Trump: Hydroxychloroquine approved by the FDA for prescription to treat COVID-19 (UP: FDA says it is NOT approved, but currently in testing)

El Pescado

Member
Oct 26, 2017
1,647
My wife takes this for lupus and if it suddenly become hard to get because people are using it inappropriately I’m gonna be so mad. It’s also known to cause blindness in long term use if I’m not mistaken so it’s not “perfect”.
 

NihonTiger

Member
Oct 25, 2017
5,479
My wife takes this for lupus and if it suddenly become hard to get because people are using it inappropriately I’m gonna be so mad. It’s also known to cause blindness in long term use if I’m not mistaken so it’s not “perfect”.
Correct, but that's also why we're still studying it's potential, to see if it is used or has to be used n a way that triggers that effect.
 

Deleted member 9932

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Oct 27, 2017
5,711
I've been taking plaquinel for over a decade. guess I'm immune.
You (and a lot of regular users) might be extremely important right now.

There's definitely someone out there already trying to correlate lupus patients that use this with infected cases. There's probably a lot of data lacking tho, trialing has been anything but great anywhere (outside of korea).
 
Oct 27, 2017
2,165
I'm really hopeful that this has a positive impact and gets us to summer, where hopefully things settle down and our leaders actually use that time to prepare for it's return in the fall.
 

TripaSeca

Member
Oct 27, 2017
2,304
São Paulo
And now the medicine is sold out everywhere and everyone who bought will self-medicate with probable disastrous outcomes, the main one is shortage of medicine to those who really need it... smh
 

AzorAhai

Member
Oct 29, 2017
1,728
My wife takes this for lupus and if it suddenly become hard to get because people are using it inappropriately I’m gonna be so mad. It’s also known to cause blindness in long term use if I’m not mistaken so it’s not “perfect”.
Exactly the same here ! I was surprised at the shortage, I guess I know why now.

Edit: Indeed, these few testimonies are anecdotal but may be relevant. I'm not sure there are appropriate ways to use them though beyond bringing some hope.
 
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SushiX

Member
Oct 25, 2017
766
You need a prescription to get it lol. So how is it sold out everywhere?
Patients pressure doctors to prescribe it or doctors knowingly going off label. A small amount of extra demand will rapidly deplete a pharmacy (pharmacy's keep enough supply for a day or two of typical demand and make orders each night to repelenish supply). The suppliers and drug manufacturer's are used to producing a specific amount for a specific demand, so even small surges in demand locally could produce large shortages at the national and international level.
 

TreadTalks

Avenger
Oct 28, 2017
3,258
United States
If I had a loved one who was ill with COVID19, I would ask the doctor to prescribe the same drugs in the French study off-label and/or remdesivir which is being used on compassionate grounds.

Not gonna sit around waiting for the FDA to take several months or however they normally work just to conduct a first wave study.
Apparently FDA has approved it now for compassionate use (according to ABC news).
 

SushiX

Member
Oct 25, 2017
766
You are painting a grim picture over a medicine that's been safe to use for over 50 years. And as far as I am aware, doctors are approved to apply therapeutics by discretion, like intubation and sedation or drugs with confirmed and logical potential.
I hope the med gets fast tracked in approval for use. It's a generic well-studied drug so I'm not aware of any downsides to using it.
All drug's carry a risk. There needs to be a demonstrated benefit such that the potential positive outweigh the potential negatives. It would be irresponsible to just start handing this stuff out like candy.
 

Speevy

Member
Oct 26, 2017
13,118
All drug's carry a risk. There needs to be a demonstrated benefit such that the potential positive outweigh the potential negatives. It would be irresponsible to just start handing this stuff out like candy.
There won't be sick people to hand it out to if we don't do it soon.
 

carlsojo

Member
Oct 28, 2017
16,353
San Francisco
All drug's carry a risk. There needs to be a demonstrated benefit such that the potential positive outweigh the potential negatives. It would be irresponsible to just start handing this stuff out like candy.
Withholding a medication that may save their life when the medication itself is well-studied and has few side effects could also be argued as irresponsible.
 

