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9 Things You Need To Know About Paxlovid

9 Things You Need To Know About Paxlovid

Authored by Dr. Yuhong Dong via The Epoch Times (emphasis ours),

Do you know when Paxlovid should…

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9 Things You Need To Know About Paxlovid

Authored by Dr. Yuhong Dong via The Epoch Times (emphasis ours),

Do you know when Paxlovid should be used to treat COVID-19? Are you aware of the reasons for the mixed results of its phase 2 and phase 3 clinical trial data versus its real-life studies? Do you know what the most significant concern about Paxlovid is for its future application in treating COVID-19?

Reputed as a so-called “game-changer” oral antiviral pill to treat COVID-19, Paxlovid can prevent hospitalization and death in people who are at high risk of severe COVID-19. However, you should know that the research findings on Paxlovid are not always what they seem to be.

We will provide a balanced, unbiased review related to Paxlovid’s development history, clinical trial and real-world effectiveness data, and the drug’s advantages and limitations. We will also clarify the connection between oral antivirals and human immunity.

Summary of Key Facts

  1. Paxlovid Is Not Yet Approved by the FDA

  2. Paxlovid Should Be Used Soon After Virus Infection

  3. Clinical Trial: 89% Efficacy With Side Effects of Dysgeusia and Diarrhea

  4. Paxlovid Doesn’t Work in Younger Patients

  5. In a Real-World Study, Paxlovid Has Shown Limited Effectiveness

  6. Finding “Treatable” Patients Has Proven Challenging

  7. Drug Resistance Is a Major Concern

  8. Another Major Concern Is Paxlovid’s Interaction With Other Drugs

  9. Natural Immunity Influences the Success of Paxlovid and Other Antivirals

Pfizer’s Paxlovid contains two active ingredients. The first is nirmatrelvir (PF-07321332), a protease inhibitor that interrupts the viral replication cycle.

The action of viral protease is like a pair of scissors in the hands of a tailor. The protease can cut the long synthesized viral protein (like a piece of cloth) into various fragments with different functions. The virus will combine these protein fragments into a complete virus particle.

When the protease of the virus is inhibited, the virus is not able to replicate successfully; thus, protease is often treated as a therapeutic target by the pharmaceutical industry.

The other active ingredient of Paxlovid is an old HIV drug, ritonavir. Ritonavir is an HIV protease inhibitor that can help slow down the metabolism or breakdown of nirmatrelvir, thus maintaining nirmatrelvir’s effective concentrations.

1. Paxlovid Is Not Yet Approved by the FDA

On Dec. 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir tablets co-packaged with ritonavir tablets) to treat mild-to-moderate COVID-19.

On June 30, 2022, Pfizer filed a New Drug Application (NDA) with the FDA, seeking approval for Paxlovid. As of today, however, it has not been approved by the FDA for the treatment of COVID-19.

2. Paxlovid Should Be Used Soon After Virus Infection

A group of researchers, mainly from Pfizer Worldwide Research, published an article in Science on Nov. 2, 2021, about the discovery and characterization of Paxlovid. In vitro antiviral activity of Paxlovid has been evaluated in multiple cellular models. In vitro testing showed that Paxlovid demonstrated potent antiviral activity against SARS-CoV-2, MERS-CoV, and other similar coronaviruses.

However, the researchers noted that Paxlovid should be given very soon after a subject is infected with COVID-19.

When given to mice as early as four hours after infection with SARS-CoV-2, a 300 or 1,000 mg/kg treatment of Paxlovid was effective in reducing the SARS-CoV-2 viral load in the lungs.

This means Paxlovid should be taken as early as possible post-virus infection. That is also the rationale for the inclusion criteria: only patients within five days of symptom onset were recruited in phase 2 and phase 3 clinical trials. In other words, if the viral infection is in a late stage and the illness is more severe, Paxlovid may not be as helpful as it is for early infection.

It is worth mentioning that the start time of giving Paxlovid treatment, four hours after the virus infected animals, was even shorter than another antiviral, molnupiravir, which was dosed at 12 hours and 36 hours after virus infection in animals.

3. Clinical Trial: 89% Efficacy With Side Effects of Dysgeusia and Diarrhea

The findings of phase 2–3 double-blind, randomized, controlled trial supported by Pfizer were published on Feb. 16, 2022, in the New England Journal of Medicine.

The trial involved 2,246 symptomatic, unvaccinated, non-hospitalized adult patients who were at high risk for developing severe COVID-19 symptoms, and symptom onset was no more than five days. They were randomly selected to receive either Paxlovid 300 mg with other standard care or a placebo with other traditional medicine twice a day for five days.

The final analysis, involving 1,379 patients, showed that Paxlovid reduced the risk of COVID-19-related hospitalization or death by 89 percent, compared to the placebo group when given less than five days after symptom onset.

The main side effects observed with Paxlovid vs. control were dysgeusia (a taste disorder, 5.6 percent versus 0.3 percent) and diarrhea (3.1 percent versus 1.6 percent), both higher than the placebo group. This indicates potential side effects on the neurological and gastroenterological systems.

Again, consistent with the development concept of this drug and aligned with its animal data, the drug has to be taken at an early stage of infection. Most patients (66.3 percent) received the first dose of the trial drug or placebo within three days after the onset of symptoms.

In the real world, not many patients can take the drug in the first onset days, especially during the current Omicron era, as most patients may view their symptoms as a common cold and may not be aware of having contracted COVID-19.

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Tyler Durden Fri, 02/10/2023 - 18:20

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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Walmart joins Costco in sharing key pricing news

The massive retailers have both shared information that some retailers keep very close to the vest.

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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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Walmart has really good news for shoppers (and Joe Biden)

The giant retailer joins Costco in making a statement that has political overtones, even if that’s not the intent.

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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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