....Gov. Andrew Cuomo: (21:10)Also available at CNN:
Questions?
Speaker 1: (21:11)
How is the drug trial of a hydroxychlorine and chlorine going?
Gov. Andrew Cuomo: (21:21)
We’ve allowed usage of the hydroxychloroquine with the Azithromycin packs … pack in hospitals. At their discretion. The federal government is going to increase the supply to New York pharmacies. We had a 14 day limit on how much you could buy because so many people were trying to buy it. If the federal government increases the supply to New York, which they say they’re going to do, then we could lift the 14 day limit. There are a lot of people who are relying on this, who were relying on it, people with lupus, et cetera. The tests in the hospital, they won’t say that they are … there too shorter period of time to get a scientific report. Hospital administrators, doctors want to give, have a significant data set before they give a formal opinion. Anecdotally, you’ll get suggestions that it has been effective, but we don’t have any official data yet from a hospital or a quote unquote, “Study.” Which will take weeks if not months before you get an official study.
Gov. Andrew Cuomo: (22:44)
Is that a fair statement?
Speaker 2: (22:46)
So, promising, but not conclusive, it sounds like.
Gov. Andrew Cuomo: (22:49)
On which?
Speaker 2: (22:50)
On that that type of treatment in hospitals.
Gov. Andrew Cuomo: (22:53)
Yeah. There has been anecdotal evidence that it is promising. That’s why we’re going ahead. Doctors have to prescribe, but there are some people who have preexisting conditions where it doesn’t work or they’re taking medication that’s not consistent with this treatment. But, anecdotally it’s been positive. We’ll have a full test once they have a large enough sample and data set, Jesse. But, anecdotally it’s been positive. And if we get an additional supply we can, which the federal government says they’re going to send, I’m going to mention it to the president actually when I call him this afternoon, with the comfort, I’m going to make a note right now, if they increase the supply, we can lift the 14 day limit ban....MORE
Aired April 6, 2020 - 12:30 ET
And from the In The Pipeline blog at the journal Science:
Hydroxychloroquine Update For April 6
By Derek Lowe 6 April, 2020
There’s a lot of news to catch up on, and to keep things straight I’ll divide the hydroxychloroquine part out into this post, and cover others in the next one. My previous reviews of the clinical data in this area are here.
First up is this study from France. It’s another very small one, and all the usual warnings apply because of that. It’s from a team at the University of Paris and Saint-Louis Hospital there, and they evaluated 11 consecutive patients admitted there with the same course of treatment as the Marseilles group first reported (hydroxychloroquine 600mg/day and azithromycin, 500mg the first day and 250 mg/day thereafter). The mean age of their patients was 58.7 years, and (notably) 8 of the 11 had significant comorbidities (two obese, 5 with various forms of cancer, one with HIV). That’s a tough population, and unfortunately, the HCQ/AZ combination did nothing. One patient died (and two others went on to the ICU) and of the ten remaining, 8 were still positive for the virus by nasal swab on days 5/6 after treatment. One patient had to discontinue therapy on day 4 because of QT prolongation, a known side effect of hydroxychloroquine that can lead to fatal heart arrhythmia.
So while this is a small study and not a perfect match, it provides no evidence to show that the HCQ/AZ combination had any benefit at all. While we’re on the subject of QT prolongation, there’s this preprint from a medical team at NYU that was also treating patients with the same combination of drugs. In 84 patients, they found notable QT prolongation in about 30% of them, and another 11% were to a level (>500 milliseconds) that put them at a high risk for arrhythmia. This group’s mean age was 63, 74% male. No cancer patients in this group, but 65% did have hypertension and 20% were diabetic (which from many reports is actually a reasonable look at the patients most likely to progress to severe disease). The strongest predictor of dangerous QT numbers was the development of renal trouble while on the drug combination.....MORE, and as usual the comments run the gamut from insightful to snarky.
There are a couple of other things that need to be noted. One is that hydroxychloroquine itself actually lowers the activity of the innate immune system; that’s why people take it for lupus and for rheumatoid arthritis. Many people are saying that perhaps it will work best if taken early in the course of infection, but this effect (which is mediated through TLR receptors) should be kept in mind. Another potentially important point is raised in this preprint – which, it has to be said, is not human data but mouse toxicology. But with that in mind, the authors report what looks like a bad interaction in that species between HCQ and metformin. And by “bad”, I mean about 30% mortality. If this translates at all to humans, it could be bad news, because (as mentioned above) diabetics look like a high-risk group and many patients may well have been taking metformin when they present at the hospital. We need more information on this. An investigational drug combination that showed this effect in mice would not move forward in the normal course of things.
Finally, I would like to point out this preprint from a multi-country team (Denmark, Netherlands, UK) which goes back over the original Marseilles report and reanalyzes its statistics. The problems that many noted with that paper show up in detail here, and the lessons that you take from it can vary a great deal depending on the details that were not well reported or characterized:....
