All we know about Paxlovid, the COVID-19 pill that is saving lives

The efficacy of COVID-19 vaccines may decline as the virus mutates, but their rapid turnaround times and excellent initial efficacy rates mark them as a modern marvel of biotechnology.

Yet a less appreciated but widely used COVID-19 drug, called Paxlovid, is perhaps equally impressive, a testament to human ingenuity.

You may have heard of Paxlovid, an antiviral treatment made by Pfizer that is given very frequently to COVID-19 patients, vaccinated or not, when they show up at the hospital with difficult symptoms. It works very well in reducing the risk of death and hospitalization. It comes in a convenient pill form. And unlike the COVID-19 vaccine, Paxlovid has been around for years, in fact it was introduced to the market nearly twenty years ago, long before SARS-CoV-2 existed in human populations.

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But as Paxlovid is increasingly distributed to Americans, the drug is gaining a popular reputation. Given the way the pandemic has been marked by pseudoscience and social pressure to take drugs that don’t work, many Americans are rightly wondering whether Paxlovid is really a wonder drug, as it is being advertised, or whether its effectiveness outweighs its effects. occasional collateral.

We talked to experts about how the drug works, under what circumstances it might be prescribed, and much more.

So what exactly is Paxlovid?

Paxlovid is actually not one drug, but two generics packaged together: nirmatrelvir and ritonavir. The Food and Drug Administration (FDA) granted emergency use authorization of Paxlovid in December 2021 to anyone who is at least 12 years old and weighs at least 88 pounds. The drug is an oral antiviral pill that can be taken at home to help prevent people at high risk of serious illness from getting so sick with COVID-19 that they need to be hospitalized.

“This is an antiviral treatment to be used against COVID-19,” Dr. Amesh Adalja, senior Johns Hopkins Center scholar and infectious disease physician, told Salon. “It is a pill that is taken for five days and works by interfering with the way the virus processes its proteins, and has been shown in clinical studies to be highly effective in preventing serious illness, hospitalization, death and high-risk individuals. “.


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In a clinical study conducted in the second half of 2021 on unvaccinated individuals, the drug developed by Pfizer was shown to reduce the risk of hospitalization and death by 89% compared to a placebo group, with no obvious safety concerns.

In particular, Paxlovid is not new; the compound was identified in 2003 for the treatment of the severe acute respiratory syndrome (SARS) epidemic in China. SARS is closely related to SARS-CoV-2, as the names of the two viruses suggest.

How does it work?

Technically, Paxlovid is composed of two drugs: ritonavir, which is best known as a treatment for HIV / AIDS, and nirmatrelvir, which prevents replication of the SARS-CoV-2 protein. A combination of these pills inhibits the virus from infecting more cells in the body, which essentially prevents the infection from progressing. People taking Paxlovid will consume three pills twice a day for five days; in total taking 30 pills.

How can people access it?

Unlike some cold and flu medications, Paxlovid is not an over-the-counter medicine – you need a prescription from your doctor to access it.

“Once you test positive, you need to be seen by a doctor, medical assistant or nurse to get a written prescription for you,” Adalja told Salon. “There are also places that are part of the federal government’s ‘Test to Treat’ plan where there might be a registered nurse or doctor or medical assistant working in an urgent care clinic that might be housed inside a pharmacy. “.

In fact, as Adalja mentioned, a person can visit COVID.gov to find the Test to Treat database, which will help you locate pharmacies that can test and prescribe antivirals on the spot. As part of the government’s program that bought 20 million doses of the drug, Paxlovid is currently free. However, depending on a person’s health insurance status, there may be a price to pay for a doctor’s visit if they are not at a testing site for treatment.

Can anyone have Paxlovid?

FDA provides physicians with a screening checklist for eligibility for Paxlovid, but notes that “the checklist is not required to prescribe Paxlovid under the UAE. [emergency use authorization]. “

However, Adalja notes that some are more likely to benefit from the treatment than others. First, a person must take it within the first five days of symptoms appearing.

“You have to call fast – it won’t really work for people who have had symptoms for more than five days,” Adalja said. “And the data really supports its use for people at risk of serious illness, as its main benefit is preventing hospitalization.”

Works?

In short, yes, there is a lot of evidence that it works well. But the devil is in the details: the jury is still out on whether Paxlovid will benefit everyone, or just those who are at high risk of serious illness.

Last week, Pfizer said in a press release that results from a study showed the drug failed to relieve symptoms in people who they weren’t high risk of serious illness. The press release also found that there was no statistically significant reduction in hospitalizations and deaths in vaccinated patients with at least one risk factor for severe COVID-19. More data is needed to draw a conclusion about who benefits and does not benefit from this treatment, as these findings were only recently disclosed in a press release.

“The drug serves to keep high-risk people out of the hospital and clinical trial data support it, but we have no valid data on its effectiveness in patients who do not have risk factors for serious disease,” Adalja said. “It could happen over time and I think they need to do more studies to see if there are benefits for people at low risk.”

Are there any side effects?

If you’re worried about side effects, you may have heard stories about the side effect informally nicknamed “Paxlovid’s mouth,” in which the mouth and saliva taste a little odd for a while after taking the drug.

In fact, according to the FDA, the potential side effects are “altered sense of taste, diarrhea, high blood pressure and muscle aches.” But as reported by The Atlantic, “Paxolovid’s mouth is real” and “gross”. For some people, the taste is metallic. For others, it’s like “grapefruit juice mixed with soap”.

The medical term for this condition is dysgeusia, which 5.6% of patients reported in Pfizer’s clinical trials.

And then there is the so-called “Paxlovid rebound,” which is when a person’s symptoms return after treatment. According to a study published in Clinical Infectious Diseases in 483 high-risk patients treated with Paxlovid, four people (0.8%) experienced a rebound in symptoms.

“There are a lot of anecdotal reports out there, so this is something that needs a lot more study to be able to know, but I think it’s probably a real phenomenon,” Adalja said. “What is Paxlovid’s role in that, and what is the mechanism for this rebound, is what I think is really important to understand.”

Adalja said that while rebounding patients may still be contagious, anecdotally they seem to do well in warding off the virus despite a rebound.

More recently, a study published in Clinical Infectious Diseases suggests that rebound symptoms may have to do with “insufficient” exposure to the drug.

“Our main concern was that the coronavirus could develop resistance to Paxlovid, so finding out it didn’t was a huge relief,” said lead author Aaron F. Carlin, MD, PhD, assistant professor at UC San Diego School. of Medicine, in a press release. Instead, the researchers suspect that not enough of the drug reaches infected cells to prevent the virus from replicating.

Can you take Paxlovid if you are pregnant?

Yes. But like many drugs, it has not been directly tested on pregnant people.

“There is no experience in treating pregnant women or breastfeeding mothers with Paxlovid,” says the FDA. “For a mother and an unborn child, the benefit of taking Paxlovid may be greater than the risk from the treatment. If you are pregnant, discuss your options and specific situation with your doctor.

Specifically, the FDA warns that Paxlovid could affect the way your hormonal birth control works.

Can you take Paxlovid if you are reinfected?

“I wouldn’t treat someone who has a rebound again, but you can take it as many times as you want,” Adalja said, adding that the difference between a relapse and a reinfection is time. An infection after 90 days is considered a reinfection if a person tests positive 90 days after the first positive test.

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