Pfizer finally published its study of Paxlovid’s effects on symptoms for standard-risk and high-risk vaccinated patients with Covid-19. No difference in symptoms. The upshot of the trial, known as EPIC-SR and published in the New England Journal of Medicine
I read the study also: it was from 2021-2022 Delta/Omicron--the patients tended to be younger, median age 46, the only death was in the placebo group. Recently the Gilead antiviral stopped moving ahead for no reduction in illness: based on that criteria, Paxlovid would have been canned. Are we concerned about acute illness or later sequela, hospitalization/death? I think the use of Paxlovid should be for higher risk people to prevent hospitalization and death and while the numbers weren't felt to be significant, there was a 50% reduction in those small numbers (I realize you discussed absolute/relative risk reduction). Paxlovid is not the wonder drug, but they also didn't study outcomes after 28 days. We desperately need drugs with less drug interactions, lower cost and easier access for the highest risk people. The NEJM editorial said that this study showed we need more meds and more studies. 1000 people a week have been still dying even with low viral wastewater trends, we need to target those people. Is there any impetus for more study--after this 2 year old trial?
I am a firm believer in published research. In our COVID formed family pod of ten, after being extremely careful, nine got COVID 18 months ago. We are three grandparents in our 70s, one in his 80s, two adults in their forties, and three kids. One adult brought it back after traveling, and we went down like bowling pins. One kid who had had COVID a year earlier did not get it. All six adults took Paxlovid. (One of the 40s has an immune disorder, the other is a hospital based doc.) As an N of one, I found Paxlovid helpful. My initial symptoms were fever, massive headache, and eye pain. My symptoms disappeared almost immediately after taking Paxlovid. I was the only adult who rebounded, but I'd take it again.
Like Jan, I immediately (within a day) felt better with Paxlovid (a year ago-probably the XBB version or one like it) and was negative by testing on day 7-no rebound-while my husband, slightly immunosuppressed and unable to take it due to drug interactions, took 31 days to clear it, with symptoms the whole time. Both of us well vaccinated and in our 70s. Believe me, I’d take it again without question.
The acute effects of Covid concern me, but it's the potential for long term health consequences that motivates me to keep current on vaccines and still use a respirator. Would love to see an updated study as to how much, if any, Paxlovid actually helps reduce the chance of long Covid with the current circulating variants.
Michael Osterholm addressed the study on his podcast and felt that the lack of older people limited the conclusions: “Can we really say an unvaccinated 18-year-old has the same risk factor as a vaccinated 89-year-old? I don't think so." Osterholm said today in today's episode of the Osterholm Update.
"We need to avoid overgeneralizing the findings to older, high-risk populations," Osterholm said. For those people, Paxlovid is still a useful first-line treatment.”
Seems the headline OUGHT to have been that in this kinda smallish trial group, very few people got seriously ill. YAY!
And the sub-hed should've been that Paxlovid seemed to be associated with less severe illness, tho the size of the study was too small to be definitive, given that overall, enrollees did pretty well regardless.
The authors note their results are not inconsistent with other studies showing that Paxlovid was helpful in reducing progression to severe disease and death. That, too, is not inconsistent with a doctor playing dice with his patients, saying, “you'll probably be fine.” It's true but it doesn't get to the heart of the patient's objective in seeking care that, if delayed, is not available later. If I wanted to play Russian Roulette with a disease known to be sometimes fatal, I don't need a doc to tell me most of the gun's chambers are empty.
Paraphrasing Keynes, these researchers “set themselves too easy a task by saying once the storm has passed, the sea will be calm again.” And, “in the long term, we're all dead.”
I am assuming the trial was using a five day run of Paxlovid. Aren't they currently studying what happens with a ten day prescription? Purely anecdotal but while my husband did have rebound on a five day course a week later he was over Covid and had none of the prolonged symptoms.
You mentioned that Paxlovid may help very high risk patients such as the immunocompromised. Hopefully true, as long as there’s no contraindication to taking the drug. Unfortunately, patients who are immunocompromised on the basis of taking immunosuppressants after organ transplant are likely on tacrolimus, which has a severe Paxlovid interaction. We need an oral “remdesivir-like” antiviral, which is available in China (and elsewhere) but not the U.S.
Drs. Griffin and Racaniello talked about the NEJM Paxlovid study in TWiV's Clinical Update this week-- I was really interested in hearing the Virology perspective.
