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How Does The COVID-19 Prevention Drug Evusheld Work And Who Should Receive It?

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COVID-19 Infection Affects Male Sex Drive, Sperm Count: Study


The U.S. Food and Drug Administration granted emergency use authorization to AstraZeneca’s COVID-19 antibody drug Evusheld on Dec. 8, 2021. Infectious disease physician Patrick Jackson of the University of Virginia explains how it works, who’s eligible and why some patients are having difficulties accessing it.

1. What is Evusheld, and how does it work?

Evusheld is the first FDA-authorized drug to prevent COVID-19 in high-risk people who aren’t adequately protected by vaccination alone. Data from a preliminary study that has not yet been peer reviewed showed Evusheld reduced the risk of symptomatic COVID-19 by 77% in unvaccinated high-risk adults.

When the immune system is exposed to a foreign protein – for example, by infection or vaccination – it produces antibodies in response to the potential threat. Evusheld is a combination of two antibodies, tixagevimab and cilgavimab, that bind to the spike protein of the virus that causes COVID-19 and prevent it from entering and infecting cells. Evusheld is a monoclonal antibody drug, meaning that it is made of mass-produced identical antibodies that originally came from a single type of white blood cell. Evusheld functions differently from antiviral drugs like molnupiravir, which work by stopping the virus from replicating within cells.

Tixagevimab and cilgavimab are versions of natural human antibodies that have been modified to last much longer in the body than they normally would. This allows Evusheld to provide COVID-19 protection for several months following a single dose. It is expected that Evusheld will need to be given about every six months to keep antibody levels high enough to be effective against the virus. Patients may need to keep getting Evusheld doses as long as there is a significant risk of COVID-19.

Evusheld is not intended to treat COVID-19, but to help prevent vulnerable patients from getting sick in the first place.

2. Who should be receiving Evusheld?

Evusheld can be used by people ages 12 and up who fall into two specific groups unable to receive the full benefit of COVID-19 vaccination.

The first group is people who are moderately to severely immunocompromised because of a medical condition or treatment. While most in this group get some protection from the COVID-19 vaccines, the immune systems of some may not be able to make enough protective antibodies on their own. This includes people receiving treatment for certain cancers, solid organ or stem cell transplant recipients and people with certain immune system disorders. People who take immunosuppressive medications, such as high-dose steroids and common autoimmune disease treatments, may also be eligible.

Evusheld is also authorized for the small number of people who had a severe reaction to the COVID-19 vaccines and can’t receive the full recommended dose regimen. It is important to note that this does not apply to common mild reactions, such as pain at the injection site or mild fever. Most people who have rare allergic reactions to the COVID-19 vaccines can still safely receive additional doses, and should discuss their options with their doctor.

3. When are you supposed to take Evusheld?

Evusheld is used to prevent COVID-19 before a person has been exposed to the virus. Currently it isn’t approved to treat someone who is already sick with COVID-19 or to prevent an infection after recent exposure.

There are several COVID-19 treatments available for high-risk people who do become infected. Unpublished data that have not yet been peer reviewed suggest that Evusheld may have a role in COVID-19 treatment in addition to prevention, but using the drug in this way has not yet been authorized by the FDA.

 

Evusheld is given at least two weeks after a patient’s last vaccine dose. This is to ensure the vaccine has had enough time to establish its full protective effects. This recommendation may change as researchers learn more about how vaccines and monoclonal antibodies like Evusheld work together.

Generally, immunocompromised people who can get vaccinated and boosted for COVID-19 should do so in addition to taking Evusheld. While they may not be as strongly protected as others, vaccination is still likely to provide some benefit.

4. How effective is Evusheld against variants?

One significant shortcoming of monoclonal antibody drugs like Evusheld is that they are not all equally effective against different variants of the virus that causes COVID-19.

Evusheld entered clinical trials before the omicron variant dominated infections around the world. Lab studies have given conflicting results on how effective Evusheld might be against the omicron subvariants currently circulating in the U.S. It also isn’t clear how well those lab studies predict real-world protection against COVID-19.

In response to this concern, the FDA recently doubled the authorized dose of Evusheld. The idea is that if the Evusheld antibodies are less effective against one of the omicron subvariants, more antibodies might still offer protection. Future variants may make Evusheld more or less effective.

5. Are there any other preventive treatments?

Other than the vaccines, Evusheld is currently the only drug approved or authorized in the U.S. for the prevention of COVID-19.

