Lagevrio (molnupiravir)

Lagevrio (molnupiravir)

Hello, I’m Dr. Colin Shepard. I serve as the CDC Liaison to the HHS Assistant Secretary for Preparedness and Response, also called ASPR. I want to talk about one of the therapeutics that can help people with COVID-19—Lagevrio, also known as molnupiravir.

What is Lagevrio?

Lagevrio is an oral antiviral used to help fight the coronavirus infection by stopping the coronavirus from replicating in the body. This lowers the viral load, reducing the chances of the illness progressing to more serious symptoms and hospitalization.

Who is eligible for Lagevrio?

Lagevrio is for adults who are at high risk for developing serious symptoms of COVID-19 that may lead to hospitalization or death. For more information about who is at high risk, please see the resources provided in the description. Lagevrio is for people who have a positive COVID-19 rapid or PCR test with mild to moderate symptoms and who are not in the hospital. It should be administered as early as possible but needs to be given within 5 days of symptom onset.

How is Lagevrio administered?

Lagevrio requires a prescription. It is available through a pharmacy or health care clinic, including Test to Treat locations where these antivirals are being distributed for use at home. Patients will take pills twice a day for 5 days.

What are the limitations of use for Lagevrio?

Lagevrio is not for everyone. The medication is not for anyone under the age of 18 or pregnant women. It is not appropriate to start Lagevrio if you are already hospitalized for COVID-19. There are no known drug interactions with Lagevrio.

Lagevrio is one of several COVID-19 therapeutic options. Watch the other Outpatient COVID-19 Therapeutics Videos in this series for more information. Visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can connect with ASPR on social media platforms to stay up to date on our latest posts and information that we share. Please email any questions to COVID19therapeutics@hhs.gov.

Thank you for your time.

Lagevrio is not authorized for:

• Use in patients less than 18 years of age.
• Initiation of treatment in patients requiring hospitalization due to COVID-19. Benefit of treatment with Lagevrio has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19.
• Use for longer than 5 consecutive days.

Pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Yes. State and territorial health departments can order product through the HHS Health Partners Ordering Portal. Dispensing sites began receiving product in December 2021.

Rebound, which is defined as experiencing recurrence of symptoms and/or SARS CoV-2 antigen positivity after initial resolution, has been observed not only among patients treated with Lagevrio but also occurs in patients receiving no treatment and in patients treated with other COVID-19 therapeutics.

Recent studies suggest patients experiencing rebound have an extremely low probability of developing severe COVID-19. Further studies on this phenomenon are ongoing.

Additional guidance on the management of patients experiencing rebound is available.

The dosage in adult patients is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food, starting within 5 days of symptom onset. For administration via certain feeding tubes, refer to the FDA Fact Sheet on Lagevrio.

• Email any questions to COVID19therapeutics@hhs.gov.
• NIH Therapeutic Management of Non-hospitalized Adults With COVID-19
• FDA Fact Sheet for Health care Providers for Lagevrio
• Side-by-Side Outpatient Therapeutics Overview
• Therapeutics Clinical Implementation Guide
• COVID-19 Therapeutics Decision Aid

Lagevrio is for adults 18 years and older who are at high risk for developing serious COVID-19 disease including hospitalization and/or death. Lagevrio should be considered for non-hospitalized patients who meet all of the following criteria:

• Have current diagnosis of mild to moderate COVID-19 & are within 5 days of symptom onset.
• Have one or more risk factors for severe COVID-19.
• Alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

Please see the FDA Fact Sheet for Healthcare Providers for additional information on Lagevrio eligibility criteria and risks associated with use.

Per the current CDC’s Interim Clinical Considerations for COVID-19 Treatment in Outpatient guidelines, risk factors include:

• Age 50 years or older, with risk increasing substantially at age ≥ 65 years
• Being unvaccinated or not being up to date on COVID-19 vaccinations
• Specific medical conditions and behaviors

For additional information, please see at NIH’s COVID-19 Treatment Guidelines: Clinical Spectrum of SARS-CoV-2 Infection.

Antiviral treatment of outpatients at risk for severe COVID-19 may reduce the risk of hospitalization and death.

