COVID-19 Therapeutics Information Page

• Paxlovid Co-Pay Savings Program (Pfizer)
  Co-pay savings program for eligible commercially insured patients.
• Paxlovid Patient Assistance Program (Pfizer)
  Anyone uninsured or covered by federal programs, such as Medicare or Medicaid, can receive Paxlovid at no cost through the USG PAP operated by Pfizer. Participating dispensing sites will be sent replacement product for any dispensed product within this program.
• Lagevrio Patient Assistance Program (Merck)
  This program provides product free of charge to eligible individuals, primarily uninsured who could not afford needed Merck medicines. Individuals who don't meet insurance criteria may still qualify for this program if they attest that they have special circumstances of financial and medical hardship, and their income meets the program criteria.
• Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program
  Resource guide intended to provide overview and direction for the transition of U.S. government distribution of COVID-19 therapeutics to the commercial market.
• ISDA: Management of Drug Interactions with Paxlovid
  Resource guide for clinicians on the management of the most prescribed drug interactions with Paxlovid.
• HHS/ASPR COVID-19 Therapeutics: Resources for Healthcare Professionals and Public Health Officials
  Therapeutics clinical implementation guide, side-by-side overview of current outpatient therapies, FAQ’s on therapeutics, announcements and updates on federal COVID-19 therapeutics.
• Therapeutic Management of Nonhospitalized Adults with COVID-19
  Updated guidelines by the National Institutes for Health (NIH) for clinicians on the treatment of nonhospitalized COVID-19 patients in an outpatient setting.
• Clinical Decision Aid for Outpatient Therapeutics
  Decision tree for high-risk adult and pediatric patients to determine outpatient treatment for mild to moderate COVID-19.
• Therapeutics Expiration Date Extensions
  • ASPR Searchable Expiry Database
  • Pfizer Paxlovid Lot Expiry
• Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals
  CDC recommendations on underlying medical conditions associated with risk for severe COVID-19 that may benefit from antiviral treatment.
• HHS/ASPR COVID-19 Therapeutics Locator
  National map displaying locations that have supplies of COVID-19 therapeutics, including pharmacies with available inventory of oral antivirals.
• University of Liverpool COVID-19 Drug Interactions
  Interactive website to check drug interactions with COVID-19 medications, including Paxlovid.

Paxlovid (nirmatrelvir/ritonavir) and Lagevrio (molnupiravir) have received emergency use authorization from the Food and Drug Administration. These therapies are for the treatment of mild to moderate COVID-19 in outpatients and are not authorized for the treatment of patients hospitalized due to COVID-19 or for pre- or post-exposure prophylaxis.

Paxlovid (nirmatrelvir/ritonavir)

Paxlovid (nirmatrelvir co-packaged with ritonavir) is an oral antiviral drug that should be initiated as soon as possible within five days of symptom onset. Paxlovid is available for patients by prescription only. Prescriptions can be obtained from a health care provider or through the Test to Treat program.

• Paxlovid is currently the preferred first-line therapy for treatment of eligible patients with COVID-19. Refer to NIH: COVID-19 Treatment Guidelines: Therapeutics Management of Nonhospitalized Adults with COVID-19.
• Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in patients at high risk for severe illness from COVID-19.
• Treatment must be started within five days of symptom onset and is given as a five-day treatment course.
• Limitations
  • Paxlovid is not authorized for use in patients younger than 12 years.
  • Paxlovid is not recommended for use in patients with severe renal impairment (GFR<30ml/min) or hepatic impairment (Child-Pugh Class C).
  • For patients with moderate renal impairment (GFR 30-60ml/min), the dose of nirmatrelvir should be reduced from 300mg to 150mg (refer to FDA: Fact Sheet for Providers)
  • Due to the co-administration with ritonavir, it is critical to evaluate the patient medication regimen for potentially serious drug-drug interactions prior to prescribing Paxlovid.
    • University of Liverpool COVID-19 Drug Interactions
    • University of Michigan COVID-19 Drug Interactions
• Paxlovid FDA EUA Resources
  • Letter of Authorization
  • Fact Sheet for Healthcare Providers
  • Fact Sheet for Patients and Caregivers
  • Frequently Asked Questions: FDA EUA for Paxlovid
  • Healthcare Provider Letter about Dispensing Information
  • Paxlovid Patient Eligibility Screening Checklist Tool for Prescriber

Lagevrio (molnupiravir)

Lagevrio (molnupiravir) is an oral antiviral drug that should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Lagevrio has been authorized for adults aged 18 years and older with a current diagnosis of mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 including hospitalization or death, and for whom alternative COVID-19 therapeutic options authorized by the U.S. Food and Drug Administration (FDA) are not accessible or clinically appropriate.

Lagevrio is available for patients by prescription only. Prescriptions can be obtained from a health care provider or at a Test to Treat program.

• Lagevrio (molnupiravir) is recommended as an alternate therapy for use when the preferred therapies (Paxlovid or outpatient remdesivir) are not available, feasible for use, or clinically appropriate. See NIH: COVID-19 Treatment Guidelines: Therapeutics Management of Nonhospitalized Adults with COVID-19.
• Lagevrio is authorized for the treatment of mild to moderate COVID-19 in patients at high risk for severe illness from COVID-19.
• Treatment must be started within five days of symptom onset and is given as a five-day treatment course.
• Limitations
  • Lagevrio (molnupiravir) is not authorized for use in patients younger than 18 years.
  • Lagevrio (molnupiravir) is not recommended for use in pregnancy.
  • Lagevrio (molnupiravir) is not recommended for use while breastfeeding.
• Lagevrio (molnupiravir) FDA EUA Resources
  • Letter of Authorization
  • Dear Healthcare Provider Letter
  • Fact Sheet for Healthcare Providers
  • Fact Sheet for Patients and Caregivers
  • Frequently Asked Questions: FDA EUA for Lagevrio (FDA)
  • Lagevrio Checklist

Veklury (remdesivir) is approved by the FDA for the treatment of COVID-19 in adult and pediatric patients (ages 28 days and older and weighing at least 3 kg) who are either hospitalized or who are not hospitalized but have mild to moderate COVID-19 and are at high risk for progression to severe illness.

Veklury for non-hospitalized patients is administered as an intravenous (IV) infusion over the course of three days. It should be initiated within seven days of symptom onset.

• Veklury (remdesivir) is currently recommended as a preferred therapy for use in eligible patients if Paxlovid is not clinically appropriate (e.g., due to significant drug-drug interactions). See NIH: COVID-19 Treatment Guidelines: Therapeutics Management of Nonhospitalized Adults with COVID-19.
• Treatment should be initiated as soon as possible and within seven days of symptom onset.
• Availability
  • Due to logistical constraints on administration, outpatient Veklury (remdesivir) is not widely available.
  • Providers should check with their nearest hospital or infusion center to learn whether outpatient Veklury treatment can be arranged.
• Resources
  • Gilead: Highlights of Prescribing Information for Remdesivir
  • Information for Healthcare Providers: Prescribing, Preparation, and Storage Information
  • FDA Approved Drugs Information: Approval History, Labeling, and Related Information
  • FDA/CDER Summary Review of Veklury

Due to lack of effectiveness against currently circulating variants of COVID-19, there are currently no monoclonal antibody therapies authorized for use for the treatment or prevention of COVID-19 in the United States.