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MarkHoofnagle's profile
Mark Hoofnagle
Mark Hoofnagle
Mark Hoofnagle
@MarkHoofnagle

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Mark Hoofnagle

@MarkHoofnagle

Trauma/Critical Care/Acute Care Surgeon. MD/PhD. FACS. UVa/UMD/UPenn. Asst Professor of Surgery at Wash U. Blocking is curating.

St Louis, MO
surgery.wustl.edu/people/mark-ho…
Joined March 2012

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    Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

    I am truly sorry to say, Remdesivir is probably worthless, and we are seeing some fascinating drug company shenanigans, a thread.

    8:20 AM - 1 May 2020
    • 4,414 Retweets
    • 10,187 Likes
    • The Real Agenda, podcasts for progressive change Sebastian Hantel Rounding the Earth C-19 & Vitamin D GZK 🇸🇦 Ǎ̶̡̢̼̅͠d̶̢̡͎͇͔͓̗͉͊͒͊̾̒͜͠ä̴̩̪̘̳̭̐̆̀͝ḿ̴͙͇͂͌̅̂͆̚͝͠ Rob Barrett Jr. Chad R. Smith
    296 replies 4,414 retweets 10,187 likes
      1. New conversation
      2. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        First, the pretest probability that an infused, small-molecule inhibitor of a virus would improve mortality in symptomatic patients was already pretty low. Unfortunately, antivirals work poorly in acute disease. This has to do with their mechanism@of action, and host response.

        10 replies 103 retweets 770 likes
        Show this thread
      3. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Antivirals usually target some aspect of viral replication/assembly/transmission. Remdesivir is a clever pharmacologic prodrug that inhibits a key piece of RNA viruses that mammals don’t have - the RNA-dependent RNA polymerase, and inhibits viral replication.

        5 replies 93 retweets 608 likes
        Show this thread
      4. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Unfortunately, by the time you are symptomatic with a virus, you are usually already high/peak viral load. So, when you give an antiviral to someone who is already ill, the damage from the virus is largely done. It’s there in big numbers and in the cells.

        17 replies 154 retweets 864 likes
        Show this thread
      5. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Consistent with this, the Lancet paper on the remdesivir trial in China shows no impact on viral load clinically.pic.twitter.com/ITifhKB8w2

        14 replies 221 retweets 925 likes
        Show this thread
      6. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Pick your metaphor. The cat is out of the bag. The damage is done. At this point the host response to virus is activated, and your body is suppressing replication through a variety of mechanisms (which also make you feel terrible).

        12 replies 78 retweets 669 likes
        Show this thread
      7. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        So how could inhibiting RDRP after the fact help? The answer is, it probably doesnt. It certainly didn’t in this trial - no difference, not even a trend in mortality, but in subgroup analysis maybe shortened disease duration in early/mild disease.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext …

        8 replies 119 retweets 651 likes
        Show this thread
      8. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Now, critics of stupid drugs that should never have been stockpiled by govts say, “sounds like Tamiflu!” Yes. This is the same as Tamiflu, which also maybe shortens flu by a day, but otherwise is a largely useless antiviral (and actually harmful with bad side effect profile).

        7 replies 148 retweets 967 likes
        Show this thread
      9. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Fortunately, side effects of remdesivir did not seem severe in this trial with only about 3x as many patients stopping than placebo, some rashes, nothing life threatening.

        5 replies 59 retweets 499 likes
        Show this thread
      10. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Where do the Shenanigans come in? Well, remember how maybe this Chinese trial showed a shortened course in a subset of patients? Like tamiflu? But didn’t change mortality? Well a month ago the NIAID trial changed their endpoints to remove death and instead look at dz duration.

        8 replies 138 retweets 798 likes
        Show this thread
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      12. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        This is like declaring a race and then when you realize you’re not going to win, declaring the destination was actually wherever you are standing at the moment.

        6 replies 124 retweets 1,003 likes
        Show this thread
      13. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Then, even more fishy, *the same day* as this Lancet trial is release, Gilead and NIAID claim a “positive trial” and they’ve “shortened the course of the disease significantly”. Notably, the mortality benefit did not reach significance.

        11 replies 133 retweets 789 likes
        Show this thread
      14. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        By the end of the day, reports that FDA is going to emergently approve remdesivir for treatment of COVID. Gilead gets what they want. No one will want to be in a control arm in further trials and they will argue all future trials must be noninferiority.

        9 replies 135 retweets 747 likes
        Show this thread
      15. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Before we have the answer whether this drug actually changes anyone’s destiny, it’s going to become the gold standard therapy. We will likely now never know if (the unlikely possibility) it changes mortality.

        3 replies 121 retweets 698 likes
        Show this thread
      16. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Absolute genius. You have to salute them. On the day a negative trial of their drug is reported, based on a press release they took over the news cycle, and with some midstream edits to their endpoints their now “positive” trial wins them FDA approval and a halted trial.

        8 replies 221 retweets 956 likes
        Show this thread
      17. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        It’s an infusion, once symptomatic, you need an admission, a test, etc., really even symptoms are probably too late a goal for such a therapy to work. Prophylaxis (like Gilead’s Truvada/PreP would be better - but unworkable in its current form.

        9 replies 73 retweets 532 likes
        Show this thread
      18. Mark Hoofnagle‏ @MarkHoofnagle 1 May 2020

        Either way, a big win for Gilead, but I’m unimpressed with any if the evidence presented so far that this is a game changer.

        67 replies 124 retweets 1,011 likes
        Show this thread
      19. End of conversation

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