Key takeaways:
In May 2023, the FDA approved Paxlovid (nirmatrelvir/ritonavir) to treat mild to moderate COVID-19. It’s approved for adults at high risk for severe illness. Paxlovid is also authorized for emergency use for mild to moderate COVID in high-risk children ages 12 and older.
Paxlovid is a combination of two oral medications. You take a total of three pills by mouth every 12 hours for 5 days.
Paxlovid side effects are generally mild, with taste changes and diarrhea being common.
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It’s been three years since the word COVID-19 became a part of our vocabulary. And in that time, many vaccines and treatment options have been researched and developed. These scientific advancements have been life saving for many people.
Paxlovid has been a mainstay of COVID therapeutic management since its initial EUA designation in December 2021. Having full FDA approval also helps us with hesitant patients not wanting to take a medication that isn't ‘FDA approved.’
In November 2021, pharmaceutical company Pfizer announced that a new antiviral pill was showing promising results in clinical trials. This medication is called Paxlovid (nirmatrelvir/ritonavir). It was the first oral medication to be authorized by the FDA for treating COVID. And in May 2023, the FDA granted full approval to Paxlovid — making it the first oral antiviral approved to treat COVID.
What is Paxlovid?
Paxlovid is a combination of two oral antiviral pills: nirmatrelvir and ritonavir. The two medications work together to help prevent hospital stays and deaths due to COVID.
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Nirmatrelvir and ritonavir are known as protease inhibitors. When SARS-CoV-2 (the virus that causes COVID) enters the body, it tries to copy itself as much as possible. The coronavirus tells our cells to create a large protein that the virus uses to multiply.
But in order for the virus to use that large protein, it needs our bodies to split it apart into smaller pieces. Our bodies have substances called proteases that break up this large protein. Protease inhibitors prevent proteases from performing this action. Without this step, SARS-CoV-2 can’t make copies of itself.
Ritonavir is a medication that’s been around since 1996. It’s usually combined with other medications to treat HIV. But with Paxlovid, ritonavir helps prevent the body from breaking down nirmatrelvir. This means larger amounts of nirmatrelvir keep working in the body longer.
Who is Paxlovid approved for?
In May 2023, Paxlovid became the first oral antiviral to be FDA approved to treat COVID. It's approved for adults with mild to moderate COVID who are at high risk of severe illness.
In an exclusive interview with GoodRx Health, Christina Madison, PharmD — founder and CEO of The Public Health Pharmacist — noted the importance of Paxlovid’s full approval, saying:
“With the ending of the federal public health emergency declaration on May 11th, it’s extremely important that we move away from utilizing COVID treatment modalities that are not under Emergency Use Authorization (EUA) status. Paxlovid has been a mainstay of COVID therapeutic management since its initial EUA designation in December 2021. Having full FDA approval also helps us with hesitant patients not wanting to take a medication that isn't ‘FDA approved.’ Also, understanding that this is a first-line agent based on the current National Institutes of Health (NIH) COVID treatment guidelines. It’s great news that this [medication] has gone through the rigorous approval process and has been found to be safe and effective.”
However, Paxlovid's initial EUA is still valid. The EUA allows Paxlovid to be given to adults and kids who are at least 12 years old and weigh 88 pounds (40 kg) or more. So healthcare providers can continue to prescribe it for eligible adolescents who are at high risk for severe illness.
How do you take Paxlovid?
Paxlovid comes as a pre-packaged course of medication. It should be started within 5 days of when you first feel COVID symptoms. For each standard dose, you will take three pills: two 150 mg nirmatrelvir tablets and one 100 mg ritonavir tablet. You should take these three pills by mouth every 12 hours for 5 days. People with kidney problems may need to take a lower dose.
Paxlovid can be taken with or without food. Each pill must be swallowed whole. Don’t split, chew, or crush the tablets. Make sure to finish all the pills prescribed to you even if you start feeling better. This will help Paxlovid to work as well as possible.
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How effective is Paxlovid against COVID-19?
Paxlovid is quite effective for preventing COVID related hospital stays and deaths. Initial clinical trials suggested Pfizer’s antiviral pill can lower this risk by up to 89% for people more likely to develop severe COVID. High-risk people include older adults, pregnant women, and those with certain medical conditions.
The EPIC-HR clinical trial compared Paxlovid to placebo (pills with no medication in them) in high-risk adults. Those who started the medication within 3 days of feeling symptoms were 89% less likely to be hospitalized or die due to COVID. Those who started Paxlovid within 5 days had an 88% lower risk.
Another clinical trial (the EPIC-SR clinical trial) looked at how effective Pfizer’s antiviral pill is for people who aren’t at high risk for developing severe COVID. Initial results were promising. But after further review, researchers found that Paxlovid didn’t have as significant of an effect in this group of people. This is why Paxlovid is only authorized and approved for high-risk people.
Does Paxlovid work against the Omicron variant?
Yes, but its benefits are most evident for older adults.
One study suggests that Paxlovid only provided significant benefit during the Omicron variant “surge” for adults ages 65 and older. But a real-world effectiveness study found that Paxlovid can be helpful for younger adults as well. This was especially true for those with weakened immune systems and underlying heart or neurological conditions. However, this study noted the benefit was greatest for older adults.
What side effects does Paxlovid have?
Paxlovid’s side effects are generally mild. In clinical trials, many side effects were reported at similar rates for study participants taking either Paxlovid or placebo.
