when to take paxlovid?
But it’s not meant for everyone. Only those who are at increased risk for severe disease from COVID-19 qualify for the drug, including people over age 12 who have weakened immune systems or other health conditions that increase risk of serious effects of COVID-19—like asthma, cancer, liver disease, lung disease, heart disease, and obesity. Paxlovid also comes with a list of potential adverse reactions with common drugs, such as cholesterol-lowering statins.
Because the drug is not approved by the U.S. Food and Drug Administration, but allowed under an emergency use authorization, doctors generally can’t prescribe it outside of the authorization criteria. Yet that’s not stopping people of all ages and risk profiles from asking for Paxlovid, which went from hard-to-find to much more accessible in just a few months. From December 2021, when Paxlovid was authorized, to June 2022, prescriptions for the drug have jumped from 2,500 to nearly 1 million in the U.S., according to data provided to TIME by health-data company Iqvia.
Here’s what prescribers say about who should get Paxlovid at this point in the pandemic.
Studies conducted by Pfizer before Paxlovid was authorized have found that the drug reduces the risk of hospitalization and death by up to 89% among unvaccinated people at high risk for bad COVID-19 outcomes. That efficacy has become less impressive as vaccination has increased: the company’s latest data show that Paxlovid is about 57% effective at achieving these outcomes in vaccinated people at lower risk of severe illness, such as those who have at least one of the risk factors that raise the risk of serious COVID-19 illness.
Other data that Pfizer released in June showed that the drug doesn’t significantly reduce the number of symptoms among people of any vaccination status who are at moderate risk of severe disease, compared to those not taking it. “That data changed how I see the medication, which was once hailed as a game changer,” says Dr. Anand Viswanathan, assistant professor of medicine at NYU Langone Health.
Even after the drug was authorized by the U.S. Food and Drug Administration (FDA) in December 2021, supplies were scarce, but the Biden Administration raised awareness and access to Paxlovid in March by announcing the Test to Treat program, which allowed people to get tested at places like pharmacies and receive a prescription on the spot if they were positive. Supply of the drug increased by the spring, and it went from being under-prescribed (in order to reserve limited supplies for people at highest risk) to popular among doctors and patients. On July 7, the FDA further expanded access by allowing state-licensed pharmacists to write prescriptions for anyone over age 12.
With improved access, some experts believe the drug may now be overprescribed. Paxlovid is still one of only a few COVID-19 antiviral treatments authorized by the FDA (others include a pill called molnupiravir and remdesivir, an IV therapy) so people are still asking for it. “There is probably some overprescribing or prescribing in low-risk people,” says Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security and an infectious disease physician.
Despite the drug’s increased popularity, for people who are otherwise healthy and not at high risk of getting severely ill, there are limited data supporting the benefits of taking antivirals like Paxlovid. “For the average healthy person—even a 55 year old with no major medical problems—they might not benefit and just complain of the bad taste in their mouth,” which is a common side effect of Paxlovid, says Adalja. “You have to go back to the primary purpose of prescribing Paxlovid: to prevent severe disease, hospitalization, and death.”
Even for people with symptoms who don’t have other health conditions, Adalja generally doesn’t prescribe Paxlovid unless they are ages 65 or older. That’s a common yardstick that doctors are starting to use. But there are no hard and fast rules, even when it comes to age. Dr. William Durkin, an emergency physician at Alvarado Medical Center in San Diego, recently decided not to prescribe Paxlovid to an older patient who was otherwise healthy and did not have any symptoms.
For such patients who don’t have symptoms when they test positive, doctors may write a prescription proactively and tell them to reach out if they do develop symptoms in a day or so. Because Paxlovid is most effective if taken within five days of symptoms appearing, having the prescription ready could ensure that people take advantage of the short window in which the drug works.
Used properly, an antiviral like Paxlovid can help to slow transmission as the highly contagious Omicron variants continue to spread. “We have been working diligently with clinicians, community organizations, and the general public to make people aware that these medications are available and how important it is to know your risk factors for severe COVID-19 disease,” says Dr. Mary Mercer, associate professor of emergency medicine at the University of California San Francisco and Zuckerberg San Francisco General Hospital and Trauma Center. By limiting the amount of severe disease in communities, the drug is another way to keep the virus under control.
It's the most effective treatment to prevent severe COVID – a pill called Paxlovid that studies show can be close to 90% effective in reducing the risk of severe disease.
And it's a global phenomenon. Pfizer, which manufactures the drug, just signed an agreement to import the drug to China, which is facing an unprecedented COVID surge this winter.
Yet here in the U.S., public health specialists say Paxlovid is underused. A poll taken in June and July by the COVID States Project, a consortium of several universities, found that among adults over 65 who tested positive since January 2022 and who are eligible for the drug because of their age, only 20% got a prescription.
First, let's review some basics about the drug, which came on the market in December 2021.
