Sharing a few threads on whether molnupiravir (new antiviral on the cusp of approval) risks generating new variants because the mutations it induces may, rarely but possibly, not kill the virus but generate viable variants instead. Many on the FDA panel who voted no raised this.https://twitter.com/CT_Bergstrom/status/1467611446053851145 …
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This is Dr. Hildreth on the FDA advisory phrased it after the vote. (He wasn't the only one on the panel to raise the issue).https://twitter.com/JamesEKHildreth/status/1465806607909064705 …
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One question I have is what happen with patience non-compliance? The pill is supposed to be taken over five days, every 12 hours at home (I think 40 pills total). There's going to be a lot of incomplete regimens in this scenario. How does this affect this risk?
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(Also, the trial had two phases and the drug had *zero* efficacy in the second phase which is really weird. It suggests regression to the mean so perhaps there is little to no benefit after all. Seems worth a longer study, but that's a separate question).
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Overall, we have multiple scientists raising the alarm that a new drug may end up generating new variants, many on the FDA panel voting no citing that very concern, and real questions on whether there's any benefit—already on the low side as claimed. Seems worth taking seriously.
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Pfizer antiviral doesn't use the same mechanism, so does not have the same risk. I think antivirals are an excellent addition to our arsenal. That said, so many on the FDA panel raised this issue, and still little news coverage? How do we get more clarity?https://twitter.com/diagionals/status/1467892862092288000 …
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Here's a post by
@Dereklowe on this question, but also highlighting below the part where he wonders (as have others), if the already low reported benefit is there at all? (The trial data is really weird...) https://www.science.org/content/blog-post/rethinking-molnupiravir …pic.twitter.com/tGTd3jcvdb
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I think we can assume that there'll be some patient noncompliance (stopping early, skipping doses, erratic timing) as well as re-targeting (hoarded/left-over pills being shared). How does this affect this tail risk—not to the patient, but to society?https://twitter.com/Dereklowe/status/1467906065882927112 …
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To some asking: This mechanism doesn't apply to vaccines (vaccines aren't drugs—this is a drug specifically mutagenic to the virus), nor to Pfizer's antiviral (which targets enzymes, and is also not mutagenic to the virus). So concerns are only about this (or similar) drugs.
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End of conversation
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