The most common Paxlovid side effects include:
Taste changes (“Paxlovid mouth”)
Diarrhea
High blood pressure
Muscle aches
The ritonavir in Paxlovid can affect the liver. Changes to liver blood tests and yellowing of the skin or eyes (jaundice) are possible. If you have a history of or current liver problems, discuss this with your healthcare provider.
The kidneys help clear Paxlovid from the bloodstream. So if your kidneys aren’t working properly, the medication can build up and reach unsafe levels. If you have kidney problems, you may need a different dose of Paxlovid. Make sure your healthcare provider is aware of any kidney problems before taking Paxlovid.
Is Paxlovid safe to take if you’re pregnant?
Research suggests that Paxlovid is likely safe to take if you’re pregnant. A small study reviewed case reports of pregnant women who took Paxlovid to treat COVID. There was no rise in the number of complications or birth defects compared to what’s typical for the general population.
More research and larger studies are needed to confirm this safety data. But keep in mind that untreated COVID during pregnancy can cause complications for both the mother and baby. Experts currently recommend Paxlovid as a COVID treatment option to pregnant women who would otherwise qualify for a prescription.
As always, it’s important to discuss your unique risks with your healthcare provider when it comes to taking medication during pregnancy.
Does Paxlovid interact with other medications?
Yes, Paxlovid has several medication interactions. Make sure your healthcare provider and pharmacist know about all medications and over-the-counter (OTC) supplements you take. They’ll make sure Paxlovid is safe to combine with them.
If you take medications for HIV, you may already be taking ritonavir. Discuss your HIV medication regimen with your healthcare provider before starting Paxlovid.
Paxlovid can interact with many medications, including:
Colchicine (Colcrys)
Certain antipsychotic medications, such as lurasidone (Latuda)
Antiplatelet medications, such as clopidogrel (Plavix)
Blood thinners, such as rivaroxaban (Xarelto) and warfarin (Coumadin, Jantoven)
Seizure medications, such as carbamazepine (Tegretol)
Certain statin cholesterol medications, such as simvastatin (Zocor)
Certain pain medications, such as fentanyl (Duragesic)
Certain medications used to control the rhythm of the heart, such as amiodarone (Pacerone)
St. John’s wort — an OTC herbal product
This list does not include all of the possible medication interactions for Paxlovid. These are just some of the most notable. Be sure to discuss potential interactions with your healthcare provider and pharmacist.
How much does Paxlovid cost?
Currently, the U.S. Department of Health and Human Services (HHS) is providing Paxlovid and other COVID treatments at no cost.
In March 2022, the Biden administration launched the Test to Treat initiative. This allows you to get tested for COVID at a participating location. If your test result is positive, you’re able to fill a prescription for a COVID treatment, like Paxlovid, at the same location if you’re eligible. HHS offers an online locator tool to help you find a Test to Treat clinic or pharmacy. All medications and services provided at Test to Treat locations are free of charge.
How do I get Paxlovid?
Like all prescription-only medications, you can get a prescription for Paxlovid from a healthcare provider. You can also visit a Test to Treat location. These are health centers and clinics that can test you for COVID and dispense treatments right away if you have a positive test.
However, a positive test is not required to get Paxlovid. If you have mild to moderate symptoms and otherwise qualify for a prescription, you are eligible to receive Paxlovid. This means a healthcare provider can diagnose you with COVID based on symptoms and potential exposure alone.
There’s another, potentially more convenient option to get Paxlovid. Pharmacists can also directly prescribe and dispense Paxlovid right at the pharmacy. This means you can go to a local pharmacy and walk out with Paxlovid. Be sure to check with your local pharmacy to see if they currently offer Paxlovid prescriptions this way.
If you do choose to get Paxlovid directly from your pharmacist, be sure to bring the following with you:
Your most current health records (physical or electronic is fine)
Your most recent kidney and liver function tests
An up-to-date medication list, making sure to include OTC medications, vitamins, and supplements
Your medical records and kidney and liver tests must be less than a year old to get Paxlovid from your pharmacist. If you don’t have these documents available, your pharmacist can contact your healthcare provider to obtain them. But that can delay your prescription. So you may be better to contact your healthcare provider first in this instance.
Should I get a Paxlovid prescription ahead of time?
No. Experts don’t recommend stockpiling Paxlovid. Pfizer’s antiviral pill should be taken only if you currently have symptoms and they started within the last 5 days.
The bottom line
In May 2023, Paxlovid became the first oral antiviral to be FDA approved to treat COVID in adults at high-risk for severe illness. It’s also authorized to treat children ages 12 and older at high risk of severe COVID. For people at high-risk of severe illness, Paxlovid can lower the risk of hospital stays or death due to COVID by almost 90%. Paxlovid’s side effects are mild, but it can interact with many other medications.
Ask your healthcare provider whether Pfizer’s antiviral pill is a treatment option if you believe you or a loved one has COVID and are experiencing symptoms.
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References
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Pfizer Inc. (2021). Pfizer’s novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase 2/3 EPIC-HR study.
Pfizer Inc. (2022). Pfizer reports additional data on PAXLOVID™ supporting upcoming new drug application submission to U.S. FDA.
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U.S. Food and Drug Administration. (2021). Coronavirus (COVID-19) update: FDA authorizes first oral antiviral for treatment of COVID-19.
U.S. Food and Drug Administration. (2022). Coronavirus (COVID-19) update: FDA authorizes pharmacists to prescribe Paxlovid with certain limitations.
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