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About PAXLOVIDAbout
PAXLOVID

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High-Risk Factors & When to TreatDosingMechanism of ActionEfficacyEfficacy

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Trial DesignResultsReal-World EvidenceDrug InteractionsSafetyAccess & ResourcesAccess & Resources

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Full Prescribing Information and Patient InformationIndication HCP EUA WebsitePatient Website

PAXLOVID was evaluated in the EPIC-HR pivotal trial

PAXLOVID was evaluated in the EPIC-HR pivotal trial This trial included a geographically diverse group of 2113 participants1,2Trial Design1,2

EPIC-HR was a phase 2/3, randomized, double-blind, placebo-controlled trial in nonhospitalized, symptomatic adults with SARS-CoV-2 infection with ≥1 risk factor for progression to severe disease (N=2113).
mITT (modified intent-to-treat) analysis set=all treated participants with onset of symptoms within 3 days who at baseline did not receive nor were expected to receive COVID-19 therapeutic monoclonal antibody (mAb) treatment.1
mITT1 analysis set=all treated participants with onset of symptoms within 5 days who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.1
mITT2 analysis set=all treated participants with onset of symptoms within 5 days.1Participant inclusion criteria1
  • Unvaccinated
     
  • ≥18 years of age
     
  • Confirmed SARS-CoV-2 infection
     
  • COVID-19 symptom onset within 5 days
     

EPIC-HR was initiated on July 16, 2021, during early vaccination efforts; therefore, PAXLOVID was studied in the absence of vaccine-induced immunity.3,4

Exclusion criteria1
  • Individuals with a history of prior COVID-19 infection or vaccination
     
  • Individuals taking any medications with clinically significant drug interactions with PAXLOVID
Eligible participants also had ≥1 of the following risk factors for progression to severe COVID-191:
  • 60 years of age and older regardless of comorbidities
  • Diabetes
  • Overweight (BMI >25 kg/m2)
  • Chronic lung disease (including asthma)
  • Chronic kidney disease
  • Current smoker
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease
  • Hypertension*
  • Sickle cell disease
  • Neurodevelopmental disorders
  • Active cancer
  • Medically related technological dependence
*According to the latest CDC guidance, hypertension is a mixed-evidence high-risk factor.5Based on the latest guidance, some of this high-risk inclusion criteria may differ from the CDC’s list of high-risk factors (eg, the CDC defines high risk as age 50+).5 PAXLOVID is indicated for use in patients at high risk for progression to severe COVID-19.††This link will take you to a website that is owned and operated by the CDC. Pfizer is not responsible for the content or services of this site.mITT analysis sets1,2

Consistent primary efficacy endpoint results were observed across each analysis set: mITT, mITT1, and mITT2.1

mAb=monoclonal antibody; mITT=modified intent-to-treat.

Participant demographics1,2
PAXLOVID was studied in a population identified from sites around the world.
‡’Rest of the World’ consists of Argentina, Brazil, Colombia, Japan, Malaysia, Mexico, Peru, Russian Federation, South Africa, Republic of Korea, Taiwan, Thailand, and Turkey. 
Race & Ethnicity Percentage of Participants
White 71%
Asian 15%
American Indian or Alaska Native 9%
Black or African American 4%
Hispanic or Latino 41%
Missing or unknown  1%
Participants were able to identify as more than 1 race or ethnicity.

The baseline demographic and disease characteristics were balanced between the PAXLOVID and placebo groups.

Sex
  • 51% were male
  • 49% were female

Mean Age
45 years, with 20.7% of participants ≥60 and 79.3% of participants <60.
Most frequent high-risk factors in EPIC-HR participants2

At baseline, the most common underlying medical conditions and factors associated with high risk of progression to severe COVID-19 included in EPIC-HR were:

Condition Percentage of Participants
BMI ≥25 kg/m2 80.1%
Cigarette smoker 39.1%
Hypertension§ 31.8%
Diabetes mellitus 10.8%

The baseline demographic and disease characteristics were balanced between the PAXLOVID and placebo groups.

  • 1263 participants (59.8%) had 2 or more such characteristics or coexisting conditions
§According to the latest CDC guidance, hypertension is a mixed-evidence high-risk factor.5
Table
Trial limitations
  • PAXLOVID was approved based primarily on the EPIC-HR trial, a single randomized clinical trial that has not been replicated1
  • No vaccinated patients were included in the trial; however, 49.1% of participants were SARS-CoV-2 seropositive at baseline1,2
  • The CDC high-risk criteria differ in some aspects from the EPIC-HR trial risk factor inclusion criteria1,5
Header Drug Interactions EXPLORE MORE

Learn more about managing concomitant medications and which medications are contraindicated with PAXLOVID.