Speevy

Member
Oct 26, 2017
13,118
There are going to be plenty of sick people for quite some time to come.
What I mean is, this virus takes 2 weeks to either let your average healthy person recover, or kill an at-risk person, or possibly even kill an unlucky healthy person.

I wouldn't want to be the person who spent a moment debating whether we should do something like this. Even if it fails, there will be other drugs. But there won't be other moms and dads and grandparents.
 

SushiX

Member
Oct 25, 2017
766
There won't be sick people to hand it out to if we don't do it soon.
If you've completed a study demonstrating its efficacy, please submit it and enlighten the rest of us. Otherwise, you're assuming it will help people and that its positives outweigh the negatives. Without further study, we don't know. This could be a useful medication for all COV-19 patients, some patients, or no patients. It could be harmful to all, some, or none. And the degree of benefit or harm may vary as well.

Withholding a medication that may save their life when the medication itself is well-studied and has few side effects could also be argued as irresponsible.
Is that your experience as someone who regularly prescribes this medication and/or manages patients who take this medication? This isn't a rhetorical question and I'm not being sassy; if you're an expert in this field, I'd like to know.

edit: https://www.reddit.com/r/medicine/comments/fbfj0r/covid19_prophylaxis_in_healthcare_workers/

I am involved in planning our regional response for COVID-19. I would appreciate feedback on the reasoning outlined below. I have convinced myself that it makes sense, but am looking for independent feedback and have been struggling to get it.

I would greatly appreciate it if someone could knit-pick this with a fine tooth comb and try and find some mistake I've made (off by a order of magnitude?, etc.), or provide argument why this is a dumb idea.

Edit: more evidence of safety of the once weekly dosing of CQ

Also, I am open to changing the loading dose to that mentioned by commenters to 500mg of CQ at 0- and 6-hours.

Outbreaks of human coronavirus infections have often been centered around hospitals and health-care providers in their early stages. This was seen with SARS-CoV-1 in 2003-04,[1], [2] MERS-CoV in 2018-19[3], and SARS-Cov-2 in 2020.[4] It is presumably related to the non-specific symptoms of these illnesses early in their clinical course coupled with close contact of health-care providers with infected patients in hospital, and inadequate personal protective equipment use.[3]

Infection of health-care providers with highly morbid human coronaviruses is problematic not just due to their subsequent role in propagating infection among vulnerable inpatients, but due to the impact of illness in health-care workers on adequate staffing during an epidemic. This would be expected to be even more pronounced during an outbreak of SARS-CoV-2, given the potential for asymptomatic spread of disease.[5]

As a result, available pre- and post-exposure prophylaxis of health-care workers for SARS-Cov-2 would be ideal. An effective agent would be expected to both prevent spread of disease in hospitals, and maximize the workforce available to provide patient care during an epidemic situation.

To date, there are no known effective treatments for COVID-19, though a number of clinical trials are currently ongoing. The antimalarial chloroquine (CQ) has shown early promise among these. Preliminary results suggest the CQ is superior to control for shortening disease severity, inhibiting exacerbation of pneumonia, improving imaging findings, and improving virus-negative conversion.[6] No significant adverse events were noted in this cohort. As a result, treatment of COVID-19 with CQ has been recommended for inclusion in Chinese national clinical practice guidelines. While CQ has been used to treat malaria and rheumatological diseases for decades, it’s mechanism of action is complex and not fully understood. Due to its basic pKa, CQ preferentially accumulates within cellular lysosomes, subsequently causing lysosomal pH to increase, altering lysosomal function. This has a large number of downstream cellular effects.[7]

In SARS-CoV-1 infection, viral infection is mediated by viral Spike glycoprotein binding to the membrane-bound exopeptidase, Angiotensin Converting Enzyme 2 (ACE2), which is expressed at high levels in Type II Alveolar Cells in the lungs. This binding allows the virus to be phagocytosed into cellular endosomes, with subsequent viral entry into the cytoplasm being dependent on an acidic endosomal pH.[8] Specifically, membrane-fusion is dependent on cellular proteases such as cathepsin B and L splitting viral S-protein into S1 and S2 subunits, with the resulting S2 subunit mediating membrane fusion. Cathepsin B and L activity are inhibited by an elevated endosomal pH.

