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Six months after authorization, what do we know about Paxlovid?

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment
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It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” 

At the time of authorisation, the United States federal government had already purchased 10 million doses of the drug. That number soon doubled to 20 million. It’s unclear how many of those doses have been administered, but according to numbers from Pfizer, usage ramped up steadily between February and April to 80,000 doses per week.

Paxloid Usage

As COVID-19 cases rise once again and the federal government gears up to increase distribution of Paxlovid, we thought we’d take this opportunity to review information about the drug and share new information that has come to light since it was first approved.

What is Paxlovid and how was it developed?

Paxlovid was the first oral antiviral the FDA authorized to treat COVID-19. Not only is it effective but it can be taken at home, which is much more convenient than getting an IV infusion. Paxlovid is used to treat adults and children over 12 years old with mild-to-moderate coronavirus disease who are at high risk for progression to severe disease. Developed by Pfizer, Paxlovid was granted emergency use authorization (EUA) to treat COVID-19 patients based on the EPIC-HR study which showed it reduced the risk of hospitalization or death by almost 90 percent.

Paxlovid can be prescribed for anyone age 12 and older who weighs at least 88 pounds. The patient must have tested positive for COVID-19 and be considered high risk to develop severe COVID-19. High-risk patients have certain medical conditions that may predispose them to progression to severe disease. It is taken for five days, and treatment must be started within the first five days of when symptoms first appeared. Paxlovid consists of two different drugs, nirmatrelvir 150mg tablets co-packaged with ritonavir 100mg tablets. Nirmatrelvir 300mg (two tablets) is taken with ritonavir 100mg twice a day for five days.

How does the drug work?

The active drug is nirmatrelvir, a protease inhibitor, which helps keep the SARS-CoV-2 protein from replicating. SARS-CoV-2-3CL protease is an enzyme COVID-19 needs to replicate and spread. Ritonavir is another protease inhibitor, but its primary function is to keep nirmatrelvir in the body longer so that it can do its thing. Ritonavir has been around for decades and was originally approved to treat HIV.

What are its side effects?

Paxlovid seems well tolerated for now, although studies are ongoing. The drug has been in the news recently because of incidents of dysgeusia — a bad, metallic taste in the mouth. In clinical trials, 5.6 percent of patients who received Paxlovid experienced dysgeusia.

While very unpleasant, this side effect is temporary and not cause for concern. It’s a much greater issue with HIV patients, who take ritonavir for a longer period of time. There isn’t much patients can do about the taste other than wait it out.

Other possible side effects include allergic reactions, liver problems, diarrhea, high blood pressure and muscle aches. Paxlovid interacts with a long list of medications which may cause serious complications, so physicians should have a complete list of medications the patient is on.

How effective is Paxlovid?

Paxlovid is highly effective for acute COVID-19 as it reduces the risk of hospitalization by nearly 90 percent. However, there are still many unanswered questions about how effective the drug is in certain scenarios, as additional studies have not been published since emergency use authorization was granted.

A major blind spot in the data is how effective Paxlovid is at treating vaccinated patients who contract COVID-19. Since the EUA trial only focused on unvaccinated adults, we still are unable to quantify how effective the drug is for individuals who have had at least one shot, are fully vaccinated or have been boosted.

Finally, long COVID has been an area where there hasn’t been much advance in terms of remedies. Paxlovid is no exception as it has not been studied to treat long COVID.

What is “Paxlovid Rebound”?

There have been reports of “Paxlovid rebound” where patients that have taken Paxlovid, may see a recurrence of symptoms after a brief recovery. In addition, researchers have found in some cases, those with rebound infection can be contagious. Limited information from case reports seem to show these rebound infections have resulted in only mild illness thus far. The CDC has issued a Health Alert Network Health Advisory to warn of the potential risk of COVID-19 recurrence after Paxlovid treatment and advises patients to isolate for at least five days after recurrence.

Although preliminary trial data from Pfizer found rebound in 1 to 2 percent of patients, it occurred in both placebo and treatment groups. The extent of how often “Paxlovid rebound” occurs is unknown at this point as we’re not even 100 percent sure this rebound is caused by the drug. Pfizer will continue to monitor data from ongoing clinical trials and post-authorization safety surveillance. The CDC continues to recommend Paxlovid for early-stage treatment of mild to moderate COVID-19 in people that are at high risk for progression to severe disease.

