TWiV 895 COVID-19 Clinical Update #112

This Week in Virology

Host: Vincent Racaniello

Guest: Daniel Griffin

Aired 30 April 2022

Pdf of this transcript available (link)

Vincent Racaniello: This Week in Virology, the podcast about viruses, the kind that make you sick.

[music]

Vincent Racaniello: From MicrobeTV, this is TWiV, This Week in Virology, Episode 895, recorded on April 28th, 2022. I’m Vincent Racaniello, and you’re listening to the podcast all about viruses. Joining me today from New York, Daniel Griffin.

Daniel Griffin: Hello, everyone.

VR: It’s update Number 112. Can’t wait to hear the hot off the press with Daniel.

DG: [chuckles] As you’re referring to, Vincent, I sent you my update about an hour ago, and then I had to update it again. Stuff keeps happening, but let’s get right into it. We have a lot to cover today. “Yesterday is not ours to recover, but tomorrow is ours to win or to lose,” and that’s by President Lyndon B. Johnson. Spending last weekend down in D.C. had me thinking about presidents, and that directed me this way. Also thinking about, hopefully, we still have a bit ahead of us here and we can learn from what we’ve done in the past, and we can see some success going forward.

The first part of our update is expanded access in education for COVID therapeutics. I love the fact that they’re actually throwing education in there. People want to know. [chuckles] They want to be educated about their choices and options. The U.S. government has a plan aimed at getting the pill. Actually, it’s very Paxlovid-focused, the pill called Paxlovid to additional people who otherwise could face a more serious COVID illness. Couple points in this plan, the White House wants healthcare providers to err on the side of prescribing the pills, rather than worrying about scarcity. If you’re not sure, if you’re on the fence, go ahead, prescribe it.

Just a couple other things. As of April 25th, Paxlovid was already available at about 20,000 locations nationally. The goal is to get this up to 30,000. The goal on where will these drugs be? The idea is to have them available at pharmacies as part of this test and then treat, or test-to-treat program. Go in, get your test, and immediately have access to the therapeutics. Community health centers, urgent care centers, veteran affairs clinics. Just to talk a little bit about the logistics on this. Actually, one of my friends, Hadia Farooq, a hospital-based pharmacist, she was actually saying that some of her colleagues out there in the private pharmacies, the retail pharmacies as we call them, they’re a little overwhelmed already.

They were not sure how excited they were. It might make more sense, for those of you listening, in policy level positions. The urgent care centers are a little quieter now than they had been over the past couple of years. An ideal spot for someone to go, get that test. Have a clinician, a provider, be able to talk to them about the pros and cons. People like a little bit of education. May also be an opportunity if needed to send off that kidney testing bloodwork. Also, an opportunity to look through the other meds. Maybe make some clinical decisions, like, “Is it OK to stop that low-dose hypertension medicine, or maybe that cholesterol medicine for a week or two?”

That might make a little bit of sense, but it’s only going to make sense if those packs of Paxlovid are sitting there in those urgent cares. Also, some of our ERs, I think I’ve mentioned, have them sitting there. People show up, they get the test. You’ve got a clinician who can work through this with them. Just editorializing a little bit. If we’re going to make this work, we really have to think through the logistics. We’ve really asked our pharmacy colleagues to do quite a bit here. Sometimes it’s nice to think it through, make sure it works. Then one, and this will be to the pharmacy colleagues.

If that ER doc, actually my buddy, Dr. Kaplan, who’s the head of one of the Northwell ERs, he and I were talking earlier today, he would send someone, send the Paxlovid prescription and then they would get a call back from the pharmacy wanting to talk to the ER about kidney function. He’s like, “Listen, this is an ER. If I’ve made a decision to start them on the medicines, I’ve checked that.” It can be tough. The pharmacist has to do their due diligence. They don’t want to give someone something, but maybe the phone call back to the busy ER is not the best logistics here.

Let’s go to children. We’ve got a lot on children, COVID, and vulnerable populations today. I will be talking hot off the press about some new news about vaccines for those under five. Children are at risk for COVID. Summer is coming up, camps, and all these other things around the horizon. We will have some exciting news on our therapeutic section as well, but let me start off with what is maybe not so positive. This is the MMWR early release, “Seroprevalence of Infection-Induced SARS-CoV-2 Antibodies, United States, September, 2021 to February, 2022.”