In vitro studies of SARS-Cov-1 infection in a primate cell line showed that CQ was an effective pre- and post-infective antiviral agent.[9] Specifically, CQ-induced altered ACE2 glycosylation was felt to be the mechanism by which pretreatment prevented infection (by inhibiting S-protein binding and subsquent phagocytosis), and CQ-induced increased endosomal pH (and resulting inhibited protease activity) was felt to be the mechanism by which treatment of existing infection had an antiviral effect.

SARS-Cov-2 infection has been shown to be mediated by the same pathophysiological process as SARS-Cov-1.[10] Recent studies of CQ in vitro with SARS-CoV-2 infection of primate cell lines confirmed the same pre- and post-infective antiviral properties were present as with SARS-CoV-1.[11] Specifically, the EC90 was found to be 6.9uM, and the EC50 was 1.13uM.

Serum concentrations of CQ can be found in this range in patients on CQ for other therapeutic indications. Patients taking 500mg/d of CQ salt (8.3mg/kg/d) were found to have a serum concentration of CQ of 10uM.[12] Unfortunately, patients taking this high of dose of CQ for prolonged periods of time are at risk of developing retinopathy – the maximum daily dose of CQ recommended by guidelines from the American Academy of Ophthalmology are 2.3mg/kg/d based on actual body weight.[13]

Fortunately, CQ has an extremely high volume of distribution. As a result of this, tissue concentrations are significantly higher than serum levels. In the lung, the target organ of SARS-CoV-2 infection, concentrations of CQ are 200-1200x serum values.[14] This would suggest that a steady-state serum concentration of CQ much lower than the EC90 of SARS-CoV-2 would be associated with a target tissue concentration above the EC90. The steady-state serum concentration of 500mg of CQ taken once weekly is 0.1uM,[12] which given the above reasoning, would be expected to lead to a lung concentration above the reported EC90 of SARS-CoV-2. 500mg of CQ taken once weekly is the malaria prophylaxis dose of CQ. This dose is extremely well-tolerated with minimal side-effects in most patients, and well below the threshold dose known to be associated with an increased risk of retinopathy.

Given that the duration of pre-exposure prophylaxis could be on the order of months, the use of a dose well below the threshold associated with an increased risk of retinopathy is preferred. If exposure to SARS-CoV-2 cases is relatively infrequent, then a short course (say, the duration of the potential incubation period of infection) of a higher dose could be used a form of post-exposure prophylaxis, allowing maximal tissue concentrations in the days after exposure, while minimizing possible side-effects. In healthcare providers providing daily care to patients with confirmed SARS-CoV-2 infection for a prolonged period of time, this higher dose could still be taken regularly with minimal risk of side-effects, provided the total treatment duration was less than a year.

CQ also has an extremely long half-life, in the order of 3-5 days. This unfortunately means that therapeutic steady state concentrations are not reached until after weeks of therapeutic dosing, unless a loading dose is received.[12] When CQ is used to treat acute malaria, a loading regimen of 1000mg at 0h, 24h, and then 500mg at 48h is used as a result. This dosage schedule has been shown to rapidly increase serum levels in humans, with a serum concentration greater than 1uM achieved continuously within hours of the first dose.[15] The implication of this is that if CQ was used for post-exposure prophylaxis, a loading dose would be required. Given the rapidly changing environment of an epidemic, waiting several weeks to achieve a therapeutic steady state concentration may also be impractical, suggesting utility in using a loading dose even for pre-exposure prophylaxis dosing.