I read the study also: it was from 2021-2022 Delta/Omicron--the patients tended to be younger, median age 46, the only death was in the placebo group. Recently the Gilead antiviral stopped moving ahead for no reduction in illness: based on that criteria, Paxlovid would have been canned. Are we concerned about acute illness or later sequela, hospitalization/death? I think the use of Paxlovid should be for higher risk people to prevent hospitalization and death and while the numbers weren't felt to be significant, there was a 50% reduction in those small numbers (I realize you discussed absolute/relative risk reduction). Paxlovid is not the wonder drug, but they also didn't study outcomes after 28 days. We desperately need drugs with less drug interactions, lower cost and easier access for the highest risk people. The NEJM editorial said that this study showed we need more meds and more studies. 1000 people a week have been still dying even with low viral wastewater trends, we need to target those people. Is there any impetus for more study--after this 2 year old trial?
I am a firm believer in published research. In our COVID formed family pod of ten, after being extremely careful, nine got COVID 18 months ago. We are three grandparents in our 70s, one in his 80s, two adults in their forties, and three kids. One adult brought it back after traveling, and we went down like bowling pins. One kid who had had COVID a year earlier did not get it. All six adults took Paxlovid. (One of the 40s has an immune disorder, the other is a hospital based doc.) As an N of one, I found Paxlovid helpful. My initial symptoms were fever, massive headache, and eye pain. My symptoms disappeared almost immediately after taking Paxlovid. I was the only adult who rebounded, but I'd take it again.
Like Jan, I immediately (within a day) felt better with Paxlovid (a year ago-probably the XBB version or one like it) and was negative by testing on day 7-no rebound-while my husband, slightly immunosuppressed and unable to take it due to drug interactions, took 31 days to clear it, with symptoms the whole time. Both of us well vaccinated and in our 70s. Believe me, I’d take it again without question.
The acute effects of Covid concern me, but it's the potential for long term health consequences that motivates me to keep current on vaccines and still use a respirator. Would love to see an updated study as to how much, if any, Paxlovid actually helps reduce the chance of long Covid with the current circulating variants.
Michael Osterholm addressed the study on his podcast and felt that the lack of older people limited the conclusions: “Can we really say an unvaccinated 18-year-old has the same risk factor as a vaccinated 89-year-old? I don't think so." Osterholm said today in today's episode of the Osterholm Update.
"We need to avoid overgeneralizing the findings to older, high-risk populations," Osterholm said. For those people, Paxlovid is still a useful first-line treatment.”
Did the look at impact on incidence of long Covid ? Are there other studies looking at that?
Seems the headline OUGHT to have been that in this kinda smallish trial group, very few people got seriously ill. YAY!
And the sub-hed should've been that Paxlovid seemed to be associated with less severe illness, tho the size of the study was too small to be definitive, given that overall, enrollees did pretty well regardless.
The authors note their results are not inconsistent with other studies showing that Paxlovid was helpful in reducing progression to severe disease and death. That, too, is not inconsistent with a doctor playing dice with his patients, saying, “you'll probably be fine.” It's true but it doesn't get to the heart of the patient's objective in seeking care that, if delayed, is not available later. If I wanted to play Russian Roulette with a disease known to be sometimes fatal, I don't need a doc to tell me most of the gun's chambers are empty.
Paraphrasing Keynes, these researchers “set themselves too easy a task by saying once the storm has passed, the sea will be calm again.” And, “in the long term, we're all dead.”
Off topic from Pax, but an update about Mucosal Covid Vaccine development and Project Next Generation:
https://absolutelymaybe.plos.org/2024/03/29/a-huge-boost-for-mucosal-covid-vax-development-next-generation-update-15/
I am assuming the trial was using a five day run of Paxlovid. Aren't they currently studying what happens with a ten day prescription? Purely anecdotal but while my husband did have rebound on a five day course a week later he was over Covid and had none of the prolonged symptoms.
You mentioned that Paxlovid may help very high risk patients such as the immunocompromised. Hopefully true, as long as there’s no contraindication to taking the drug. Unfortunately, patients who are immunocompromised on the basis of taking immunosuppressants after organ transplant are likely on tacrolimus, which has a severe Paxlovid interaction. We need an oral “remdesivir-like” antiviral, which is available in China (and elsewhere) but not the U.S.
Drs. Griffin and Racaniello talked about the NEJM Paxlovid study in TWiV's Clinical Update this week-- I was really interested in hearing the Virology perspective.
If you want to check it out, here's a link to the video. The Paxlovid bit starts roughly around 16:00 : https://youtu.be/v5s2hCh6bsI?si=toh6f8G5ZQ1NVKVi
We've lived long enough for Paxlovid to become Tamiflu. Though Tamiflu doesn't have rebound.