Monoclonal antibody therapy reduces the risk of hospitalization and severe disease. Pregnant people qualify for treatment, but they need to get the treatment as early as possible.

Our company, MacArthur Medical Center’s core values include INNOVATION and EXCELLENCE. We stay at the cutting edge to promote the best care possible to our patients.

Our company has started offering monoclonal antibody treatments to any pregnant patient who tests positive for Covid-19. We also refer gynecologic patients who meet the criteria. 

We share this protocol to help other practices learn of this treatment’s value and to provide a roadmap to integrate a similar option inside of their own practice

Here is what all Obgyn practices need to know.

Regneron is a medication approved by the FDA under emergency use authorization for the treatment of Covid-19 for those early in the infection and at high risk of developing severe disease.

All pregnant people diagnosed with Covid-19 are considered high risk. Pregnancy naturally suppresses the immune system which predisposes pregnant people for worse outcomes when they are infected with a viral illness. 

Regeneron is a combination of two medications, Casirivimab and Imdevimab. Regeneronmakes use of monoclonal antibodies to fight the disease. These antibodies are similar to the ones our body would naturally produce in response to infection.

Monoclonal antibodies are mass-produced in a laboratory and are designed to recognize a specific component of the Covid-19 virus — the spike protein on its outer shell. These specific antibodies interfere with the virus’s ability to attach and gain entry into human cells by targeting the spike protein. 

Monoclonal antibodies give the immune system a leg up until it can mount its response.

Most pregnant people who contract Covid-19 do well. But the studies are clear that Covid-19 increases the risk of preterm labor, ICU admission, intubation, and death.

For a practice to successfully integrate monoclonal antibody therapy into practice, we must focus on teamwork. Everyone in the practice should have some basic knowledge of this treatment option to make certain cases are identified and referred early in the infection when the treatment is most effective. 

We must work together to give our patients to best chance possible to stay healthy after being diagnosed with Covid-19. 

Remember: Getting vaccinated against Covid is the best approach. All medical providers and teammates should encourage every patient to protect themself and others. Protect our moms, babies, and children. 

Covid vaccination in pregnancy is safe and effective. There is zero credible evidence linking Covid-19 vaccines to infertility or miscarriage.

Who qualifies for monoclonal antibody therapy? 

Patients must meet at least ONE of the following criteria:

• Pregnancy
• High-risk Ethnicity Groups (Latin X or Black)
• Older age (for example, age ≥ 65)
• Obesity or being overweight (for example, BMI > 25 kg/m2)
• Chronic kidney disease, diabetes, or
• Immunosuppressive disease
• Currently receiving immunosuppressive treatment
• Heart disease 
• High Blood pressure 
• Chronic lung diseases
• Sickle cell disease
• Neurodevelopmental disorders

Additionally, patients must meet ALL the following criteria:

• 12 years of age or older
• The patient is symptomatic (not asymptomatic) and has mild to moderate illness.
• Day 10 or less since symptom onset or testing positive.
• Documented positive COVID test performed
• Not requiring Oxygen therapy 

Where is monoclonal antibody therapy done?

The State of Texas has placed The Regional Infusion Center 8th Avenue in Fort Worth near Cooks Children’s Medical Center. A physician must refer patients. Patients cannot refer themselves, and all treatments must be scheduled in advance.

Monoclonal antibody treatment is free. It is funded by the state of Texas. There is no cost to the patient.

The RIC (Regional infusion Center operates seven days a week from 8:00 AM — 6:00 PM. 

How can a practice refer a patient for monoclonal Antibody Therapy? 

1. Confirm the patient has a positive Covid test. 
2. Confirm the patient meets the eligibility criteria listed above. 
3. Fill out the Statewide RIC Infusion Referral Form. We recommend placing a copy of this required form inside of the practice’s electronic health record to help medical assistants and referral coordinators have easy access. 
4. Fax the RIC Infusion Referral Form to 210–208–5295 or send it by email to InfusionReferral@bcfs.net
5. An Infusion Center Representative will reach out to the patient to schedule an appointment.

The post North Texas Obgyns Need to Know About Monoclonal Antibodies for Covid-19 appeared first on Medika Life.

Vaccinations are free, unlike the very costly treatment of antibody therapy. Additionally, for those who have moral, ethical, or conspiracy-based issues about taking the Covid vaccine, the same logic should apply to this treatment.

Both treatments originate from the pharma industry and if someone wanted to slip you magnetized tracking chips, the infusions offer a far more appealing medium. AI can also elicit reactions, which for some patients can prove life-threatening.

How do monoclonal antibody infusions work and do they help?

It’s the million-dollar question and before we look at data let’s examine the mechanism of action of AI’s and then consider the EUA conditions under which these drugs were approved for early Covid treatment. The text in italics below is drawn from the CMS advisory page on monoclonal antibody therapies.

This type of therapy relies on monoclonal antibodies, antibodies that are similar to the ones your body would naturally make in response to infection. Monoclonal antibodies are mass-produced in a laboratory and are designed to recognize a specific component of the Covid-19 virus — the spike protein on its outer shell.

By targeting the spike protein, these specific antibodies interfere with the virus’s ability to attach and gain entry into human cells. They give the immune system a leg up until it can mount its own response. There are however conditions attached to the use of the therapy for Covid-19 patients.