Based on the above reasoning, I would suggest the following dosing regimens of CQ if used prophylactically in healthcare workers to prevent SARS-CoV-2 infection:

Pre-exposure prophylaxis: Loading dose: 1000mg of chloroquine salt (600mg base) taken at 0-hours, 24-hours, and then the first 500mg dose (300mg base) taken at 48-hours. Ongoing treatment: 500mg chloroquine salt (300mg base) taken once weekly.

Post-exposure prophylaxis: Loading dose: 1000mg of chloroquine salt (600mg base) taken at 0-hours, 24-hours, and then 500mg of chloroquine salt (300mg base) at 48-hours. Ongoing treatment: 500mg chloroquine salt (300mg base) taken daily for 12 days.'

  • Edit: it has been suggested below by u/Pandalite to replace the loading dose regimens describe above with: 500mg of CQ salt at 0-hr, then 6-hour. Though I don't have pharmacokinetic data I've found yet to support that it will lead to target levels, I would expect that it would.*
Hydroxychloroquine (HCQ) is nearly identical in structure to CQ and has a similar mechanism of action and therapeutic efficacy in rheumatological and infectious diseases. Like CQ, it also has a long half-life, and a very high volume of distribution. It is similarly concentrated in the lung, with tissue levels 2 orders of magnitude higher than serum levels at steady-state.[14] Kinetic studies of once weekly dosing show a nadir serum concentration of approximately 0.1uM.[16] However, the risk of retinopathy is somewhat lower with HCQ, with retinal toxicity only occurring at doses greater than 5mg/kg/day real body weight for several years. HCQ is also more readily available in some countries than CQ. While it would seem that HCQ should be as efficacious as CQ in preventing and treating SARS-CoV-2 infection, there are no data yet to support this, though a clinical trial using HCQ to treat COVID-19 is currently underway in China.[6] Were HCQ to be used for SARS-CoV-2 prophylaxis in health-care workers, the following dosing would seem reasonable:

Pre-exposure prophylaxis: Loading dose: 800mg of hydroxychloroquine salt (620mg base) taken at 0-hours, then 400mg (310mg base) taken at 6-hours, 24-hours, and 48-hours. Ongoing treatment: 400mg hydroxychloroquine salt (310mg base) taken once weekly.

Post-exposure prophylaxis: Loading dose: 800mg of hydroxychloroquine salt (620mg base) taken at 0-hours, then 400mg (310mg base) taken at 6-hours, 24-hours, and 48-hours. Ongoing treatment: 400mg hydroxychloroquine salt (310mg base) taken daily for 12 days.

It should be noted that the above reasoning is based solely on biological plausibility, which is an extremely low-level of evidence. Ideally, the suggestions made above would be verified clinically before usage. However, the expected minimal harm with the above dosing regimens, coupled with potential benefits in an epidemic situation, could support prophylactic usage in health-care providers even before clinical studies are performed.
 
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Kernel

Member
Oct 25, 2017
13,647
My wife takes this for lupus and if it suddenly become hard to get because people are using it inappropriately I’m gonna be so mad. It’s also known to cause blindness in long term use if I’m not mistaken so it’s not “perfect”.
My wife briefly took it for rheumatoid arthritis but she's allergic to it.

If this ends up being the most promising treatment, there's a good chance I'll become a widower if catches COVID-19.

I hope people aren't dumb enough to take this without medical supervision.
 

carlsojo

Member
Oct 28, 2017
16,353
San Francisco
If you've completed a study demonstrating its efficacy, please submit it and enlighten the rest of us. Otherwise, you're assuming it will help people and that its positives outweigh the negatives. Without further study, we don't know. This could be a useful medication for all COV-19 patients, some patients, or no patients. It could be harmful to all, some, or none. And the degree of benefit or harm may vary as well.


Is that your experience as someone who regularly prescribes this medication and/or manages patients who take this medication? This isn't a rhetorical question and I'm not being sassy; if you're an expert in this field, I'd like to know.

edit: https://www.reddit.com/r/medicine/comments/fbfj0r/covid19_prophylaxis_in_healthcare_workers/
I'm an outpatient cardiology nurse. Not an expert by any means, but if I have to go to the ICU to take care of these patients I would definitely want to do so with a prophylactic prescription.
 

