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COVID‑19 Outpatient Therapeutics Videos and Resources For Health Care Professionals

Early intervention with COVID‑19 therapeutics may help reduce the risk of severe illness, hospitalization, and death for people with COVID‑19, especially those who are at high risk. The following videos describe treatment options for your patients, as well as ASPR’s work to help ensure that these products are distributed equitably across the United States. In addition, there is an extensive resource section to help you find more information about each of the topics mentioned.

ASPR and the COVID‑19 Response

In this video, Cicely Waters, Director of External Affairs for ASPR, explains ASPR’s role in emergency response, including the COVID-19 pandemic. She also discusses ASPR’s role in distributing COVID‑19 therapeutics and describes ASPR resources that health care providers can use to: learn the latest on these therapeutics, share this information with their networks, and educate their patients about treatments for COVID‑19.

 

COVID‑19 Therapeutic Options Videos

These videos describe outpatient COVID‑19 treatment options, including patient eligibility for and administration of these therapeutics.

Overview: COVID‑19 Therapeutics

 

COVID‑19 Therapeutics

Hello, I’m Dr. Derek Eisnor. I’m a Medical Officer for the Office of the Assistant Secretary for Preparedness and Response, or ASPR. ASPR operates within the U.S. Department of Health and Human Services, or HHS. Understanding which COVID‑19 therapeutics are available for outpatient use and who is eligible will improve access and help ensure these lifesaving therapeutics are delivered in a fair and equitable manner.

What therapeutic options are available?

There are different therapeutic options for outpatients and inpatients who are in the hospital. This presentation focuses on outpatient COVID‑19 therapeutic options. To be eligible for these outpatient therapeutic options your patient should be at a higher risk for developing serious symptoms of COVID‑19. Other eligibility conditions and criteria apply for each treatment. To learn more about who is at high risk and COVID‑19 treatment options, please see the other videos in this series as well as in the links in the description.

What are the outpatient therapeutic options?

Outpatient treatments can be divided into three categories: PrEP or pre-exposure prophylaxis—a preventative treatment for high-risk individuals before a possible exposure, PEP or post-exposure prophylaxis, and therapy for those who test positive for COVID‑19.

What therapies are available for PrEP?

A preventative PrEP treatment available is Evusheld, a combination long-acting monoclonal antibody. Evusheld can help keep vulnerable people as well as those taking immunosuppressive drugs, such as chemotherapy or steroids, from progressing to severe disease or hospitalization if they later become COVID‑19 positive. The drug can provide protection through prevention of severe illness in people not expected to mount an adequate immune response. Evusheld is not a substitute for vaccination.It is administered as intramuscular injections.

What therapies are available for PEP?

There are currently no PEP outpatient treatments. Doctors and scientists are working together studying new and improved treatments as the virus variants change during the pandemic.

What therapies are for people who test positive for COVID‑19 and are not in the hospital?

If you test positive for COVID‑19 there are different types of therapeutic treatments you may receive: oral antivirals, intravenous (IV) antivirals, and monoclonal antibodies, also called mAbs. These treatments are only effective at preventing severe disease or hospitalization if started within a specific limited time frame from onset of illness. Oral antiviral medications are pills and must be started within 5 days of symptom onset. Intravenous antivirals and mAbs need to start within 7 days of symptom onset.

Oral antivirals include Paxlovid or Lagevrio (or molnupiravir). They help fight the coronavirus infection by stopping the virus from replicating in the body. This lowers the viral load reducing the chances of the illness progressing to more serious symptoms and hospitalization. These medications need a prescription and must be started within 5 days of when symptoms first appear. They are taken as pills at home twice a day for 5 days.

ASPR distributes oral antiviral pills directly to participating Test to Treat pharmacy-based clinics and long-term care pharmacies making treatments available to eligible people in more locations. Test to Treat is an important initiative that allows people, who have limited access to a healthcare provider, an alternative location to get tested and, if positive and eligible, receive a prescription and medication—all at one location. For more information about the Test to Treat and Long-Term Care programs, please see the other videos in this series and the resources provided in the description.

Veklury is an intravenous antiviral. Like the oral antivirals, it fights the coronavirus infection by stopping the virus from replicating in the body, lowering the viral load. Veklury is given as an intravenous infusion and must be started within 7 days of symptom onset. It can be given in a number of locations like an infusion center once a day for 3 days.

