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By Dennis Thompson

HealthDay Reporter

WEDNESDAY, Dec. 29, 2021 (HealthDay News) – New antiviral pills for COVID-19 recently approved by the U.S. Food and Drug Administration for emergency use in high-risk people should make it easier for doctors to keep people out of the hospital.

But the initial pomp gives way to reality as doctors and public health officials struggle with the challenges of getting Pfizer and Merck antiviral pills into the hands of those who need them most.

“Yes, these antiviral drugs are great advances and, yes, I am excited about them,” said Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases. “But I come into the real world and I say we have to do this right. It’s not like waving a magic wand, and there was that in the hype, in the excitement through the media.”

Which COVID patients will be prescribed these tablets?

The Pfizer pill, Paxlovid and Merck’s molnupiravir will not be shared with everyone who is positive for COVID. They are approved for people with mild or moderate COVID who are more likely to become seriously ill – mainly those aged 65 and over or people with chronic illnesses such as heart disease, lung disease, diabetes, obesity or a compromised immune system.

“The main topic is those people who are more likely to get a serious illness that brings them to the hospital,” Schaffner said.

However, both pills come with a complex list of health problems that limit the patients they can be prescribed:

  • Paxlovid can be prescribed to children 12 and older but molnupiravir cannot, due to concerns that it could interfere with bone growth.
  • Molnupiravir it cannot be prescribed to pregnant women because it carries the risk of congenital defects. Men taking the drug are advised to use contraception for at least three months after the last dose, as the effect on sperm is not fully understood.
  • Paxlovid is not recommended for patients with severe kidney or liver problems.
  • Both medicines can interact with other medicines that a person takes.

“It’s not like going to the machine, putting in a quarter and taking out a box of chocolates,” Schaffner said. “It’s a serious prescription for medications, and health professionals need to do some checkups and education.”

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How soon should they start taking the pills?

People infected with COVID will need to start taking any antiviral pill within five days of the first symptoms in order for the medication to have any hope of calming their disease.

This means that people should “run, not walk, to get tested” if they develop any of it these symptoms, Schaffner said:

Unfortunately, the United States is in the midst of a shortage of COVID tests caused by the sudden rise in Omicron infections.

“Testing is not universal and readily available. It may take a few days for that test to return – which is more of a reason to get tested as soon as possible,” Schaffner said.

How are the pills taken?

Both antiviral drugs require five days of treatment. People taking Paxlovid will need to take three tablets at the same time, twice a day. People prescribed molnupiravir will need to take four capsules twice a day.

“People really have to be told, you can’t stop on the third day and expect any benefit. You have to implement it to the end,” Schaffner said. “At least three pills twice a day for five days – I can tell you that not everyone will do it. They really need to be encouraged to do so and strengthened and explained to them.”

There are other concerns besides the fact that the drugs will not work if the regimen is not fully implemented. Molnupiravir works by making mistakes in the genetic code of COVID-19, causing the virus to throw out the wrong copies and eventually enter the country. Some infectious disease experts are concerned that if people do not complete the entire course, it could lead to new and potentially more dangerous variants of COVID.

“We’re going to have to be in a situation where we’re really careful about how these drugs are prescribed and how they are administered, ensuring near-perfect compliance to work most effectively and not provoke resistance,” said Dr. Jonathan Abraham, assistant professor of microbiology at Harvard Medical School. .

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Where can patients get pills?

A positive COVID test is only the first hurdle that patients will face. To get any antiviral pill, they will have to take the results of their tests to a doctor or health facility and get an official prescription – they can’t just look for a cure at the pharmacy counter.

Here the FDA approval time is working against itself. The drugs were approved just before the holidays, which slowed down the process of drug distribution.

“States are currently being given a very limited number of these drugs. It will expand as we enter 2022, but it will initially have a very limited amount of these drugs available,” Schaffner said.

“States will have to tell people where they are available and how to get them. I certainly haven’t heard anything from my state health department yet,” Schaffner continued. “Where do you go with that prescription if there are only a very limited number of treatment courses available? If I’m in Nashville and they’re available in Memphis, it doesn’t help me much.”

Doctors will also be reluctant to start prescribing any pill until they fully understand all the shortcomings regarding who should and who should not get the medication, Schaffner added.

How much will the pills cost?

The U.S. federal government is buying all of its initial supplies of Paxlovid and molnupyvir, Schaffner said.

“One would have expected them to be free, but I haven’t seen a clear statement about that,” Schaffner said.

Will the tablets work against Delta and Omicron variants of COVID?

COVID vaccines work by producing antibodies that attack the spiky protein of the coronavirus – the part of the virus that helps it attack human cells. New variants are the virus’s response to these antibodies, while the coronavirus is trying to mutate its way around vaccine protection.

In contrast, antiviral drugs work by attacking other parts of the coronavirus life cycle, breaking down the means by which the virus replicates. Therefore, infectious disease experts believe the tablets will be effective against the latest variants of COVID.

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Do newly diagnosed patients with COVID have other treatment options?

People who cannot get a prescription for Pfizer or Merck can still be treated with monoclonal antibodies – cloned white blood cells that enter the bloodstream and directly attack the COVID coronavirus.

But monoclonal antibodies are much less suitable because they must be administered in a hospital or clinic, such as IV or injection.

Worse, the Omicron variant made ineffective two of three FDA-approved monoclonal antibody treatments for COVID, said Jeffrey Zients, White House coronavirus response coordinator.

“Fortunately, GlaxoSmithKline’s [GSK] Monoclonal antibody treatment is effective, so we acted quickly to ensure a greater supply of it, “Zients told a White House media briefing. , with 300,000 treatment courses available in January. “

Nevertheless, it may be more difficult for people to find and receive the remaining effective treatment with monoclonal antibodies because the other two options no longer exist.

Remdesivir, the first antiviral drug approved for the treatment of COVID, is only given to people who are hospitalized with the disease.

More information

The U.S. Food and Drug Administration has more about COVID drugs.

SOURCES: William Schaffner, MD, Medical Director, National Foundation for Infectious Diseases, Bethesda, Md .; Jonathan Abraham, MD, PhD, Assistant Professor, Microbiology, Harvard Medical School, Boston; White House Press Briefing, December 22, 2021

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