UltraMagnus

Member
Oct 27, 2017
12,209
I'm an outpatient cardiology nurse. Not an expert by any means, but if I have to go to the ICU to take care of these patients I would definitely want to do so with a prophylactic prescription.
Yeah I can't blame any medical staff for feeling that way. You're asking these people to be around COVID patients all day, it's fair for them to ask for hydroxcholorquine as a preventative measure.
 

Deleted member 13628

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Oct 27, 2017
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Withholding a medication that may save their life when the medication itself is well-studied and has few side effects could also be argued as irresponsible.
Different scenario. If someone is in the ICU on a vent and continuing to decline, then sure. You can offer all kinds of experimental therapies. Because there really is nothing to lose. Happens all the time.

As a general treatment for anyone who tests positive for COVID19? That's what further studies are needed for.
If you've completed a study demonstrating its efficacy, please submit it and enlighten the rest of us. Otherwise, you're assuming it will help people and that its positives outweigh the negatives. Without further study, we don't know. This could be a useful medication for all COV-19 patients, some patients, or no patients. It could be harmful to all, some, or none. And the degree of benefit or harm may vary as well.


Is that your experience as someone who regularly prescribes this medication and/or manages patients who take this medication? This isn't a rhetorical question and I'm not being sassy; if you're an expert in this field, I'd like to know.

edit: https://www.reddit.com/r/medicine/comments/fbfj0r/covid19_prophylaxis_in_healthcare_workers/
The medicine is very safe. It's only real side effect is retinopathy. Which happens in a small percentage after years of chronic use. Even then I've never seen it in any of my Rheum patients. Patients on hydroxychloroquine are supposed to get periodic eye exams to assess if retinopathy is developing.

That reddit link is interesting. I've been thinking myself that any pre or post ppx is going to be needed for health care workers. I'm convinced I'm going to get the virus eventually with how often I'm in the hospital treating patients. Hopefully plaquenil works.
 

UltraMagnus

Member
Oct 27, 2017
12,209
Different scenario. If someone is in the ICU on a vent and continuing to decline, then sure. You can offer all kinds of experimental therapies. Because there really is nothing to lose. Happens all the time.

As a general treatment for anyone who tests positive for COVID19? That's what further studies are needed for.


The medicine is very safe. It's only real side effect is retinopathy. Which happens in a small percentage after years of chronic use. Even then I've never seen it in any of my Rheum patients. Patients on hydroxychloroquine are supposed to get periodic eye exams to assess if retinopathy is developing.

That reddit link is interesting. I've been thinking myself that any pre or post ppx is going to be needed for health care workers. I'm convinced I'm going to get the virus eventually with how often I'm in the hospital treating patients. Hopefully plaquenil works.
If you're an elderly patient that tests positive for COVID19, I think it should be prescribed if further efficacy is shown.

Not only for their own sake, but ICU beds, ventilators, hospital staff are not a luxury anymore. It is vital to keep people out of the ICU in the first place by whatever reasonable means are available.

You would need to take like several years worth of regular hydroxychlorquine doses for eye issues to become a problem. Don't think that's going to apply to a week's dosage.


One often cited side effect is chloroquine retinopathy, which can result in permanent vision loss after high cumulative doses of chloroquine. However, retinal damage is extremely rare in patients with a total dosage under 400g (dosage level only reached after years of treatment).
 

NTGYK

Attempted to circumvent ban with an alt-account
Banned
Oct 29, 2017
3,471
China has been using it for a month or so.


The SARS-CoV-2 (the actual designated name for this virus) Wiki is actually pretty cool. It's like a live update of everything you need to know.

Honestly, I don't understand why we just don't call it SARS2: Revengence.
We leave names like that to history.
 