This is an MMWR early release. I’m going to go through what they have to say, but also I want to have a little discussion about how to interpret this data. A lot of media attention focused on this. This is the results of the National Commercial Laboratory Seroprevalence Study, which is a cross-sectional national survey that estimates the proportion of the population in 50 U.S. states, the District of Columbia, and Puerto Rico. Sorry, it’s 52 different places, that have infection-induced antibodies to SARS-CoV-2. What they’re doing here is, sera are tested for anti-nucleocapsid, so antiantibodies.

These are produced in response to infection, but not produced in response to any of the COVID-19 vaccines currently authorized here in the US. Here were the numbers, based upon the seroprevalence as of February, 2022– Theoretically, this is a little bit higher. 0 to 11 years of age, 75% were positive. 12 to 17, 74% were positive. Age 18 to 49, 64% were positive. Age 50 to 64, about 50%, and those aged 65 and over, about 33%. I have a nice figure in there that I’m sharing here with Vincent. A few comments, I’ll get Vincent to jump in as well. One is, these are convenient samples, not random samples.

Why are these people going and getting their blood drawn? That may suggest that this is a population that’s interacting with the healthcare system a little more than your random person. Maybe these numbers are a little high. The other side is we know the sensitivity of serology and the durability of a “positive test” is not 100%. That would be the side saying, “Maybe this is an underestimation.” Vincent, any thoughts?

VR: I think the concern about a convenience sample is important. I’m struck by the decreasing seroprevalence. I was going to ask you what you thought about that. If it’s correct, what would be the reason why as you get older, we see the seroprevalence going down?

DG: My one thought might be maybe the older folks are less social. I think we’ve seen the social networks. Maybe I’m at heart a 70-year-old because I somehow have not gotten COVID, which means I must not be social. I think that a lot of people under the age of 50- I think we can lump them all here. The majority of people under the age of 50, if you take this data at face value, are having positive serology tests on this convenience sample. Much more social contact, much more need or choice to be out there in higher risk situations.

If you’re in your 70s or 80s, you might be able to shelter at home. You might be able to turn down some of those social invites. You’re not necessarily needing to go into a workplace or other higher risk settings. You’re not delivering food, or landscaping, or some of these. Those would be my thoughts.

VR: Obviously, the kids are all in school, so that would give you a high seroprevalence. 50 to 64 years, they should be working, so it’s funny that it’s 49.8%.

DG: It’s interesting. We try to say the schools are safe, Vincent. I’m going to suggest it’s the play dates in the suburban homes. [chuckles]

VR: Good point.

DG: Now this is the hot off the press. This is what required the quick update today. Moderna files for authorization of its COVID-19 vaccine in young children, six months to under-six years of age. We’ve already talked about the data here. This is based on the interim results from the Phase II/III kid COVID study. This was announced March 23rd, 2022. We talked a little bit about the “robust neutralizing antibody response” in the six months to under-six years of age after a two-dose primary series of the mRNA-1273. That’s the Moderna vaccine favorable safety profile.

Couple things I will say here. A lot of this is, we are filing and by the way, here’s a recap of what we showed before. There was a little bit of an update when I looked at the prior press release and I looked at this one. They did do another analysis where they were saying, “We’re going to look at cases where there was confirmed positive SARS-CoV-2 by a central lab with an RT-PCR,” because our listeners may remember, probably not, but home tests were allowed in the initial analysis that we talked about, still seeing a vaccine efficacy at 51% for the six months to less than 2% that was the best. Only 37%, I say only, for two to less than six years.

Remember, this is vaccine efficacy against, I’m going to say, symptomatic COVID. It was all mild symptomatic. There was really no severe disease, no hospitalization, no death in anyone, either side, placebo or vaccinated here, so we really don’t get any comments on that. That certainly leaves open the issue is- we’re not trying to just prevent infections, we’re trying to prevent severe disease. It’s going to be hard in one of these studies to get that data in a population that has a relatively low risk compared to adults of hospitalization and severe disease.

The EUA submission is going to be completed next week. That 15-day clock then starts, but Moderna just like Pfizer is also looking at booster doses. The suspicion down the line is that this will either be a farther-spaced from first to second, or really a three-shot series like it’s becoming for most of the other folks, particularly in the face of variants.

VR: I worry that because we can’t assess severe disease, hospitalization, death, that they will say, “Oh, we need to prevent infection in these kids,” and you know that’s not a viable strategy, as you’ve said.