A COVID‑19 mAb includes bebtelovimab. It helps fight the coronavirus infection by blocking the virus from attaching to the body’s cells. This reduces the chances of the illness progressing to more serious symptoms and hospitalization. Bebtelovimab is given intravenously and must be taken within 7 days of symptom onset. It is administered one time.

How does one find COVID‑19 therapeutics?

To find available therapeutics in your area, you can use the Test to Treat Locator for antivirals and the COVID‑19 Therapeutics Locator for all treatments. To learn more about each of these treatments, watch the other Outpatient COVID‑19 Therapeutics Videos in this series. 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.

IMPORTANT Bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize the current coronavirus variants.

This overview video featuring Derek Eisnor, MD, medical officer in ASPR’s Division of Clinical Development, explains the outpatient treatment options that are available to treat your COVID‑19 patients with mild to moderate symptoms.

Evusheld

 

Evusheld

Hello, I am Dr. Michael Anderson. I’m an intensive care physician and a senior advisor at the Department of Health and Human Services Office of the Assistant Secretary for Preparedness & Response, also known as ASPR. At ASPR I help guide the novel COVID‑19 therapeutics as well as focus on a pediatric response agenda. I’d like to talk with you about a very unique therapeutics that is used to prevent infection and that’s called Evusheld.

What is Evusheld?

Evusheld is a long-acting antibody used for pre-exposure prophylaxis, also known as PrEP. The drug can provide protection against infection of people not expected to mount an adequate immune response.

Who is eligible for Evusheld?

Evusheld is for adults and children 12 and over who are immunocompromised due to a medical condition or immunosuppressive medications. Evusheld is also for rare individuals for whom vaccination is not recommended due to a medical, health reason. Evusheld of course is not a substitute for vaccination.

As a PrEP treatment, Evusheld is for people not currently infected with COVID‑19 and who have not been recently exposed to COVID‑19. Evusheld is not a treatment for active COVID‑19 infections. For more information about patient eligibility and administration of Evusheld, please see the resources found in the description and other videos in this series.

How is Evusheld administered?

Evusheld is given as two intramuscular injections at one sitting, ideally into the gluteal muscle. Before going home, patients should monitored for one hour after injection for any signs of severe but very rare allergic reactions.

What are the limitations of use for Evusheld?

Evusheld is not for people who test positive for COVID‑19. Vaccination and boosters are recommended for immunocompromised individuals and any close contacts or household members. Evusheld does require a prescription and patients should wait at least 2 weeks after getting the COVID‑19 vaccine before receiving Evusheld. Evusheld should be administered with caution in patients who have a coagulopathy or patients at risk for cardiovascular disease.

Evusheld is one of several COVID‑19 therapeutics. I urge you to watch the other videos in this outpatient series. Also visit us online at https://aspr.hhs.gov/COVID‑19 and please see the resources linked in the description to learn more. You can also connect with ASPR on social media platforms to stay up to date on our latest posts and information. And if you have any questions I urge you to email us at COVID19therapeutics@hhs.gov.

Thank you for your time.

Evusheld protects those who are not expected to mount an adequate immune response following vaccination. This video featuring Michael Anderson, MD, MBA, senior advisor at ASPR, discusses the use of Evusheld, a long-acting monoclonal antibody combination for use in pre-exposure prophylaxis (PrEP) for COVID‑19.

Paxlovid

 

Paxlovid

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—Paxlovid.

What is Paxlovid?

Paxlovid 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 Paxlovid?

Paxlovid is for adults and children 12 and older who are at high risk for developing serious symptoms of COVID‑19 that may lead to hospitalization and/or death. For more information about who is at high risk, please see the resources provided in the description.

Paxlovid 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 Paxlovid administered?

Paxlovid requires a prescription and 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 a combination of pills twice a day for 5 days.

What are the limitations of use of Paxlovid?

Paxlovid is not for everyone. There are serious drug interactions with some of the ingredients that need to be considered. Paxlovid is not recommended for patients with severe renal or hepatic impairment. It is not appropriate to start Paxlovid if you are already hospitalized for COVID‑19.

Paxlovid 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.

