Welcome to European Tribune. It's gone a bit quiet around here these days, but it's still going.

EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel

The medicine, which is not yet authorised in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. Paxlovid should be administered as soon as possible after diagnosis of COVID-19 and within 5 days of the start of symptoms.

'Sapere aude'

by Oui (Oui) on Mon Dec 20th, 2021 at 10:22:31 PM EST
PAXLOVID™ is a protease inhibitor combined with ritonavir, another protease inhibitor approved by the FDA to treat HIV.
archived Sun Jan 26th, 2020: "Online RUMORS say that an anti-Aids drug ..."
by Cat on Tue Dec 21st, 2021 at 01:05:27 AM EST
[ Parent ]
Coronavirus (COVID-19) Update: FDA Authorizes ["]First["] Oral Antiviral for Treatment of COVID-19
(nirmatrelvir tablets and ritonavir tablets, co-packaged [!] for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid™ [AKA "Pfizermectin"] is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
Paxlovid™ is not authorized for the pre-exposure [?!] or post-exposure prevention [?1!] of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid™ is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. The FDA has approved [licensed?] one vaccine [Pfizer-BioNTech COMIRNATY®] and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster if eligible.
by Cat on Wed Dec 22nd, 2021 at 06:40:40 PM EST
[ Parent ]
The "safety" disclaimers are nearly as frightening as long-term THREAT of SARS-CoV-2 "drug resistance" FKA  ADE AKA "gain of function" attributed to "uncontrolled or undiagnosed HIV-1 infection" CONTAINED in the World's Largest HIV Epidemic.
Because Paxlovid works, in part, by inhibiting a group of enzymes that break down certain drugs, Paxlovid is contraindicated with certain drugs that are highly dependent on those enzymes for metabolism and for which elevated concentrations of certain drugs are associated with serious and/or life-threatening reactions. Paxlovid is also contraindicated with drugs that, conversely, strongly induce those same enzymes, leading to the faster breakdown of nirmatrelvir or ritonavir, as reduced concentrations of nirmatrelvir or ritonavir may be associated with potentially losing virologic response and developing viral resistance. Paxlovid cannot be started immediately after discontinuing such medications ["washout period"] because the effects [half-life] of those medications remain after discontinuation. For a complete list of drugs that should not be taken in combination with Paxlovid, see the fact sheet for healthcare providers.

Paxlovid is not recommended in patients with severe kidney or severe liver impairment. In patients with moderate renal impairment, a reduced Paxlovid dose is needed. Patients with kidney or liver problems should discuss with their healthcare provider whether Paxlovid is right for them.

ostensibly eliminating everyone "living with" diabetes mellitus. neato.
by Cat on Wed Dec 22nd, 2021 at 07:23:52 PM EST
[ Parent ]
France says it's canceled Merck COVID-19 antiviral treatment order
Speaking to French news outlet BFM TV, the country's health minister, Olivier Véran, said that "the latest studies weren't good" and that the country hoped by the end of January to get Pfizer's Paxlovid™ antiviral treatment instead, according to Reuters. No costs will be incurred due to the cancellation, according to Véran, per the wire service.
uh oh
The data released in late November lowered expectations for the effectiveness of the COVID-19 antiviral treatment Merck developed alongside Ridgeback Biotherapeutics, called molnupiravir. While earlier data released by Merck had suggested the treatment reduced the risk of hospitalization or death by 50 percent, more data released last month following a clinical trial with high-risk individuals adjusted those expectations, indicating that it reduced the risk by only 30 percent.
archived Fri Nov 12th, 2021, Sat Dec 4th, 2021
by Cat on Wed Dec 22nd, 2021 at 11:46:05 PM EST
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Israel to Receive Tens of Thousands of Doses of Paxlovid, Pfizer's COVID-19 Pill, purchase orders and price points; contraindicated prescription of EUA competitive medication, molnupiravir, by "comorbidity" as is the custom.
age over 60 years, active cancer, chronic kidney disease, COPD, obesity, diabetes or serious heart conditions such as heart failure and coronary artery disease
or ~ 60% of US population, excluding controlled or diagnosed HIV-1 cases.
by Cat on Thu Dec 23rd, 2021 at 02:45:51 PM EST
[ Parent ]
US adds Merck[-Ridgeback] pill as 2nd ["]easy-to-use drug["]* against COVID-19
Pfizer[-BioNTech]'s pill, Paxlovid, is likely to become the first-choice treatment against the virus, thanks to its superior benefits and milder side effects.
< wipes tears > restrictions as to Reasons®
The U.S. will pay about $700 for each course of Merck[-Ridgeback]'s drug, which requires patients to take four pills twice a day for five days. A review by Harvard University and King's College London estimated it costs about $18 to make each 40-pill course of treatment.
The Merck[-Ridgeback] drug will carry a warning against use during pregnancy.
molnupiravir should not be used in patients under age 18 because it may affect bone and cartilage growth [?].
< wipes tears > slide rule efficacy, Q, V, price points, common "adverse events" (AEs)
Pfizer's pill works differently than Merck's and doesn't carry the same risks. Additionally, Pfizer's drug was ["]roughly three times more["] effective in testing, reducing hospitalization and death by nearly 90% [?!] among high-risk patients, compared with 30% for Merck's.
Federal officials have agreed to purchase enough of [molnupiravir] to treat 3.1 million people. ...The U.S. will pay about $700 for each course of Merck's drug, which requires patients to take four pills twice a day for five days. A review by Harvard University and King's College London estimated it costs about $18 to make each 40-pill [!] course of treatment.
* ie. oral not injectable (sub-cut, intra-musc, or IV d/b/a "infusion" of the body bag)
by Cat on Thu Dec 23rd, 2021 at 04:26:36 PM EST
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