DG: No. I think that’ll be a challenge, and it may be that we almost have to wait until after this is out there in the world next winter to be able to start seeing the differences, because we have had tens of thousands of children hospitalized, and so you will start to be able to see fully vaccinated kids. That will be anticipated. Testing. Never miss an opportunity to test, but test wisely. There’s a lot of debate going on, I think about, can you end your isolation early with testing, and should you extend it longer with testing? At some point maybe we’ll get back on that, but I just like to — my favorite quotation now, “Occam was not a physician, John Hickam was.”

Just because you have a positive flu or a positive COVID test, you could have something else. Let’s all keep that in mind. Still the pre-exposure period, how do we stay safe? I think the big thing now is the discussion of one-way masking. If you’re an older individual or an individual that has risk factors, there still is the possibility of doing one-way masking. If you have concerns, so wearing those– I don’t really like they say high quality. All the masks are very good quality. It’s just a question of what type of mask, so the KN95, the N95.

That might be the way that you can be in one of these situations with a lot of unmasked individuals, so just keep that in mind because, as I was having a conversation with my parents yesterday, I’m not sure how much better it gets than where we are now. We’ve got very effective vaccines, we’re about to extend them down to the under six. We have Evusheld, which we’ll get to for passive vaccination. We’re now getting to the point where we have effective antivirals, better access to those, so for a lot of folks, it’s going to be making these decisions about when do you start re-engaging in a lot of situations.

Active vaccination. The paper “Public Health Impact of COVID-19 Vaccines in the U.S.: Observational Study,” was just published in the BMJ. This was an observational study looking at the impact of vaccination on mortality. The investigators really are using CDC data, so they’re looking at CDC data on COVID-19 cases, deaths, and vaccinations. They tracked mortality as the primary outcome. They found that a 10% improvement in vaccination coverage was associated with an 8% reduction in mortality and a 7% reduction in incidence, interesting. Higher vaccination coverage levels were associated with reduced mortality and incidence rates.

You could almost calculate the efficacy of the vaccines with these impacts, so nothing surprising here, but all the caveats of an observational study. Passive vaccination. Remember, we talked last week about Evusheld and the intramuscular AZD7442 tixagevimab, so gevimab for prevention of COVID-19 that was published in The New England Journal of Medicine, not only an 80% reduction in symptomatic COVID on top of what we were already getting from vaccines. You’ve got your vaccines and another 80% reduction, but all the severe cases, critical and all the deaths for COVID-19 occurred in the placebo group.

I just want to point out the e-way. I feel like maybe– I don’t know if we can take all the credit, but someone’s doing something because the interest in Evusheld seems to have shot up. Remember, the e-way for Evusheld. These are individuals who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, and may not mount an adequate immune response to COVID-19 vaccination, or for whom there’s some reason that we can’t vaccinate them. Remember, you don’t have to prove. We’re not checking antibody levels. We’re not depriving them of this therapy if their antibodies are at some certain level.

Remember, we have no FDA-approved serology test that could be used for that purpose. Pretty exciting this week, our large healthcare system here, Northwell, a shout out to Northwell, they just launched an online portal yesterday for providers. They can go to the website that we’ll put in our show notes. This is great if you’re in a Northwell area. Maybe some other healthcare systems will mirror this, but you go online, you put the information in, the patient can be scheduled and they can get their Evusheld. The period of detectable viral replication. This is exciting.

Monday, April 25th, the US FDA expanded the approval of the COVID-19 treatment, VEKLURY (remdesivir) to include pediatric patients 28 days of age and older, weighing at least three kilograms, about seven pounds, with positive results of direct SARS-CoV-2 viral testing who are either hospitalized, not hospitalized. This makes remdesivir the first approved COVID-19 treatment for children less than 12 years of age, so a good week for the youngest in our population. Let’s just run through this because this is really the beat of this new initiative. We now have effective tools when a person tests positive.

Number one, remember, and this is an order, and the order changed this week, so a little excitement there. Number one still, Paxlovid. Remember about a 90% reduction in progression. Just remember, the e-way for Paxlovid is for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age and older, weighing at least 40 kilograms, so this is not for the under 12. A couple of things I want to comment. Paxlovid is not authorized for treatment in patients requiring hospitalization due to severe or critical COVID-19.

This is a little different than people getting admitted with mild or first-week viral symptoms from COVID-19. There’s no limitation on the use there. This potentially as per the EUA could be used in that setting. I think this is that important distinction that we’re starting to talk about and starting to see in the guidance is, early on, the only people that were getting admitted with COVID were people second-week, they were hypoxic, they required pulmonary support. We are seeing more, let’s say, frail individuals getting admitted maybe in that first week because they’re having GI issues, they’re not hypoxic, they have not progressed to the early inflammatory phase, the severe critical COVID-19 phase.