KDR_11k

Member
Nov 10, 2017
4,633
So will Far Cry 6 bring back the malaria mechanic except your character has COVID-19 instead?

Speaking of names, why isn't it CORVID-19?
 

Zyrokai

Member
Nov 1, 2017
2,463
Columbus, Ohio
Is there a good summary of what's going on? The OP talks about Hydroxychloroquine but now we're talking about Plaquinel? Just a little confused.
 

Ayato_Kanzaki

Member
Nov 22, 2017
1,126
I wouldn't want to be the person who spent a moment debating whether we should do something like this. Even if it fails, there will be other drugs. But there won't be other moms and dads and grandparents.
I understand what you mean, but making public a cure that doesn't work in the end has another consequence: people will stop worrying about the virus if they think it's just a matter of swallowing a few pills, and won't take precautions anymore, which will propagate the virus faster.

That's why Trump's anoucement is criminally irresponsible. It's going to increase casualities, and he does it only to downplay a crisis he contributed to. Hell, I wouldn't be surprised if he bought stocks from the laboratories producing those pills just before running with this.
 

RedSonja

Member
Oct 29, 2017
842
Good old hydroxychloroquine. If you've got an autoimmune rheumatological condition, you may have met this fellow before. This drug has quite a nice CV.
 

iyox

Member
Oct 25, 2017
309
I understand what you mean, but making public a cure that doesn't work in the end has another consequence: people will stop worrying about the virus if they think it's just a matter of swallowing a few pills, and won't take precautions anymore, which will propagate the virus faster.

That's why Trump's anoucement is criminally irresponsible. It's going to increase casualities, and he does it only to downplay a crisis he contributed to. Hell, I wouldn't be surprised if he bought stocks from the laboratories producing those pills just before running with this.
The discussion around this drug and the general response to the virus in the west is really infuriating. I will preface the rest of my post by simply saying I hope this(and other potential remedies) pan out and can save lives.

I do not understand why people can not focus on the pieces that have proven effective, mainly testing. Furthermore, the lack of testing caused this breakout. I was aware of and in communication with people from work who were quarantined on Seattle on February 3rd. Guess what never happened to them? Never tested. They had no symptoms and simply went out into the public after the quarantine period was over. Were they infected? Who knows at this point.

The discussion around this drug reflects the sad reality we are currently in, the US administration has turned to a legacy pharmaceutical hoping for a miracle. We need one and I hope it is, doesn’t mean it’s not upsetting
 

SushiX

Member
Oct 25, 2017
766
I'm an outpatient cardiology nurse. Not an expert by any means, but if I have to go to the ICU to take care of these patients I would definitely want to do so with a prophylactic prescription.
Yeah, after looking into this a bit more, I realize my initial reaction was a bit too reflexive. The only side effect I could remember was the increased retinopathy which required an eye check before going on it and 5 years thereafter and I assumed there were more risks than that. I should've done a bit more reading before jumping into the discussion.

Different scenario. If someone is in the ICU on a vent and continuing to decline, then sure. You can offer all kinds of experimental therapies. Because there really is nothing to lose. Happens all the time.

As a general treatment for anyone who tests positive for COVID19? That's what further studies are needed for.


The medicine is very safe. It's only real side effect is retinopathy. Which happens in a small percentage after years of chronic use. Even then I've never seen it in any of my Rheum patients. Patients on hydroxychloroquine are supposed to get periodic eye exams to assess if retinopathy is developing.

That reddit link is interesting. I've been thinking myself that any pre or post ppx is going to be needed for health care workers. I'm convinced I'm going to get the virus eventually with how often I'm in the hospital treating patients. Hopefully plaquenil works.
I'm glad you found it interesting. I've edited my post to include that reddit post in its entirety if you'd like to refer back to it later since I suspect that reddit post may be removed at some point.
 
Oct 25, 2017
167
So there’s basically a zero percent chance that he and/or his immediate family members didn’t buy stock in the company that makes this medicine, right?

He doesn’t go off script like this for no reason. Always looking for his next grift.