 Go to Drug Interactions LoadingReferences:1. PAXLOVID Prescribing Information. Pfizer Inc.; 2025. 2. Data on File. CSR. Pfizer Inc.; 2023. 3. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19. N Engl J Med. 2022;386(15):1397-1408. 4. Mathieu E, Ritchie H, Rodes-Guirao L, et al. Coronavirus (COVID-19) vaccinations. Our World in Data. Published March 5, 2020. Accessed February 11, 2025. https://ourworldindata.org/covid-vaccinations?country=OWID_WRL 5. Underlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed February 11, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.htmlAdditional Efficacy Information Patient Identification Many adults are living with at least 1 risk factor that puts them at high risk for progression to severe COVID-19 and may benefit from early treatment with PAXLOVID. Discover High Risk Factors Loading
References:1. PAXLOVID Prescribing Information. Pfizer Inc.; 2025. 2. Data on File. CSR. Pfizer Inc.; 2023. 3. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19. N Engl J Med. 2022;386(15):1397-1408. 4. Mathieu E, Ritchie H, Rodes-Guirao L, et al. Coronavirus (COVID-19) vaccinations. Our World in Data. Published March 5, 2020. Accessed February 11, 2025. https://ourworldindata.org/covid-vaccinations?country=OWID_WRL 5. Underlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed February 11, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html

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PP-C1D-USA-1038
Important Safety Information
 WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID
  • PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, and/or fatal events
  • Prior to prescribing PAXLOVID: 1) Review all medications taken by the patient to assess for potential drug-drug interactions with a strong CYP3A inhibitor like PAXLOVID and 2) Determine if concomitant medications require a dose adjustment, interruption, and/or additional monitoring
  • Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed
PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care. PAXLOVID is contraindicated with drugs that are primarily metabolized by CYP3A and for which elevated concentrations are associated with serious and/or life-threatening reactions and drugs that are strong CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended. Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor like PAXLOVID. Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions:
  • Alpha 1-adrenoreceptor antagonist: alfuzosin
  • Antianginal: ranolazine
  • Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
  • Anti-gout: colchicine (in patients with renal and/or hepatic impairment)
  • Antipsychotics: lurasidone, pimozide
  • Benign prostatic hyperplasia agents: silodosin
  • Cardiovascular agents: eplerenone, ivabradine
  • Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
  • HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use)
  • Immunosuppressants: voclosporin
  • Microsomal triglyceride transfer protein inhibitor: lomitapide
  • Migraine medications: eletriptan, ubrogepant
  • Mineralocorticoid receptor antagonists: finerenone
  • Opioid antagonists: naloxegol
  • PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension
  • Sedative/hypnotics: triazolam, oral midazolam
  • Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin
  • Vasopressin receptor antagonists: tolvaptan

Drugs that are strong CYP3A inducers: PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

  • Anticancer drugs: apalutamide, enzalutamide
  • Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin
  • Antimycobacterials: rifampin, rifapentine
  • Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor
  • Herbal Products: St. John’s Wort (hypericum perforatum)
 Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, which contains ritonavir, a strong CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Medications that induce CYP3A may decrease concentrations of PAXLOVID. These interactions may lead to:
  • Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
  • Loss of therapeutic effect of PAXLOVID and possible development of viral resistance
Severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with PAXLOVID. The most commonly reported concomitant medications resulting in serious adverse reactions were calcineurin inhibitors (eg, tacrolimus, cyclosporine), followed by calcium channel blockers. Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Because nirmatrelvir is coadministered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection. The most common adverse reactions in the PAXLOVID group (≥1%) that occurred at a greater frequency than in the placebo group were dysgeusia (5% and <1%, respectively) and diarrhea (3% and 2%, respectively). The following adverse reactions have been identified during use of PAXLOVID under Emergency Use Authorization: Immune System Disorders: Anaphylaxis, hypersensitivity reactions Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome Nervous System Disorders: Headache Vascular Disorders: Hypertension Gastrointestinal Disorders: Abdominal pain, nausea, vomiting General Disorders and Administration Site Conditions: Malaise PAXLOVID is a strong inhibitor of CYP3A, and an inhibitor of CYP2D6, P-gp, and OATP1B1. Coadministration of PAXLOVID with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp or OATP1B1 may result in increased plasma concentrations of such drugs and increase the risk of adverse events. Coadministration with other CYP3A substrates may require a dose adjustment or additional monitoring.Pregnancy: Available data on the use of nirmatrelvir during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy.Lactation: Nirmatrelvir and ritonavir are present in human breast milk in small amounts (less than 2%). There are no available data on the effects of nirmatrelvir or ritonavir on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition.Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. Pediatrics: The optimal dose of PAXLOVID has not been established in pediatric patients. Renal impairment increases nirmatrelvir exposure. Reduce the PAXLOVID dosage in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). Reduce the dose and dose frequency in patients with severe renal impairment (eGFR <30 mL/min), including those requiring hemodialysis. On days when patients undergo hemodialysis, the PAXLOVID dose should be administered after hemodialysis. Prescriptions should specify the numeric dose of each active ingredient within PAXLOVID. Providers should counsel patients about renal dosing instructions. PAXLOVID is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Please see Full Prescribing Information, including BOXED WARNING and Patient Information INDICATIONINDICATIONPAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.Limitations of UsePAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.Please see Full Prescribing Information, including BOXED WARNING and Patient Information
INDICATION PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Limitations of Use

PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Please see Full Prescribing Information, including BOXED WARNING and Patient Information