How does it work? As NPR reported in an earlier story: "The antiviral drug stops the virus from replicating in cells. And that could reduce the risk of long COVID as well as the risk of severe disease. "We know that one of the key factors that predict long COVID is detectable virus in the bloodstream at the time of infection," Dr. Peter Chin-Hong, an infectious disease physician at the University of California, San Francisco, wrote in an email. "So it stands to reason that interventions that prevent the virus from making more copies of itself would therefore lead to a lower risk of long COVID."
According to the prescribing guidelines, the 5-day treatment course of 3 pills, taken twice daily, should be started as soon as possible after a diagnosis of COVID-19 and within 5 days of symptom onset. Wait longer and the drug might not be effective.
Your doctor will also need to review with you all drugs you take since Paxlovid can interact with over a dozen medications and possibly cause toxicity. The potentially concerning medications include most statin drugs, which lower cholesterol, and the opioid pain reliever hydrocodone. Your doctor will determine if you can stay off any interacting drugs for 5 days or possibly take a lower dose of certain drugs while on Paxlovid.
In the U.S., not every COVID patient is eligible for a prescription. The Centers for Disease Control and Prevention recommends treatment for patients at risk of severe disease, hospitalization and death, which includes anyone who's 50 and older (risk increases with age), people who are unvaccinated and people with certain medical conditions, such as obesity, chronic lung disease, heart disease or a weakened immune system.
But exceptions can be made. A colleague who is under 50 told her doctor she was feeling worse each day after her positive COVID test and had a history of pneumonia. The doctor wrote a Paxlovid prescription.
Even if you're eligible you might have to convince a doctor to prescribe the drug. "A lot of doctors in the community and even major academic centers are reticent to prescribe out of concern that there are going to be drug interactions or think that a patient can just ride out the virus," says Dr. Priya Nori, an associate professor of medicine at the Albert Einstein College of Medicine in New York City.
There are also some side effects from Paxlovid that patients worry about and that could discourage some from seeking a prescription: a metallic mouth taste; stomach distress, including diarrhea.
But, says Michael Ganio, director of pharmacy practice and quality at the American Society of Health System Pharmacists, "a bad taste for five days is a small price to pay for a drug that can save your life."
Another cause for concern in the public could be the so-called rebound effect. A small percentage of patients, a Mayo Clinic study put it at 1%, can see COVID symptoms diminish during a course of Paxlovid but then return 2 to 8 days after finishing the medication. Are you contagious again? Possibly, says the CDC, but still unknown. So the CDC guidance is to isolate again and/or wear a mask when you are with others.
The need to have a positive test for COVID might also be a reason for the underuse of Paxlovid. Reports are that fewer people are testing if they feel symptoms such as fever, chills, sore throat and congestion. Perhaps it's due to COVID fatigue. Or people might figure that it's flu season, so maybe it's a case of the flu.
But it's not that hard to test for COVID. The do-it-yourself home antigen tests are as of this week again available for free in the U.S. – four per household – via an online request. And insurance still covers the cost of eight kits for per month for every person covered in the household.
What's more, the FDA recently extended the use-by dates for some COVID tests that have reached their expiration. You can check this chart to find out about the tests you have on hand.
The federal government also has a "Test to Treat" locator to see where you can be tested for free and, if you test positive and are eligible, leave with the drug. Spots include community health centers and some pharmacies. But even though pharmacists have been able to prescribe the drug since July, pharmacies generally don't issue prescriptions unless they have an inhouse medical clinic run by a nurse practitioner or doctor. And getting your prescription from a pharmacist — but only a pharmacist — requires some bloodwork done within the past year.
Pharmacies may also send the pills to your home for prescriptions the doctor calls in. Walgreens just announced free Paxlovid delivery via Door Dash and UberEATS; CVS will send it the same day for a fee.
For those who like to plan ahead – just in case COVID were to strike – you can make life easier by keeping an up-to-date list of any drugs you take, including dosages.
Another key factor is timing. Since Paxlovid has to be taken within five days of symptoms starting to work, you might contact your doctor's office to find out what steps to take if you test positive and think you need the drug.
No doctor? Dr. Nori says to avoid the ER or urgent care centers unless those are your only choices to obtain a prescription because while there, you could be exposed to other viruses now circulating like flu and RSV.
Other options include a telehealth visit with your doctor or an online telehealth company. Check your insurer's website to see if they partner with one.
For now, Paxlovid is free for everyone in the U.S. but that could change next year, says Jen Kates, senior vice president and director of Global Heath at the Kaiser Family Foundation. And there's no shortage. Dr. Ashish Jha, White House COVID-19 response coordinator, said at a press conference on Thursday that he expects there will be plenty of Paxlovid to take the U.S. through this winter.
But the drug might not be free forever. Congress has been resistant to adding funds for COVID treatment, says Kates, so once the current Paxlovid supply purchased by the federal government is used up, people who are insured may have to pay a copay and the uninsured will have to pay full price, "which will be expensive," says Kates.
