Promising Data on New COVID-19 Therapeutics

John Whyte, MD, MPH; William Schaffner, MD


November 19, 2021

Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

JOHN WHYTE: Welcome, everyone. You're watching Coronavirus in Context. I'm Dr. John Whyte, the chief medical officer at WebMD.

What about drugs to treat COVID? We've been hearing a lot about them lately. And how likely is it that if you or a loved one needs one, you'll be able to get one soon? So joining me is Dr. William Schaffner. He's professor of medicine at Vanderbilt University Medical Center. Dr. Schaffner, it's great to see you again.

WILLIAM SCHAFFNER: Hi, John. Always good to be with you.

JOHN WHYTE: I'm going to start off with a little bit of a curveball. We've been talking now for 20 months, even on multiple episodes. Are you surprised it's been this long?

WILLIAM SCHAFFNER: My biggest surprise came when we hit the wall regarding vaccinations. I had no idea they would be so many people who would be so skeptical, hesitant, and frankly downright stubborn about not receiving these vaccines, which are so very, very effective. That's so different than back in the 1950s and the 1960s. When we had measles vaccine and the polio vaccine was rolled out, people had this trust in science; trust was key. And parents brought their children out to be vaccinated. There were great long lines. I remember I received the button. I was a polio pioneer when I received my sugar cube with the live polio vaccine. Today, people are much more skeptical, I'm afraid.

JOHN WHYTE: Well, this brings us to the issue that we're going to have a certain percentage of the population that is not going to get vaccinated no matter what. That may allow the virus to continue to live, continue to mutate. And we're at the point where we all kind of acknowledge it's going to be endemic, always around, so we need drugs to treat. And some have done OK in terms of what we've seen so far, but there's two promising new therapies. And I want to go over each of them if I with you and get your input on it.

And I want to start with molnupiravir, which is a repurposed drug, correct? It was originally used for influenza and some other diseases. Can you talk about how molnupiravir works as an antiviral?

WILLIAM SCHAFFNER: Well, antiviral drugs -- and think of them as roughly analogous to Tamiflu. Basically, what they do is once the virus has established an infection and it's entered some of your respiratory cells. The next thing if we could get a drug that interfered with the virus's multiplication, then we could limit the spread of the virus internally in the body and we could shorten the duration of the disease and make the illness less severe. And that's the general concept of an antiviral. You have to be infected first, but then when you do get infected, if you get the drug there early, you can prevent the evolution into a more serious disease.

JOHN WHYTE: Because what Merck did is, they looked at 775 adults -- mild, moderate COVID. And what they found, these were people early on, within 5 days of their symptoms, it was one-half the rate of hospitalizations, 7.3% of people receiving molnupiravir were hospitalized within a 30-day time frame, versus 14% in placebo. No deaths in the group that got molnupiravir, eight deaths in those that received the placebo. Folks were so impressed with this that an independent data safety monitoring board stopped it early and said, "We need to get this to the FDA." Is this drug potentially a game changer?

WILLIAM SCHAFFNER: People talk about a game changer; I guess, in a sense, it might be. Now, we potentially would have a medication. Some pills, you could take them -- pick them up at your local pharmacy, or we could even develop innovative ways to get that medicine to you. We could have it delivered right to your doorstep by FedEx or UPS.

Now, there is a regimen. For that Merck drug, you have to take four pills twice a day for 5 days in order to achieve the maximum benefit. And of course, you have to start very, very promptly. So you have to get your infection diagnosed and you have to get that result to a health care provider that will actually certify that you're eligible for the medication. And exactly how we set that up, we're not entirely sure yet.

JOHN WHYTE: I want to ask you that because I thought this was interesting, Dr. Schaffner. An early study did not show any benefit to patients who were already hospitalized with severe disease. Why do you think that's the case? Do you think they were just too far along in replication of the virus that it wasn't able to stop it in time, or is that something that we have to pause for in terms of interpretation of this data?

WILLIAM SCHAFFNER: John, I think that emphasizes how important it is to get the medication to people early, because that's very similar to monoclonal antibodies. You've got to get to this viral infection and try to curtail it before it disseminates and before it can set up that second phase of the infection in our bodies, which is to rev up that big inflammatory response, which in and of itself causes damage. So you want to get it early in the viral part of the illness.

JOHN WHYTE: Every drug as you know has risks and benefits. Some people are pointing out, by the way, that it works something called mutagenic, that it basically causes mutations. Would we have to be concerned, do you think, about cancer risk or some other impact this may have?

WILLIAM SCHAFFNER: I know that the Food and Drug Administration has been very concerned about that, and at the moment, in the animal studies and the large but not huge human trial that we have, there's no evidence of that. But there are two sides to every equation, right. There's the effectiveness side, which we've been discussing, and the safety side. And we'll want to see those data displayed as they go to the FDA. And that's something that we will have to monitor clearly going forward.

JOHN WHYTE: Another drug, as we were talking about before we came on today show, from Pfizer, Paxlovid, 90% effective is the data that's currently being reported at preventing severe COVID symptoms when given to high-risk patients, again, early on within those first few days. This drug interferes with the ability of the virus to replicate. It's often given with an older drug for HIV, an antiretroviral. Are we learning from HIV in terms of how we treat COVID that we might need multidrug regimen?

WILLIAM SCHAFFNER: Well, those things are possible because we do use multidrug regimens for HIV. Viruses are much harder to treat than our bacterial infections, and that's why the science has been a little slower in getting us these antivirals. But the science was great and very rapid with the vaccines, and it's now gratifying to see that the science is bringing us some assistance on the therapeutic side also.

JOHN WHYTE: As you know, this was a drug given with ritonavir, which, as I mentioned, is used to treat HIV. They had 1,200 participants with COVID at high risk. They had no deaths in the experimental group and 10 who received the placebo group. How do you know when is enough data to say we need to move on and get this to the general population? We're still having a lot of cases, still too many deaths on a daily basis.

WILLIAM SCHAFFNER: Well, we need to remind ourselves, if we need reminding, that we are still in a pandemic circumstance. There are 1,000-plus people dying of this infection daily, over 700,000 have died since the beginning of this pandemic. It's still continuing to spread very rapidly and intensely among unvaccinated people.

So we're still in a crisis mode here. We can't put up “mission accomplished” by any manner or means here. So we're still working hard to try to get ahead of this virus. So I think people are more apt to go ahead and look at data rigorously but not require as much as they might want to see in a circumstance that were the old normal, shall we say.

JOHN WHYTE: But we could point out, Dr. Schaffner, billions, billions of people have received the vaccine, and people are hesitant about it. And then if we have a therapeutic, which is tested in a few hundred, people seem to be more willing to take that. Does that drive you insane at times?

WILLIAM SCHAFFNER: Well, it is a remarkable part of human psychology, John, that I've tried to get my brain around and I don't completely understand. But people seem to be ready to accept therapies that are much less well-treated and oral medications as opposed to injectable preventives. So there's a human psychology there that's very evidently at work.

JOHN WHYTE: Well, Dr. Schaffner, you and I have been talking for 20 months. You've been advising us at WebMD and Medscape as well as the general public. I want to thank you for all that you're doing to help keep us safe. It's information that we need, and you present it in such a conversational as well as compelling way. So I want to thank you for that.

WILLIAM SCHAFFNER: You're very kind, John, and I want to thank you and everybody at Medscape because you're helping getting the information out. We're partners in this.

JOHN WHYTE: And if you have questions, drop us a line. You can post on any of our social properties or email me at Thanks for watching.

This interview originally appeared on WebMD on November 19, 2021

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