In clinical trials done prior to authorization, Lagevrio was associated with an adjusted relative risk reduction of 30% in all-cause hospitalization or death through Day 29.¹

Observational data, including from Israel² and Hong Kong³ is consistent with benefit in high-risk patients:

• 46% risk reduction in hospitalizations and death compared to the untreated for patients 75 and older²
• 49% risk reduction in death compared to non-users³

References

1. https://www.nejm.org/doi/full/10.1056/NEJMoa2116044
2. Ronza Najjar-Debbiny et al. Clinical Infectious Diseases, 2022; ciac781, https://doi.org/10.1093/cid/ciac781
3. Carlos K.H. et al. Lancet Infectious Disease 2022; doi: https://doi.org/10.1016/S1473-3099(22)00507-2

No drug interactions have been identified based on the limited available data.

No dosage adjustment is recommended based on renal or hepatic impairment or in geriatric patients.

• Veklury (remdesivir) is the other preferred treatment for mild to moderate COVID-19. Veklury is given intravenously, once daily for 3 consecutive days.
• Paxlovid (oral antiviral) is a preferred oral antiviral authorized for the treatment of mild to moderate COVID-19 illness.

Yes; a prescription from a qualified healthcare provider is required to be treated with Lagevrio.

An individual’s health care provider is the best first option for assessment and prescribing for patients who have symptoms consistent with COVID-19.

Oral antivirals, including Lagevrio, are now available at more than 40,000 locations nationwide.

Health care providers should also be proactively counseling high-risk patients about the availability of effective therapeutics and discussing a COVID-19 Action Plan with their patients.

For individuals who do not have timely access to their own health care provider, there are more than 2,700 “Test-to-treat” sites where patients can get tested, assessed for COVID-19 therapeutic eligibility, and have their prescription filled. Telehealth options are also widely available.

A call center is also available at 1-800-232-0233 (TTY 1-888-720-7489) to get help in English, Spanish, and more than 150 other languages. The Disability Information and Access Line (DIAL) is also available to specifically help people with disabilities access services. To get help, call 1-888-677-1199, Monday-Friday from 9:00 am to 8:00 pm ET or email DIAL@usaginganddisability.org.

No. Although the Agency continues to recommend that authorized prescribers use direct SARS-CoV-2 viral testing to help diagnose COVID-19, the Agency removed the requirement for positive test results effective February 1, 2023. FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a household contact with a positive direct SARS-CoV-2 viral test) who develop signs and symptoms consistent with COVID-19 may be diagnosed by an authorized prescriber as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, the authorized prescriber may determine that treatment with Lagevrio for COVID-19 is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high-risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the authorization are met, as detailed in the Fact Sheet for Healthcare Providers.

Licensed physicians and advanced practice providers are not required to perform additional laboratory testing when prescribing Lagevrio. Providers should use clinical judgement to determine if labs are necessary.

There is currently ample supply of Lagevrio.

Lagevrio should be considered as a therapeutic alternative for any COVID-19 patient who meets the eligibility criteria and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

Lagevrio is available by prescription from more than 40,000 locations nationwide.

State and territorial health departments can order product through the HHS Health Partners Ordering Portal.

Yes, health care providers and patients must be aware of the following warnings and precautions:

• Lagevrio is not recommended for use during pregnancy because of risk it may cause fetal harm. Prior to initiating treatment with Lagevrio, health care providers should assess whether an individual of childbearing potential is pregnant, if clinically indicated.
• Individuals with reproductive potential are advised to use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for appropriate time after the last dose per section 8.3 in the Fact Sheet for Healthcare Providers.
• Breastfeeding is not recommended during treatment with Lagevrio and for 4 days after final dose.
• Hypersensitivity reactions, including anaphylaxis, have been reported with Lagevrio. Please refer to the Lagevrio fact sheet for health care providers for additional information on warnings and precautions.

Oral antivirals are used to treat chronic or severe viral infections that cannot be eliminated by an individual’s natural immune response. Antivirals can function in a variety of ways to treat a virus, depending on the therapy and virus type.

A Test to Treat locator is available to help find participating sites. A call center is also available at 1-800-232-0233 (TTY 1-888-720-7489) to get help in English, Spanish, and more than 150 other languages.

The Disability Information and Access Line (DIAL) is also available to specifically help people with disabilities access services. To get help, call 1-888-677-1199, Monday-Friday from 9:00 am to 8:00 pm ET or email DIAL@usaginganddisability.org.

• Learn more about COVID-19 Treatment Information for Patients
• Fact Sheet for Patients and Caregivers