Until recently, two other monoclonal antibody drugs, casirivimab-imdevimab and bamlanivimab-etesevimab, were used to prevent disease in people who were recently exposed to COVID-19. Unfortunately, these drugs are not effective against the omicron variant that is now the source of almost all U.S. COVID-19 cases.

 

Researchers are looking into whether another monoclonal antibody, sotrovimab, which is currently being used as a treatment for COVID-19 in certain U.S. regions that have not yet been overtaken by the BA.2 omicron subvariant, could also be used to bolster immunity in immunocompromised people.

There is no evidence that drugs like hydroxychloroquine or ivermectin are useful for preventing COVID-19.

6. Why is it so difficult to access Evusheld?

The U.S. government has purchased hundreds of thousands of doses of Evusheld and is distributing these through state and territorial health departments. But that’s far fewer doses than the 7 million or more immunocompromised people, or roughly 2.7% of American adults, who might benefit from this drug. While AstraZeneca has said there are more doses, it is unclear whether the U.S. plans to purchase more.

While some hospitals have had overwhelming demand, others have unused doses. Some hospitals have had to implement allocation systems to ensure that patients at highest risk are prioritized, and those policies are not standardized. The recent FDA decision to increase the standard Evusheld dose also means that supply won’t be able to stretch as far.

Unfortunately, because Congress has failed to fund ongoing COVID-19 programs, this might further decrease the supply of Evusheld available to patients.

7. How do I know if I need Evusheld, and how can I get it?

If you think you might benefit from Evusheld, talk to your doctor about whether you qualify. The doctor can write you a prescription.

Evusheld is administered as two injections during one session, and patients are observed for one hour to monitor for rare allergic reactions. Because of limited supply and these special monitoring requirements, Evusheld is given only at certain locations. Many state health departments have websites that let you look up nearby medical centers that have Evusheld. The federal government also has a treatment locator for Evusheld and other COVID-19 drugs, though this may not be completely up to date.

Patrick Jackson, Assistant Professor of Infectious Diseases, University of Virginia

This article is republished from The Conversation under a Creative Commons license. Read the original article.





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How Does Climate Change Affect Spread Of Infectious Diseases?

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How Does Climate Change Affect Spread Of Infectious Diseases?


More than leaving lasting damage to the natural environment, climate change is also making human diseases worse, according to a study. 

Climate change is not a new problem. Since the initial connection between human activities and global warming in the late 1930s, the scientific community has been spreading information about the rapid changes the planet is experiencing due to man-made greenhouse gas emissions.

A groundbreaking study published in Nature Climate Change has revealed that climate change has worsened diseases triggered by viruses, bacteria, animals, fungi and plants.

Conducted by researchers at the Mānoa’s University of Hawaii, the study analyzed over 70,000 scientific papers for examples of direct links between known diseases and global warming. Out of the 375 diseases analyzed, the team found that 218 were affected by climate change.

Specifically, the team found that climate change-related hazards – like ice precipitation, humid environments, and warmer temperatures – could bring pathogens closer to people. This favors the proliferation of ticks, mosquitoes, fleas, birds, and mammals responsible for the spread of viruses and bacteria that cause Lyme disease, malaria, dengue, and the plague, to name a few.

The researchers also found that extreme weather events caused by climate change have resulted in the displacement and forced migration of thousands of people in the world’s most vulnerable parts, triggering more contact between humans and pathogens.

The changing weather is also pushing the pathogens to adapt and become stronger, while added stress from unsafe living conditions and lack of access to healthcare has made the human immune system weaker.

“Given the extensive and pervasive consequences of the COVID-19 pandemic, it was truly scary to discover the massive health vulnerability resulting as a consequence of greenhouse gas emissions,” said Camilo Mora, a study lead author and geography professor in the College of Social Sciences.

The study also brought some positive news. For example, some pathogens and viruses that couldn’t survive in warmer weather got reduced.

But this hardly balances out how much worse certain diseases have gotten, making it unlikely for humans to adapt in time.

“The world will need to reduce the greenhouse gas emissions that are driving climate change to reduce these risks,” the authors concluded.





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‘Forever Chemicals’ Found In Cookware, Cosmetics Linked To Liver Cancer: Study

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'Forever Chemicals' Found In Cookware, Cosmetics Linked To Liver Cancer: Study


Arecent study has revealed a concerning connection between the most prevalent type of liver cancer and some man-made chemicals found in industrial items, often known as “forever chemicals.”

