupiravir doses even though, at least with the FDA in the United States, regulatory hurdles haven’t been fully cleared. Does that surprise you that some countries are going ahead with ordering supplies?

I think COVID has changed things a little in that regard. The vaccines, the antibodies, etc., were all relatively fast. I do think some of our practices have sped up a little bit, but we are still using due diligence for reviewing safety and efficacy. With the countries that are moving fast, I’m sure they’ve got their experts looking at (the drug) and doing their best (to analyze its safety and effectiveness).

What do you think about the wave of misinformation that has convinced many people that they know more about how to treat COVID-19 than the medical establishment and experts, such as the push for use of ivermectin?

It goes to trusting experts again. Ivermectin is a replay of hydroxychloroquine. The exact same thing happened. I understand the confusion in the public because there are studies that were done – but they were done poorly, and not well peer-reviewed. These make it into the literature, and people point to them, but some have ended up being retracted because scientists found flaws (in the research). And so now there’s all this confusion. But the experts that we talk about, they sift through all of the data from all the studies. They found significant errors in the ivermectin studies people point to. So, we have to rely on these experts. These are the best of the best in our field who are reviewing these studies and the recommendation is not to use ivermectin for COVID-19.

Would you describe molnupiravir as a possible game-changer in the fight against COVID?

I think so; I was impressed with the results. You can’t question the result, and they stopped the (most recent) trial early. I think what we’ll see in the future is molnupiravir will become part of a cocktail way that we treat COVID patients. I think this is a very exciting development; it clearly works in the population they studied.

It’s exciting, too, that they’ve got other studies going with prevention, using molnupiravir to possibly prevent COVID. I think that could be really important as well. I think molnupiravir brightens the future of managing COVID.

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Peter Anderson, PharmD