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The Margin: What is Paxlovid, Pfizer’s COVID antiviral drug, and how effective is it?

It is the drug that has been hailed as key to saving lives in the fight against COVID-19. Vice President Kamala Harris was among those prescribed it after she tested positive for the virus.

We’re talking about Paxlovid, the antiviral medication from Pfizer

that’s considered to be another COVID game-changer. The White House is behind an effort to make the drug more widely available. President Joe Biden’s administration is reaching out to physicians to promote the treatment, and will also be distributing the drug directly to pharmacies. So far, the federal government has spent more than $10 billion to purchase enough doses of Paxlovid from Pfizer to treat 20 million people.

At the same time, there have been questions about Paxlovid’s effectiveness, with reports of rare cases of patients who were prescribed the drug seeing their COVID symptoms return.

All of this comes even as Dr. Anthony Fauci, Biden’s chief medical adviser, said that the U.S. is now out of the “acute” pandemic phase. Still, Paxlovid is seen by officials as a way to curb hospitalizations and deaths related to the virus. And Fauci also said that Paxlovid is a highly effective therapy that “we are under utilizing.”

So, what should we know about the drug? Read on to find out more.

What is Paxlovid?

Paxlovid is the brand name for a drug that is actually a combination of two drugs — nirmatrelvir and ritonavir. The former is an antiviral medication, while the latter is what’s known as a “pharmacokinetic booster” — meaning it helps boost the effect of the nirmatrelvir. (Ritonavir has also been used in combination with other medications in the treatment of HIV.)

When did Paxlovid become available?

In December 2021, the Food and Drug Administration (FDA) authorized Paxlovid in treatment of mild-to-moderate COVID-19 — specifying that it can be taken by those 12 and older who weigh at least 88 pounds and have tested positive for the virus, and “who are at high risk for progression to severe COVID-19.” Experts at the Yale School of Medicine note that the high-risk groups include those with certain underlaying conditions, such as cancer, diabetes and obesity, and older adults. But the Yale experts also note that the drug could eventually become more widely available, saying, “The hope is that the restrictions (to qualify for Paxlovid) will be relaxed over time.”

What is the course of treatment?

The drug is taken twice daily for five days, with each dose consisting of two tablets of nirmatrelvir and one tablet of ritonavir. The FDA notes that “Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.”

How effective is Paxlovid?

Pfizer said in December that data from a late-stage trial showed that Paxlovid decreased the chance of hospitalization or death from COVID-19 in high-risk adults by 89%. Pfizer chief executive Albert Bourla said in a statement that the treatment “could be a critical tool to help quell the pandemic.”  

But it doesn’t appear to work as a post-exposure prophylactic, as Pfizer recently reported that Paxlovid failed to reduce the risk of spreading the virus to household contacts.

What about the reports of patients prescribed Paxlovid whose symptoms returned?

So far, the relapse cases have been rare, though experts say we’re still learning about the drug. It’s possible that Paxlovid might be less potent against the current omicron variant, or perhaps some people are more susceptible to a relapse.

Read more: Rare cases of COVID patients relapsing pose questions for Pfizer’s Paxlovid

In the meanwhile, the FDA has advised against offering patients a second round of Paxlovid, because there’s little risk of severe disease or hospitalization among the patients who relapse.

Does the availability of Paxlovid mean you don’t need to be vaccinated?

Not at all. Getting vaccinated is still the primary defense against developing COVID-19, as well as minimizing the risk of death or severe illness from the virus. And the FDA made that very clear, saying, “Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended …The FDA urges the public to get vaccinated and receive a booster if eligible.”

Is Paxlovid being offered outside the United States?

Yes. The European Union has approved it (authorized or approved?) for use in treating COVID-19. The World Health Organization has also recommended it. And Pfizer has taken steps to boost its distribution globally, such as working with the United Nations International Children’s Emergency Fund (UNICEF) to supply the drug to low- and middle-income nations.

Does Paxlovid interact with other medications? Are there any other causes for concern?

Those who are considering Paxlovid should be aware that it does interact with several medications, as noted by Pfizer, including Alfuzosin (used to treat urinary problems) and Lovastatin (used to treat high cholesterol). As a result, doctors may not prescribe Paxlovid in some cases. And Paxlovid can cause side effects as well, ranging from allergic reactions (hives, trouble swallowing, etc.) to an altered sense of taste.

Are other COVID-19 treatments available?

Yes, other drugs can be used. The National Institutes of Health (NIH) lists some possibilities here, including bebtelovimab and molnupiravir. “A number of factors affect the selection of the best treatment option for a specific patient,” the NIH says.

What is Paxlovid’s availability?

The drug has been in short supply at some pharmacies, a critical concern that arose as the Biden administration promoted its test-to-treat program that allowed individuals quick access to Paxlovid after testing positive for COVID-19. The White House has launched the website to direct people toward information about COVID-19 treatments and where to get COVID-19 vaccines and boosters. It also points visitors toward Test-to-Treatment locations, where one can be tested and treated for COVID in one spot, and discuss treatment options like Paxlovid.

How much does Paxlovid cost?

The $500 drug treatment is being made available for free by the U.S. government. Still, as the New York Times recently noted, there is a caveat of sorts: “Uninsured patients and people with high-deductible plans who seek a prescription from a pharmacy clinic or urgent care center can get socked with consultation charges.”

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