Pogue : Right, the title of the manuscript is hydroxychloroquine plus azithromycin. I think this is where a lot of the debate and where a lot of the interest comes from. So again, remember we're starting to talk about small subsets of patients when we do this, but in their analysis, there were 6 patients that received azithromycin.
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They described that for either treatment or for prophylaxis of bacterial infection. There was just a subgroup of hydroxychloroquine patients that also got azithromycin in combination, there was actually only 6 patients. So you can see why a lot of excitement came from that. In addition to that, there's a really nice figure in the manuscript. I think this is what really got people interested.
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Because they were getting daily swabs on these patients, they looked at eradication rates on day 1, 2, 3, and so on and so forth. What you can really see is that around day 3, we really start to see this apparent demarcation between monotherapy with hydroxychloroquine and then the combination from that standpoint. So, if these data hold true, and if these data are accurate, that's a huge implication, right?
You're eradicating virus. So a couple things with that.
Hydroxychloroquine and Chloroquine
One, hopefully the patients will improve, although they did not look at clinical outcomes in this study. But in addition to that, I think it's important that there's potentially a bigger impact on the global spread of this. There's a lot of potential things that could be there, so that's why on the surface, that becomes a really important finding in this study.
Pogue: Yeah, so simply put, my answer would be no. But I think that I have to elaborate on that a little bit. Although these data look good on the surface, I think there are a number of limitations to this data set that we need to talk about. Again, we have to be able to critically assess these data as they come out. The first thing that I would comment on is this. Remember I said at the beginning that there were 20 patients in the hydroxychloroquine group, and 16 patients who got standard of care. But, if you actually look at the methods in the study, you'll see that there were actually 26 patients who got hydroxychloroquine.
For this analysis, remember, the primary thing was eradication at day 6. In order to be assessable, they still have to be analyzable at day 6. There were actually 6 patients in the hydroxychloroquine group that dropped out of the study because they were no longer assessable. I think it's important for viewers to note that if you actually look in the methods, these 6 patients, there were 3 of them that were taken out of the study because they decompensated and went to the ICU.
Every single one of those patients was still PCR positive. There was 1 patient that passed away, that was actually PCR negative, but passed away. There was 1 that went home who was actually PCR negative. Then 1 actually stopped due to nausea—a side effect from the hydroxychloroquine—who was still PCR positive as well. In my opinion—although I understand why the authors did what they did—at least 5 of these patients, I would consider failures.
You have patients go into the ICU, you have a patient that passes away, you have someone who had to stop due to an adverse event. If you think about the impact that could have It still might be a significant difference, and I ran the numbers, it still is a pretty nice difference. But I think it's important to note that that's 1 piece of the story.
New York State will start coronavirus drug trials
That's 1 really important thing. The second one, though, in my opinion, is much more important. That's really getting down to the azithromycin finding. This is what's gotten people really interested and excited. First and foremost, if you look there's a really nice table.
One thing that I really like about the publication is there's they really put the data out there for us to look at. So right now, we're no longer comparing to the control group, we're talking about the comparison between patients who got hydroxychloroquine monotherapy, and those who got that combination. If you look at that, the first thing that jumps out is that there are some virological differences between the 2 groups. Let me explain what I mean by that. I won't get into numbers and cycle thresholds or anything like that, because it's not going to add a whole lot to this conversation.
But bottom line, what you'll find is that there's a subset of patients in the hydroxychloroquine monotherapy group that had higher viral loads. Okay, so just logically, those patients would require more out of a drug therapy to be able to eradicate the organism in that situation. So when I look at these data, and we assess these data, if you take out those patients who have higher viral loads, and you try to make the monotherapy and combination therapy more on even terms, what you'll find is that the differences between the 2 completely go away.
Hydroxychloroquine monotherapy does really well in that situation. You'll see very similar eradication rates at day 6. But, remember that we talked about before that we were looking at that time to clearance on day 2, on day 3, and day 4 and so on and so forth. You'll see that they pretty much over overlap. I think there's a huge limitation that the benefit of combo over mono might just be driven by differences between the patient population.
When you get rid of that, when you kind of limit it to like patients, at least from a biological standpoint, the difference goes away. So I think that viewers need to think about that and read and critically think through that process. When you see that type of a finding, then you have to kind of keep walking down that pathway, right? The next one is what I expect azithromycin to help out in this situation? The bottom line is there's no evidence outside of this publication that would suggest that there's going to be some bang out of giving azithromycin to our patients.
There's no clinical data. There's no animal data. When you start to walk through that process, in my opinion, it gets really hard to get to a logical place that azithromycin is playing a role here. Especially when you limit the study to like patients, there's absolutely no difference between the 2 groups. If you kind of keep walking that story through, [there's] not a real likelihood of benefit, and then you have to think is there a risk if I give my patient both of these therapies in combination? And I would argue that there absolutely is.
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Howard Zucker feels comfortable, as well as a number of other health professionals, that in a situation where a person is in dire circumstance, try what you can. A limited study in France found that the combination of azithromycin and hydroxychloroquine could be effective in treating patients with the coronavirus. But Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, cautioned that the study wasn't a controlled trial.
Trump tweeted Saturday that the drugs could be "one of the biggest game-changers in the history of medicine. The side effects include vision problems, irregular heartbeat and sudden death. New York will play a role in determining whether the combination of the antibiotic and anti-malaria drugs can be effective in treating the coronavirus. The drug trials will be part of other New York efforts to identify treatments and vaccines for the coronavirus.
Cuomo said researchers are working on a possible antibody therapy and vaccines. The Food and Drug Administration will send , doses of chloroquine, 75, doses of hydroxychloroquine and 10, doses of Zithromax. Politics reporter Robert Harding can be reached at or robert. Follow him on Twitter robertharding. Sign up now to get the most recent coronavirus headlines and other important local and national news sent to your email inbox daily. I have been The Citizen's online producer and politics reporter since December With more than 10, confirmed cases of the novel coronavirus in New York, Gov.
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