There’s nothing in here that says if you get admitted for that first week of COVID, that you can’t get Paxlovid. The other thing I will say is they are not requiring symptoms. If this is a high-risk individual, you don’t have to somehow get them to admit to a symptom or not. This will be the last thing that comes up a little bit with regard to Paxlovid. Paxlovid is not authorized for use longer than five consecutive days. Now, Vincent, I don’t know if you’ve caught wind of this, but initially, I delayed doing interviews till I could get a handle and talk to my providers about this.

There are a few individuals out there, it seems to be a small percent, where they get acute COVID, they’re symptomatic, they have a positive test, they take Paxlovid for five days. Usually, about day two or three, they’re feeling better. Maybe they even go ahead and get a negative test at about day 11 or 12, and then 10 to 14 days later, they start feeling crummy again. Not as crummy as the first time, but crummy again, test positive again. Now interesting enough, I waited till I had talked to a bunch of different providers, had heard about half a dozen of these cases.

Couple of things. This was actually seen in the trials. I didn’t know that until- actually it was a Bloomberg reporter, thank you, for steering me this way. Actually, they even sent me the [laughs] information so that was helpful. We’re not thinking this is due to development of viral resistance. It just looks, and I use the analogy of a urinary tract infection, not everyone is going to be able to clear the virus and get through this with just five days. For me, this is not surprising, we often run into this in medicine where some people may need a second course of treatment. It’s a little tricky right now under the EUA, but Vincent, as a virologist, any thoughts, any comments?

VR: Yes. I’ve heard of this also is, we were asked about it last night on our live stream and I said I would ask you what you thought, but it seemed to me that there’s no evidence for viral resistance. I’m not sure why they say that because to do that, you’d have to isolate virus and check it for resistance in vitro. That needs to be done in a BSL3. There are very few places that can do that right away, but I think, well, your explanation is perfectly reasonable, that five days is just not enough for everyone. Yes.

DG: No, that’s a good point. People have- it was actually a virologist, we won’t name who it was, but they actually they had the sample before they got Paxlovid- and they sequenced. That’s sequencing. I thought that was pretty good. Apparently a couple times, but we really want to do that.

VR: We don’t yet know what changes confer resistance, right?

DG: Yes. That would be the issue with relying on that. [laughs]

VR: You could say, oh, there’s a change in the protease, the target of Paxlovid, but you’d really need to know as you know for HIV, you know which mutations confer resistance to which drug, so you sequence. We’re not quite there yet, but first- and I know that there is a lab here in New York City who could readily do the sensitivity testing.

DG: Oh, yes. There’s a lab, you’re recording in not too far from it. You used to record like what, just [laughs] couple floors below.

VR: There are several labs here in New York that could do that so I expect that it’ll be done reasonably, and then once we know there’s no resistance- but I do think we need to find out what changes are associated with resistance as well.

DG: Yes. Certainly important to track, because what do you do when that happens? Do you switch to an alternative? These people tend to be doing pretty well so maybe you don’t even need to do anything at that point. Important to know.

VR: In these individuals, they feel crummy and then they get better again?

DG: Yes, and that’s the nice thing. At least so far what we’re seeing is that second, oh, I started to feel crummy again is not as bad as the first week of symptoms when they get the first treatment.

VR: But they’re not treated again, are they?

DG: So far no. Number Two is now remdesivir changed, the order has changed. Remember, before it was monoclonals, now remdesivir has risen to level two, the order has changed. Actually, this is going to present some challenges, hopefully challenges we will rise to in the spirit of Lyndon Johnson. We have the three-day early IV data suggesting about an 87% reduction in progression if given in those first five days. I have to admit, a lot of times this is what we’re doing if those folks end up in the hospital in that first week because it’s licensed, we can go ahead and do it, they’re at the hospital so it’s easy to get the IV access. There’s plenty of remdesivir around.

Remember now, this is the pediatric option. This is now something down to 28 days of age. This is really- anyone can get access to this. Also nice we don’t have to worry about the drug-drug interactions. We’re actually using this- people who are even on dialysis, we’re not particularly concerned about renal function as well. The trick is getting the logistics set up. I’ll say the day this came out, I immediately reached out to Stefan Muehlbauer over at St. Francis Hospital and his response was, “Well, if this is now licensed, we will make sure that we can start providing it, so start sending the kids our way.”