How can people  in the US access Paxlovid and what is the cost?

The federal government oversees the allocation to state health departments for distribution to pharmacies, hospitals, urgent cares and other entities. Paxlovid is available by prescription from a healthcare provider and is available at no cost to the patient during the COVID-19 public health emergency.

Are changes needed to make Paxlovid more widely available?

Since February, supply has kept up with demand. Although there may be an assumption that there is not enough of this drug around, I do not believe availability is an issue thus far as recent Health and Human Services data shows more than half of the doses of Paxlovid ordered are sitting on shelves not being used.

There may be different reasons for this underutilization. The omicron variant does not seem to be as severe as previous strains, so some might think they don’t need a drug like Paxlovid since they don’t believe their mild symptoms will get much worse. Lack of advertisement probably contributes to the lack of awareness of treatments such as Paxlovid. Pfizer cannot advertise this treatment since Paxlovid is only authorized for emergency use and not available on the commercial market. It may also be hard to know where Paxlovid is available.

The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response has created a COVID-19 Therapeutics Locator website, but not many people may know about it. I’m not sure if policy changes are needed at this point, but a plan to educate the masses on Paxlovid and how to get the drug may help.

About the author

Rob Louie is EVP, Clinical Services at RemedyOne, a formulary and rebate optimization and part of Goodroot, a community of companies dedicated to reinventing healthcare one system at a time. He has more than 30 years of experience as a pharmacist.

 

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Economics

Braxia and KetaMD, CEOs McIntyre and Gumpel Speak on Acquisition

Last week, the Canadian company Braxia Scientific acquired 100% of the issued and outstanding stock of KetaMD, Inc. This is an exciting acquisition, and…

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Last week, the Canadian company Braxia Scientific acquired 100% of the issued and outstanding stock of KetaMD, Inc. This is an exciting acquisition, and in today’s interview, The Dales Report’s Nicole Hodges talks with CEOs Dr. Roger McIntyre and Warren Gumpel of Braxia Scientific and KetaMD respectively.

For some background information, KetaMD is a U.S. based, privately-held, innovative telemedicine company, with a mission to address mental health challenges via access to technology-facilitated ketamine-based treatments. Braxia Scientific is Canada’s first clinic specializing in ketamine treatments for mood disorders. They recorded revenue of $1.49m for 2022 fiscal year, ended March 31. On a year-over-year basis, revenue increased 47.5%.

Here’s some highlights from the interview.

KetaMD gives Braxia a presence in the US

Dr. McIntyre says that KetaMD gives Braxia what they’ve had as their vision from the beginning: a US presence. KetaMD is a living program. It’s already running, has infrastructure, and patients. McIntyre believes that a program like KetaMD is something Braxia’s needed to scale and obtain commercial success.

With telemedicine, Braxia has a potential to serve a gap in access. The zeitgeist of “patient going to medicine” has flipped, McIntyre says. “Now it’s medicine goes to the patient, and that is long overdue.”

COVID speeding a trend that was already happening

In 2020, 80% of physicians indicated they had virtual visits. That’s a number up from 22% the year before. But this is something that many doctors, McIntyre included, believe always should have happened. The pandemic only was the catalyst for innovation and making the option viable.

While some treatments will always need a clinic or a hospital, McIntyre believes some treatments can be done safely at home. And they are, for many chronic diseases. He feels implementing ketamine and psychedelics would be among these treatments where service could be expanded into the home. It would require careful SOPs in place, best practices, and surveillance. But he believes Braxia Scientific could deliver this with KetaMD.

Gumpel to stay as CEO of KetaMD

Gumpel says that KetaMD benefits in this acquisition from being part of the world’s most prominent researchers in depression, psychedelics, and ketamine. In the acquisition, he’ll stay on as CEO. He admits that Dr. McIntyre has been a huge part of collecting the data on the safety of ketamine treatment, and has a strong motivation to “see this thing through until most of society can access that – or at least the people that need it and want it.”

Gumpel admits he has a personal connection to ketamine treatment. As a person who has experienced bouts of depression for years, it saved his life, he says. He is grateful he was living within walking distance of ketamine treatment in Manhattan. It made him extremely aware of the accessibility gap, which in part inspired KetaMD.

Be sure to tune in for the full interview regarding Braxia and KetaMD, right here on The Dales Report!

The post Braxia and KetaMD, CEOs McIntyre and Gumpel Speak on Acquisition appeared first on The Dales Report.