It is reportedly the first study in humans to precisely relate liver cancer to “forever chemical” exposure. The term “forever chemicals” refer to polyfluoroalkyl compounds (PFAS), which can last in the environment for decades and have the potential to resist disintegration. They cause air pollution and can harm the organ tissues in exposed humans and animals, CTV News reported.

According to the Centers for Disease Control and Prevention, PFAS were first introduced in the 1930s as a revolutionary material used in the development of nonstick cookware like Teflon. They were quickly adapted to all kinds of products and packaging, from construction materials to cosmetics, that benefit from their liquid- and fire-resistant properties, New York Post reported.

In the current study, published in JHEP Reports, researchers analyzed the Multiethnic Cohort Study database, which contains data from a study of over 200,000 inhabitants of Hawaii and Los Angeles. The dataset was narrowed down to 100 participants and 50 of them suffered from liver cancer or nonviral hepatocellular carcinoma. Researchers searched for remnants of “forever” molecules in their blood and tissue samples before their diagnosis.

It showed the participants were exposed to a variety of PFAS, with perfluorooctane sulfate (PFOS) being the most prevalent one. In fact, compared to those with the least exposure to PFOS, those in the top 10% of exposure had a 4.5-fold increased risk of developing liver cancer.

PFAS compounds are used in a wide range of products. But recent findings have determined many adverse effects of PFAS, from hypothyroidism to low birth weight, according to New Atlas.

The lack of appropriate samples is partly the reason why there have been fewer human studies, according to research author Veronica Wendy Setiawan.

“When you are looking at an environmental exposure, you need samples from well before a diagnosis because it takes time for cancer to develop,” Setiawan said.

The research team also highlighted the potential effects of PFOS on the normal functioning of the liver. After analyzing the samples, they discovered evidence suggesting that PFOS may affect the liver’s natural processes for metabolizing glucose, bile acids and branched-chain amino acids.

A consequent condition known as non-alcoholic fatty liver disease, or NAFLD, is caused by the accumulation of more fat in the liver when there is disruption of normal metabolic processes.

Those with NAFLD have a substantially higher risk of acquiring liver cancer. By 2030, 30% of adults in the U.S. are expected to be impacted by NAFLD, Medical Express reported.





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Are Diabetes Medications Safe? Possible Cancer-Causing Ingredient Found In Merck Drugs

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Are Diabetes Medications Safe? Possible Cancer-Causing Ingredient Found In Merck Drugs


Diabetes drugs are once again under the microscope as the Food and Drug Administration (FDA) has found certain samples of sitagliptin contain nitrosamine – a possible cancer-causing ingredient – at levels above what is allowable by the agency.

Sitagliptin is used for the management of high blood sugar in individuals that have Type 2 diabetes, but it is not the first ingredient to raise a flag with the FDA over allowable levels that could cause cancer.

Several makes of the diabetes drugs metformin were previously recalled under the agency’s supervision, as well as a number of high blood pressure pills and Pfizer’s smoking cessation medication – Chantix – all due to a possible cancer-causing risk from an ingredient known as NDMA or N-Nitrosodimethylamine in levels higher than were allowed by the FDA.

Now Merck’s diabetes drugs Januvia, Janumet, and Steglujan, which contain sitagliptin with higher than allowable levels of nitrosamine, are being reviewed by the agency. The pills are still being permitted to be made to stave off a shortage of medication, Bloomberg reported.

In an email to the news outlet, Merck confirmed that it “recently detected a nitrosamine identified as NTTP in some batches of our sitagliptin-containing medicines,” adding that it is working with health officials globally to put in place quality control measures to ensure the drugs meet FDA interim limits.

The FDA said that it allows 37 nanograms per day of nitrosamine in a drug, but to avoid any shortages of the diabetes medications, it is allowing up to 246.7 nanograms daily. The agency did maintain that cancer risk with the allowable increase is minimal.

The FDA said, “It could be dangerous for patients with this condition to stop taking their sitagliptin without first talking to their health care professional.” It also “recommends prescribers continue to use sitagliptin when clinically appropriate to prevent a gap in patient treatment.”

Januvia is the third best-selling drug for Merck, followed by Janumet, with revenues of $3.3 billion and nearly $2 billion, respectively, in 2021 for the company, Bloomberg said.





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