What do you do if you’re not within 15 minutes of St. Francis Hospital and Stefan Muehlbauer? I’m not sure, but no, we’ve got to make sure that– Think about it, if you have a child who’s high risk, they’re under 12, this is the option that can make a difference, so we’ve got to make sure that we take on those operational challenges. Number Three, monoclonal therapy. Right now that’s bebtelovimab, but remember this is only down to 12 years of age, only down to folks weighing 40 kilograms or more, so this is not something we can be looking at in the pediatric population. Remember this has moved down to Number Three.

Number Four, Thor’s hammer, molnupiravir, last option, about 30% reduction in progression. Less impressive, but no renal issues, no drug-drug interactions, but be careful in those women of childbearing age. I want that negative pregnancy test, and this is not authorized in children under 18. Even a little bit more, you got to be over 18 for this medication. All right, the early inflammatory phase, steroids at the right time. This is that individual who starts to get hypoxic. The oxygen level drops below 94. Not everyone goes into the early inflammatory or the severe COVID stage.

Most people don’t, but should they fall through the cracks, and that’s what I’ve been describing this, 90% reduction in ending up here with vaccinations. Another are 80% reduction if we get Evusheld to those high-risk folks, another 87-to-90% reduction if we get early treatment in these folks, but sometimes we miss every opportunity. Here we are, steroids, maybe we’re considering tocilizumab, we’re talking about anticoagulation, right dose, right patient, but more news about sabizabulin, and Vincent there’s no T, I thought there was a T, so apparently it rhymes with Zelensky, but not with–

VR: [laughs] Very good. I love it.

DG: We previously discussed a phase three trial with a 55% reduction in deaths in hospitalized patients, but now we heard, there was a phase two data that was presented at the 32nd European Congress of Clinical Microbiology and Infectious Diseases, Lisbon Portugal, April 23 to 26, sabizabulin for the treatment of hospitalized severe COVID-19 at high risk for acute respiratory distress syndrome. Here, we just have the abstract and the presentation, but these were the results of a double-blind randomized placebo-controlled phase 2 clinical trial evaluating this oral once a day dosing of sabizabulin.

This is supposed to be interfering with the tubulin and the cytokine production, but they looked at sabizabulin versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk of progression to ARDS, acute respiratory stress syndrome, conducted at five sites across the United States. Patients hospitalized with documented evidence of COVID-19, subjects received either the sabizabulin or placebo. Then you could give them steroids, anticoagulants- whatever else you wanted to do.

Respiratory failure, that would the primary endpoint, was the proportion of patients alive without respiratory failure at day 29, and respiratory failure was defined as endotracheal intubation, mechanical ventilation, extracorporeal membrane oxygenation, so ECMO, high flow nasal cannula oxygen, noninvasive positive pressure, it was a lot here. [chuckles] What did we find out in this cohort of patients? Sabizabulin treatment resulted in 82% relative reduction in deaths. Furthermore, sabizabulin resulted in a reduction in mean days in the ICU, 9.6 versus 2.6, so about a seven-day reduction there, about a 73% relative reduction in mean days in the ICU.

Really, I have to say, I’m growing optimism as we keep marching down this road. Now maybe folks who are in the hospital, we can do even more than just steroids and some of the other supportive things we do. All right. The tail phase, COVID is not just a two-week viral illness for many people. “Clinical Characteristics with Inflammation Profiling of Long COVID and Association with a One-year Recovery Following Hospitalization in the UK: A Prospective Observational Study,” was published in The Lancet Respiratory Medicine.

These are the results of the PHOSP-COVID, so the post-hospitalization COVID-19 study which is a prospective longitudinal cohort study recruiting adults, got to be 18 or older, discharged from hospital with COVID-19 across the UK. Recovery was assessed using patient-reported outcome measures, physical performance, organ function at five months and one year after hospital discharge. Actually, I like the introductions in a lot of these publications where they’re really honest and they say that currently there are no evidence-based effective pharmacological or non-pharmacological interventions for patients with Long COVID.

Just sobering that we’re here, but in this group, 2,320 participants were discharged from hospital between March 7th, 2020 and April 18th, 2021. They were assessed at five months after discharge. We have 32.7 participants completing both the five month and one year visits, mean age here, 58.7224, so about 28% ended up receiving mechanical ventilation. The proportion of patients reporting full recovery was unchanged between five months and one year. 25.5% were basically still having issues. What were the factors that were associated?