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Spread & Containment

How to Use Dividends to Find the Best Tech Stock

Investors Alley
How to Use Dividends to Find the Best Tech Stock
When we talk about tech stock investing, we hear discussions of all sorts about different…

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Investors Alley
How to Use Dividends to Find the Best Tech Stock

When we talk about tech stock investing, we hear discussions of all sorts about different measures used for picking stocks.

For example, some tech investors use year-over-year revenue growth. Others subscribe to a theory that has been floating around for many years, that the secret to picking tech stocks was looking at the percentage of cash flows spent on research and development.

All too often, tech stock analysis consists of storytelling and searching for ideas that will change the world, something I’ve heard thousands of times during my career. The number of companies that actually did change the world probably totals up to a few dozen over three decades.

Some of those beat the market. Others did not.

I have found a variable that can help tech investors spot promising opportunities to identify technology companies that have higher probabilities of providing market-beating returns: dividends.

Note a stock’s dividend yield: investors who want higher dividends with an overall total return would be smart to look into high-yield tech stocks as part of their income strategy. The key to using dividends to find market-beating tech stocks is to look at the rate of their dividend growth. It doesn’t matter how high the dividend is at any given time. We want to see companies that are consistently growing their dividends.

A tech company that pays a dividend is making a statement. It tells the world: “We are generating enough cash to pay the bills, hire great people, and fund our future growth plans as well as R&D. In fact, we are generating so much cash we have some left over to pay out to our investors.”

Ideally, we want to limit our universe of companies to those who are increasing their payout by at least 20% annually. Growing a dividend at that high a rate says that things are just continuing to get better.

Once we have a universe of tech companies that are growing their payouts at high levels, we want to make sure we only own those that really do have a wonderful business that just keeps getting better. We want to use a financial checklist to make sure our companies are in excellent financial shape and have what it takes to keep growing the business.

I prefer the nine-point checklist developed by Professor Joseph Piotroski when he was at the University of Chicago – known as the “Piotroski F-Score”. This is a list of nine criteria of profitability, leverage, and efficiency. On each criterion, a firm can either get one or zero points – pass or fail.

I limit my universe of tech stocks with paid dividend growth to just two to three with the highest scores on the Piotroski checklist.

Using this simple method for picking tech stock winners has crushed the S&P 500 over the past decade and even edged at the tech-heavy NASDAQ 100.

Texas Instruments (TXN) makes the current list of technology companies with high dividend growth and outstanding fundamentals and prospects. The company makes most of its revenues from semiconductors, but it does still have some revenues from its calculators and other business machines. (I have had one of these, a Texas BAII calculator, within arm’s reach for most of my career.)

Texas Instruments had a solid second quarter and increased its guidance for the third quarter. The company has not suffered the China slowdown problems that have plagued some of their competitors so far. The brightest spot in the recent report was semiconductors being sold to the automobile industry, which were up 20%.

Although we have seen some slowdown in semiconductors due to the supply chain issues created by the pandemic, Texas Instruments has powerful tailwinds from all the developments we see in technology over the next decade.

Every one of the hottest trends in the economy—from renewable energy to artificial intelligence and everything in between—is going to increase demand for semiconductor chips. There are thousands of semiconductors in every electric vehicle, which will be another massive source of demand for the industry.

Texas Instruments has a yield of 2.5% right now, and has been growing that payout by 20.5% annually.

Another semiconductor company, Broadcom (AVGO) has the fastest-growing payout on our list right now. The company makes chips for smartphones, networking, broadband, and wireless connectivity. Broadcom’s recent purchase of Symantec’s Enterprise Business also puts it in the cybersecurity business.

Broadcom’s shares currently yield 2.97% and the payment has risen by an average of 49% annually for the past five years.

Most investors will never think of using dividends as part of the stock selection process. Rigorous testing shows that dividend growth is actually an important part of identifying companies with the potential to be huge winners.

My favorite way to invest in those companies isn’t to buy their stock, though. Instead, I like to use a special, little-known investment that lets me invest in these companies for up to 18% less than what others pay…

While collecting twice or more the dividend yield!

All without any more risk. I’m tracking 5 opportunities like that right now, and I lay them all out right here.

Only 3% of investors even know these funds exist

But using them, I can beat the market 2-to-1 while collecting 2-10X MORE yield from regular dividend stocks.

I learned this trick while I was rubbing elbows with some of the biggest fund managers in US history.