The FDA authorized the use of these monoclonal antibody therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when both of these apply:

• The patient has a positive COVID-19 test result
• The patient is at high risk for progressing to severe COVID-19, hospitalization, or both

Health care providers may administer these monoclonal antibody therapies only in settings where they have both of these:

• Immediate access to medications to treat a severe infusion reaction, such as anaphylaxis
• The ability to activate the emergency medical system (EMS)

The infusions are not without risk, which in some instances, can be life-threatening. It’s also worth noting that this risk is balanced by the advisory on who should receive the treatment. It is only recommended for those who are at high risk of developing serious Covid-19, in other words, patients with known risk factors.

A strong argument, therefore, exists that the average person who is not at high risk of developing serious Covid-19 should not be advised to take AI’s. Here are the current recommendations in place for their use.

Monoclonal antibody treatment is available to individuals who:

• Are high risk for developing severe COVID-19 and
• Have a positive COVID-19 test and have not yet been admitted to the hospital and
• Are 12 years of age or older (and at least 88 pounds)

Post-exposure preventive monoclonal antibodies are available to those who have been exposed (consistent with the CDC’s close contact criteria) and who are:

• High risk for developing severe COVID-19 and
• 12 years of age or older (and at least 88 pounds) and
• Not fully vaccinated or vaccinated but immunocompromised

You can also qualify for treatment if you’ve been exposed to someone who is Covid positive and you are in a high-risk category. There is evidence to suggest that there is a mildly prophylactic benefit for this group of patients.

Does it work?

Realistically, it’s almost impossible to tell and it isn’t difficult to figure out why. As the vast majority of people who contract Covid-19 recover on their own, this muddies the water. Simply put, how do we know if the patient has simply recovered as he was never going to develop serious Covid to start with, or did the treatment itself prevent the development of serious Covid?

Data are mixed on outcomes and as with most studies conducted at the behest of the pharma industry, there is the intent to skew the data in favor of the treatment. In this instance, however, the presence of a control group is of absolutely no benefit for the reason given above.

As a prophylactic, there may well be some benefit, but again, timing and speedy administration are of the utmost importance for the treatment to have any effect. That alone renders AI therapy more or less redundant for the majority of Americans. Here’s why.

Timing is everything

Like most things in life, the timing of the administered infusion matters. Leave it too late and you may as well not bother. The antibody infusions are only helpful if administered in the early phases of a Covid infection (the first few days) and that’s where the catch lies for most people in the U.S.

Currently, most Covid tests are administered in places like CVS, Walgreens Pharmacies, urgent care, and ER’s. None of these business or medical facilities have the faintest idea of how to refer the Covid positive patient for AI treatment. That may seem completely bizarre and requires a little explanation.

Most hospitals and medical facilities deal with serious cases of Covid-19. People only arrive for care when they are struggling to breathe and by that time, antibodies are of no use as a treatment. A simple analogy is a delivery ward selling contraception to its pregnant mothers. Not much point, as the ship has already sailed.

As a newly diagnosed Covid-19 patient, right now, as the Delta variant surges, you stand absolutely no chance of getting near a doctor or nurse in most U.S. towns and cities unless you’re close to death. There simply aren’t staff or beds and if you can reach one, chances are they have even less knowledge about the AI treatment or availability than you do. They don’t have any use for it in their medical setting.

This creates a huge problem for a Covid-19 positive patient who wants or needs to take advantage of the early benefits of AI.

Hospitals are now in the process of receiving detailed instructions for assisting patients to secure a referral, but the process is convoluted, and multiple steps before appointments are confirmed will arguably remove any benefit the patient may receive from the treatment as it will be too late when it is administered.

For example, in Texas hospitals are receiving literature explaining the referral mechanisms. Interestingly, Texas will cover the costs of this therapy, and patients and providers will not be required to make any contribution.

Hospitals, Freestanding EDs, and other physicians can refer patients who meet the criteria for monoclonal antibody treatment to the RIC in Fort Worth. Patients will only be able to schedule an infusion by calling the hotline number, 1–800–742–5990, if they already have orders from their physician to get the infusion therapy. Majority of the scheduling will be completed when a physician sends their referral form to the RIC. A representative will review the referral and contact the patient to schedule a date and time.

What this means, in effect, is that a lot of back and forward paper shuffling and administrative red tape will delay actual appointment dates. So much so, that there remains no benefit to the patient when he or she eventually receives the AI therapy.

For pregnant mothers, there is the additional complication of having to have the treatment cleared with their OBGYN before they are approved for an appointment. More delays for arguably one of the most important patient communities.

There are currently no clear national guidelines and for the present time, AI remains the preserve of wealthy or influential individuals who are deemed worthy of swift treatment to minimize risk. Donald Trump. the ex-president and Greg Abbott, Texas governor, are examples in point.

This is simply another telling example of the general failure of the healthcare infrastructure to provide fair and equitable access to care for all Americans, but in this instance, it may not matter. We may never know whether this treatment is simply a cash cow being milked by political powers and pharma or a really telling tool in the fight against Covid.

A tool virtually no one has access to.

The post Monoclonal Antibody Infusions. The Plan B Emergency Contraception for Covid? appeared first on Medika Life.