Female sex, obesity, those who ended up on mechanical ventilation, but a couple other things. And people who are excited about the immunology, they found increased inflammatory mediators of tissue damage and repair including IL-6 concentration. Really actually a hodgepodge of a number of other ones. Hopefully we’re getting a little bit of a better sense here. Let me close on the note that no one is safe until everyone is safe. Right here we are finishing up the last day or two of our American Society of Tropical Medicine and Hygiene fundraiser.

Go to parasiteswithoutborders.com, click the donate button, help us get to our goals so that we can donate potentially up to $40,000 to support the American Society of Tropical Medicine and Hygiene. As part of the support will be scholarships for their annual meeting, travel awards to attend the 2022 meeting in Seattle, Washington, with priority for these scholarships being placed on females from low- and middle-income countries who might not otherwise be able to attend.

VR: Time for some questions for Daniel. You can send yours to daniel@microbe.tv. The first one, Daniel, you have answered, it was from Debbie, an MD who said, “Can you comment on the resurgence of symptoms, and positive tests after testing negative in patients who have taken Paxlovid. What do we know? Who will be studying this?” You’ve answered that.

DG: Oh excellent, that’s right, right on point, good question.

VR: Good question. Katie writes, “I’m a nurse in Austin, Texas. I work at a cardiologist office, recently I spoke with a patient over the age of 65 with coronary artery disease who was asking for a letter of exemption from the COVID vaccine. He stated he gave the cardiologist a letter explaining that his brother had a heart attack after receiving the second vaccine. That is why he did not wish to receive the vaccine, even though he is a believer that vaccines are effective. Included were seven articles, some from Yale. He said, with documentation that this is a proven side effect.

I know of the risk for myocarditis with both virus and vaccine, but I can’t find any articles on this scenario. My question is, if someone is at risk for a heart attack before vaccine, how could it be determined that it was the vaccine that caused it versus other pathophysiology? That doesn’t seem possible but I’m not a physician, or in research.”

DG: This is an excellent thing to bring up, and I think all the way across the board we found that your choice to get vaccinated is much safer than your choice not to get vaccinated. One of the things I think when you look at how many people have died from COVID, still cancer and heart disease are beating COVID in this country. Which is crazy, that 500,000 people are dying every year from cancer, 500,000 people more dying from heart disease. Just think about the odds. You’re an older man, you have coronary artery disease, the coincidence- there will be certain people that have heart attacks before they get vaccinated.

There are certain individuals that have heart attacks after they get vaccinated. What we clearly know, though, is getting COVID without the protection of a vaccine, is associated with a significant increase in your chance of ending up having a heart attack in the next six months. It would be the exact opposite. I would counsel this person that they are much safer being vaccinated than waiting, getting COVID and having that months and months of elevated risk.

VR: Of course you can never figure out if someone got a heart attack the day after the vaccine if it was something else or not, then they’ll never believe you.

DG: That’s the challenge. I think one of the studies, there was a child who swallowed a penny and then they were claiming that maybe penny swallowing was associated with the medication. [laughs] Things happen.

VR: Last one from Brian, “I have a Paxlovid question. Minus renal dosing adjustments and drug interactions, would you have any hesitation about prescribing Paxlovid to someone with liver disease, cirrhosis, NASH, naphthalene based on the listed potential adverse reactions, hepatitis, hepatotoxicity, jaundice. The FDA facts sheet simply says use caution in patients with liver disease, but I’m curious where you would draw the line clinically.”

DG: I guess this will be a testament to how much I’ve been thinking, and reading and involved with Paxlovid recently that I’m going to tell you which subsection of the EUA to look [chuckles] at. It is subsection 5.3, but where they mention the concerns about liver toxicity, it’s actually based upon ritonavir. The thought is that we have seen over the years in the treatment of HIV individuals, we’ve seen issues with ritonavir. The thought is with the five days, with the short dose, we really don’t expect to see much in the way of liver issues.

I would really say it would have to take quite a bit for me to not take a high-risk person. Think about someone who has high-risk because of liver disease, acutely infected with COVID. I’m usually going to feel pretty comfortable going ahead with Paxlovid.

VR: That’s COVID-19 clinical update number 112 with Dr. Daniel Griffin. Thank you, Daniel.

DG: Oh, thank you so much, and everyone, be safe.

[music]

[00:36:18] [END OF AUDIO]

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