Pfizer's Paxlovid Fails As A Prophylactic Therapy for COVID-19
In a disappointment for Pfizer, Paxlovid failed to protect the household members of COVID positive patients.
My video on this topic
Cliff notes for my talk about this topic on May 10th 2022. Once the lecture is done, then I will add that link here as well.
Summary:
COVID-19 Therapy:
Paxlovid is a combination of two antiviral drugs. Nirmatrelvir and Ritonavir.
EPIC-HR trial: Paxlovid is associated with 89% lower risk of progression to severe COVID-19 disease.
EUA for COVID-19 (confirmed positive) patients that are at-risk of progressing to severe disease or death and are 12+ years of age and weigh at least 40kg.
Prophylaxis: Pfizer conducted another trial called EPIC-PEP that started recruiting in September 2021. Trial was for the prevention of COVID-19 in household members of COVID-19 patients.
Paxlovid was started from day 1 for 5 or 10 days.
Primary end-point was to reduce the risk of confirmed and symptomatic COVID-19 in adults who were exposed to a confirmed COVID-19 positive patient.
Paxlovid failed to show any statistically significant positive result.
The 5 days group had a chance occurrence of 32% efficacy and the 10 days group had a chance occurrence of 37% efficacy.
Details:
2,957 persons participated. These persons had exposure within past 96 hours to a COVID-19 positive patients.
Participants had to be asymptomatic and PCR negative.
Each patient was randomized to receive either Paxlovid for 5 days followed by placebo for 5 days, or Paxlovid for 10 days, or placebo for 10 days.
Again, Paxlovid failed to show a statistically significant protection.
Viral rebound: In the trial and now in production there are incidences of the viral load increase (rebound) after the management with Paxlovid. Company says this happened in placebo receiving patients as well, hence, they are confident that Paxlovid is amazing (paraphrasing.)
Competition (Molnupiravir): Interestingly Molnupiravir has shown disappointing efficacy against severe COVID and deaths.
How does Paxlovid work? Here’s my video on this.
References
DrBeen: Medical Education Online
https://www.drbeen.com/
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 - Full Text View - ClinicalTrials.gov
https://clinicaltrials.gov/ct2/show/NCT04960202
Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19 | NEJM
https://www.nejm.org/doi/full/10.1056/NEJMoa2118542
Clinical Studies | PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)
https://www.covid19oralrx-hcp.com/clinical-studies?source=google&HBX_PK=s_paxlovid+results&skwid=43700068281649038&gclid=Cj0KCQjwmuiTBhDoARIsAPiv6L_CQ8C5C7AQsXGYtMhZx5rjk7W8pNjd3gdK_Z1BYWY8X7Ifv_-iu5UaAm6-EALw_wcB&gclsrc=aw.ds
Paxlovid HCP FS 04142022
https://www.fda.gov/media/155050/download
EUA 105 Pfizer Paxlovid DHCP 04142022
https://www.fda.gov/media/155071/download
Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use | Pfizer
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-top-line-results-phase-23-epic-pep-study
Paxlovid Mouth Is Real—And Gross - The Atlantic
https://www.theatlantic.com/health/archive/2022/05/pfizer-paxlovid-covid-pill-side-effects/629772/
Pfizer says COVID treatment Paxlovid fails to prevent infection of household members | Reuters
https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-says-covid-treatment-paxlovid-fails-prevent-infection-household-members-2022-04-29/
FDA warns Paxlovid as COVID treatment option
https://www.fiercepharma.com/pharma/fda-rebukes-pfizers-suggestion-take-more-paxlovid-if-covid-19-symptoms-return
Covid-19 cases that return after Paxlovid antiviral treatment puzzle doctors - CNN
https://www.cnn.com/2022/04/27/health/paxlovid-covid-rebound/index.html
FDA EUA Note for Paxlovid
https://www.fda.gov/media/155194/download
In other words, as a prophylaxis, Paxlovid is just as good as a placebo.
Today is the international CFS/M.E awareness day. Long-covids older and uglier step sister. Something I am intimately familiar with. Something otherwise not spoken of.
Here is my poem.
THE WAR WITHIN
I used to be a soldier and so proud I was to serve. Active strong and healthy, with an impressive and steady nerve.
I always aspired to take a step and go further than the rest. Beyond fatigue, aches and pains, to be the very best.
As a younger man I dreamed big and was proactive when I played. Hoping in my older years my dedication paid.
And then one somber month alone I began to feel unwell. But the warrior inside of me would never ever tell.
So I fought and fought the hardest battle I would ever have to fight. But this battle was different and could not be beat by might.
The more I fought the more I tired and down and down I went. Even then I fought some more until all I had was spent.
That month turned to two, then three and four to five. Until I was too tired to fight anymore, I barely felt alive.
It doesn't matter how tought you are, M.E. don't give a damn. The harder you try to fight it, the more it'll drag you down.
Life has changed a lot these days, my dreams no longer bold. No more aspirations to scale mountains in search of Aztec gold.
Holding down a part time job it seems is challenging enough. ‘cause M.E. is my full time now and the pay is kind of rough.
So struggling financially with a massive loss of pride. If only there was a way off of this retched hellbent ride.
Some confidence, pride and security, just to walk the local hills. To eat a spicy curry, to enjoy some simple thrills!
To earn a buck, leave my mark and have some dignity. This is what CFS/M.E awareness has come to mean for me.