2. When should I take Paxlovid? You have to take Paxlovid within five days of developing symptoms.
Generic name: nirmatrelvir and ritonavir Dosage form: tablets, co-packaged for oral use Drug class: Antiviral combinations
Medically reviewed by Melisa Puckey, BPharm. Last updated on May 27, 2023.
Paxlovid (nirmatrelvir tablets co-packaged with ritonavir tablets) is an FDA-approved medicine to treat adults with mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid is available under an Emergency Use Authorisation (EUA) to treat patients 12 to 18 years old for mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid should be taken as soon as possible after diagnosis of COVID-19. It is taken to decrease the number and severity of symptoms or avoid severe illness, which may lead to hospitalization or death.
Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. It may also be prescribed for an individual patient by a state-licensed pharmacist under specific conditions.
Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for the prevention of COVID-19.
Paxlovid contains two medicines: nirmatrelvir and ritonavir.
Nirmatrelvir is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19.
Ritonavir is co-administered with nirmatrelvir to help slow its metabolism in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
COVID-19 is caused by a virus called coronavirus. You can get COVID-19 through close contact with another person who has the virus. COVID-19 illnesses have ranged from very mild to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.
You should not use Paxlovid if you are allergic to the active ingredients nirmatrelvir and ritonavir, or any of the inactive ingredients. Click here for a full list of Paxlovid ingredients.
Some drugs should not be used with Paxlovid, such as those listed below.
Paxlovid should not be started immediately after discontinuation of any of the following drugs:
Tell your doctor if:
Tell your healthcare provider right away if you are or if you become pregnant. It is not known if Paxlovid can harm your unborn baby. Ritonavir can make birth control pills or skin patches less effective. Ask your doctor about other birth control options such as an injection, implant, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.
Tell your healthcare provider are breastfeeding or plan to breastfeed. It is not known if Paxlovid can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment withthis medicine.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take nirmatrelvir together with ritonavir (two tablets of nirmatrelvir and one tablet of ritonavir) twice a day for 5 consecutive days.
If you have kidney disease, talk to your healthcare provider. You may need a different dose.
Take Paxlovid as soon as possible after diagnosis of COVID-19 and within 5 days of when symptoms first appear.
You may take Paxlovid with or without food.
Swallow the tablets whole and do not crush, chew, or break them.
You may need frequent blood tests to check your liver function.
If you are taking a ritonavir- or cobicistat-containing medicine to treat hepatitis C or Human Immunodeficiency Virus (HIV), you should continue to take your medicine as prescribed by your healthcare provider.
Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days.
Nirmatrelvir: 300 mg orally twice a day Ritonavir: 100 mg orally twice a day Duration of therapy: 5 days Comments:
Use: For the treatment of mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death
For investigational use only patients 12 to 18 years old weighing at least 40 kg: Nirmatrlvir: 300 mg orally twice a day Ritonavir: 100 mg orally twice a day Duration of therapy: 5 days Comments:
Use: For the treatment of mild to moderate COVID-19 in patients who are at high risk for progression to severe COVID-19, including hospitalization or death
If you miss a dose of Paxlovid within 8 hours of the time it is usually taken, take it as soon as you remember. If you miss a dose by more than 8 hours, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of Paxlovid at the same time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
Ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken nirmatrelvir and ritonavir). Tell your doctor if you have:
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Many drugs can affect Paxlovid and some drugs should not be used at the same time. Paxlovid can interact with other medicines causing severe or life-threatening side effects or death. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Do not take Paxlovid if you are taking any of the following medicines: alfuzosin, amiodarone, apalutamide, carbamazepine, colchicine, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, finerenone, flecainide, flibanserin, ivabradine, lomitapide, lovastatin, lumacaftor/ivacaftor, lurasidone, methylergonovine, midazolam (oral), naloxegol, phenobarbital, phenytoin, pimozide, primidone, propafenone, quinidine, ranolazine, rifampin, rifapentine, St. John’s Wort (hypericum perforatum), sildenafil (Revatio®, Liqrev®) for pulmonary arterial hypertension, silodosin, simvastatin, tolvaptan, triazolam, ubrogepant, voclosporin.
These are not the only medicines that may cause serious or life-threatening side effects if taken with Paxlovid. It is very important to tell your healthcare provider about all of the medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with this Paxlovid. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines.
To check for interactions with Paxlovid click on the link below.
Nirmatrelvir 150 mg tablets
Active ingredient: nirmatrelvir Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate. The following are the ingredients in the film coating: hydroxy propyl methylcellulose, iron oxide red, polyethylene glycol, and titanium dioxide.
Ritonavir 100 mg tablets
Active ingredient: ritonavir Inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate. The following are the ingredients in the film coating: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, and titanium dioxide.
Store at room temperature 20○C to 25○C (68○F to 77○F).
Distributed by Pfizer Labs, Division of Pfizer Inc. New York, NY 10001.
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