They too are buying these little known funds, cashing in huge discounts and collecting income while they do it.

Click here to learn the secret yourself.

 

How to Use Dividends to Find the Best Tech Stock
Tim Melvin

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Government

Where Carnival, Norwegian, Royal Caribbean Sit on Covid Vaccines

Do You still need to be vaccinated to go on a Royal Caribbean, Carnival, or Norwegian Cruise?

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Do You still need to be vaccinated to go on a Royal Caribbean, Carnival, or Norwegian Cruise?

Cruise line covid-19 vaccination and testing rules, which were imposed by the Centers for Disease Control and Prevention at the beginning of the pandemic, have been stricter than most. After the pandemic started in early 2020, the CDC signed a No Sail Order on March 14, 2020, which was finally lifted after nearly eight months on Oct. 30, 2020.

After the No Sail Order was lifted, the CDC enacted extremely restrictive rules and regulations to help keep passengers safe with the covid pandemic still raging throughout the world. The rules and regulations were set forth to begin to return cruise lines to operational status.

The cruise lines first had to be staffed accordingly and set up with the ability to test, treat and quarantine for covid medical emergencies. Testing for crew and passengers before embarkment and before dis-embarkment was required. The testing at pre-embarkment was a measure to protect those boarding, while the post-trip testing was for determining if an infection started on the cruise line itself. Being able to track the virus was very important in the prevention of spreading the virus and protecting patrons.

Image source: Shutterstock

Vaccination Still Not a Free Pass to Board

Once the vaccination was developed and approved, it became part of the CDC guidelines for cruise line adult passengers to have their vaccination before boarding. Even with a vaccination, guests still needed to test before they boarded the cruise lines. As the vaccine was approved for younger age groups, those age groups were then also required to have the vaccine to travel. Passengers were required to be fully vaccinated unless they are exempt by some status.

Before boarding, cruise line passengers who tested positive, as well as their travel companions, were not allowed to board, depending on the cruise line and how long the cruise may be. Some passengers were allowed to board and then isolate, others would have to reschedule their trip. Trip insurance is a good buy these days.

Cruise Lines Letting Loose on Vaccine Policies

Carnival Cruise Line  (CCL) - Get Carnival Corporation Report has now removed pre-cruise testing for vaccinated guests and also welcomes unvaccinated guests to travel. Fully vaccinated guests traveling less than 16 nights with the cruise line will no longer be subjected to testing, but still must provide proof of their vaccination status. Unvaccinated travelers will only need to provide a negative covid test result to board the ships. All rules and regulations are still subject to the destination country’s guidelines.

According to the Healthy Sail Center for Royal Caribbean  (RCL) - Get Royal Caribbean Group Report, the cruise line has updated its covid vaccination protocol. The cruise line will now allow passengers regardless of vaccination status to board in some ports if the travelers meet the testing requirements. Testing requirements vary by cruise departure and destination. Check the cruise lines port departure for updated information on requirements.

There is, however, a major exception, at least for now, which is obvious when you look at the specific wording shared by the cruise line:

"Starting with September 5 departures, all travelers regardless of vaccination status can cruise on the following itineraries, as long as they meet any testing requirements to board.

  • Cruises from Los Angeles, California.
  • Cruises from Galveston, Texas.
  • Cruises from New Orleans, Louisiana.
  • Cruises from a European homeport.

Notice that Florida, a major port for the cruise line, is not currently on the list.

In the U.S. aside from Florida, any guest with a valid negative covid test within the last three days will be able to board. These guests will also not be required to take a second test at the boarding terminal. Fully vaccinated guests do not need to provide proof of a negative covid test for shorter cruises. See the cruise line website for all updated information as it is subject to change.

Beginning Sept. 3, Norwegian Cruise Line  (NCLH) - Get Norwegian Cruise Line Holdings Ltd. Report is dropping its covid vaccine requirements for all its cruises. The cruise line stated that it is continuing to follow requirements for all destination countries, so guests traveling will want to check on destination vaccine and testing requirements. All guests 12 and older regardless of vaccination need to show proof of a negative test within 72 hours. Check NCL online for further instructions prior to travel.

The CDC has taken the stance that travelers are now well informed enough to make their own decisions when it comes to traveling on cruise lines. The travelers are taking their own assumed risk for their health and well-being. Cruise lines are now welcoming this new freedom for their passengers. 

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