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John Campbell

Paxlovid, evidence base?

Bywebmaster

Feb 1, 2024



Paxlovid, it this an evidence based intervention in May 2022?

Paper FDA EMU was based on

https://www.nejm.org/doi/full/10.1056/NEJMoa2118542

EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients)

1120 patients received nirmatrelvir plus ritonavir

1126 received placebo

Relative risk reduction

Risk of progression to severe Covid-19, 89% lower than the risk with placebo

Absolute risk reduction

https://www.precisionvaccinations.com/what-paxlovids-absolute-and-relative-covid-19-risk-reduction

7% down to 1%

symptomatic, unvaccinated, non hospitalized adults

at high risk for progression to severe coronavirus disease 2019

July 16 and December 9, 2021

If vaccinated people and previously infected people are partly protected

More people would need to be treated to prevent one adverse event

Pfizer press release (5th November 2021)

https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate

our oral antiviral candidate, … has the potential to save patients’ lives,

reduce the severity of COVID-19 infections,

and eliminate up to nine out of ten hospitalizations

Pfizer Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-vitro-efficacy-novel-covid-19-oral-treatment

https://www.yalemedicine.org/news/12-things-to-know-paxlovid-covid-19

https://www.fda.gov/media/155051/download

The results showed in all cases that nirmatrelvir was a potent inhibitor of its target.

PAXLOVID™ for Post-Exposure Prophylactic Use

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-top-line-results-phase-23-epic-pep-study

Evaluated data from 2,957 adults

Pfizer observed risk reductions of 32% (5 day course)

37% reduction (10 day course)

These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met.

FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS
EMERGENCY USE AUTHORIZATION (EUA) OF PAXLOVID FOR CORONAVIRUS DISEASE 2019 (COVID-19)

https://www.fda.gov/media/155051/download

PAXLOVID is not an FDA-approved medicine in the United States.

PAXLOVID is an investigational medicine

Some medicines may interact with PAXLOVID and may cause serious side effects.

If you take too much PAXLOVID, call your healthcare provider or go to the nearest hospital emergency room right away.

Possible side effects of PAXLOVID are:

Allergic Reactions

trouble swallowing or breathing, swelling of the mouth, lips, or face, throat tightness, hoarseness, skin rash

Liver Problems. Tell your healthcare provider right away,

loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale colored stools and itchy skin, stomach area (abdominal) pain.

Other possible side effects include:
altered sense of taste, diarrhea, high blood pressure, muscle aches

Dr. Ashish K. Jha, White House, Covid-19 coordinator

The new White House Covid czar says avoiding all virus infections isn’t the goal of U.S. pandemic policy.

Paxlovid, push to reach the vulnerable

Doctors are too hesitant to prescribe the drug

https://en.wikipedia.org/wiki/Ashish_Jha

Senior Advisor at Albright Stonebridge Group

https://www.politico.com/newsletters/transition-playbook/2021/03/23/the-blob-abides-492214

The firm advises clients on international policy and global markets

Patrick Vallance

From 2012 to 2018, he was President of Research and Development at global pharmaceutical company, GlaxoSmithKline (GSK)

https://www.telegraph.co.uk/news/2020/09/23/revealed-sir-patrick-vallance-has-600000-shareholding-firm-contracted/

Cashed £5,000,000 GSK shares

Future jobs of FDA’s haematology-oncology reviewers

https://www.bmj.com/content/354/bmj.i5055.full

https://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry?t=1651600609470

More than a quarter of the Food and Drug Administration employees

(who approved cancer and hematology drugs from 2001 through 2010)

left the agency and now work or consult for pharmaceutical companies,

Source

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57 thoughts on “Paxlovid, evidence base?”

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