Paxlovid is an oral antiviral pill authorized for the treatment of mild to moderate COVID‑19. In this video, Colin Shepard, MD, CDC liaison to ASPR, provides more information about the at home use of Paxlovid for people who test positive for COVID-19.

Lagevrio

 

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.

Watch this video, featuring Colin Shepard, MD, CDC liaison to ASPR, as he discusses Lagevrio (molnupiravir), an oral antiviral authorized for the treatment of mild to moderate COVID‑19 for certain adults whom alternative COVID‑19 treatment options are not clinically appropriate.

Veklury

 

Veklury (remdesivir)

Hello, I am Dr. Michael Anderson. I’m an intensive care physician and a senior advisor at the Department of Health and Human Services Office of the Assistant Secretary for Preparedness & Response, also known as ASPR. At ASPR I help guide the novel COVID‑19 therapeutics as well as focus on a pediatric response agenda. I want to talk about one of the therapeutics that can help people with COVID‑19 remdesivir, also known as Veklury®.

What is Veklury?

Veklury is an antiviral administered with an IV, used to help fight the coronavirus infection by stopping the virus 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 Veklury?

Veklury is for adults and children 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 risk, please see the resources provided in the description.

Veklury is for people who have tested positive for COVID‑19 either through PCR or rapid antigen testing. Veklury may be used for outpatients and patients in the hospital. For people who are not in the hospital, their symptoms should be mild to moderate. Veklury should be administered as soon as possible after testing positive for COVID‑19. Studies have shown it needs to be given within seven days of symptom onset to be effective at lowering your risk of progression.

How is Veklury administered?

Veklury is given as an intravenous infusion once a day for three days. The dose should be adjusted for children.

What are the limitations of use for Veklury?

Veklury is not for children weighing less than 3.5 kg or 7.7 lb. Veklury should be stopped if a liver enzyme called ALT rises to 10 times above the normal limit or if your ALT level elevation is accompanied by signs of liver inflammation. Veklury is not recommended in patients with severe kidney disease or an eGFR of less than 30 mL/min. This also applies to full-term neonates with a serum creatinine of 1 mg/dL or greater. Unlike some COVID‑19 therapies, the chances of drug interactions with Veklury are really very low.

Veklury is one of several COVID‑19 therapeutic options. I urge you to watch the other videos in this outpatient series. Also visit us online at https://aspr.hhs.gov/COVID‑19 and please see the resources linked in the description to learn more. You can also connect with ASPR on social media platforms to stay up to date on our latest posts and information. And if you have any questions, I urge you to email us at COVID19therapeutics@hhs.gov.

Thank you for your time.

In this video Michael Anderson, MD, MBA, senior advisor at ASPR, describes the use and administration of Veklury® (remdesivir), an antiviral IV drug for the treatment of certain adults and pediatric patients who have a positive SARS‑CoV‑2 test.

COVID‑19 Therapeutics Distribution

 

COVID‑19 Therapeutics Distribution

Hello, I’m Dr. Derek Eisnor. I’m a Medical Officer for the Office of the Assistant Secretary for Preparedness and Response, or ASPR. ASPR operates within the U.S. Department of Health and Human Services, or HHS. One of our top priorities is to make sure lifesaving therapeutics authorized by the U.S. Food and Drug Administration to treat COVID‑19 are delivered in a fair and equitable manner for vulnerable, underserved, and hard-hit populations.

How are COVID‑19 Therapeutics distributed?

Distribution of COVID‑19 products is organized on a national level, with the federal government distributing products to state, tribal and territorial partners who then distribute specific COVID‑19 therapeutics to individual sites. State and territorial health departments know the needs of their jurisdictions and can best determine where products should go. Updated information about distribution can be found online.

At this time, Evusheld is distributed monthly, while Paxlovid, Lagevrio (molnupiravir), and bebtelovimab are distributed weekly. Distribution is paused for REGEN-COV®, bamlanivimab/etesevimab, and sotrovimab.

Should the COVID‑19 therapeutics be stored?

We recognize that some of these products are paused for use and we recommend storing them as these drugs may be effective against future variants. Any returned product must be destroyed. If you have storage concerns, consider transferring product to another location or site in your region or health system.

When should COVID‑19 therapeutics be disposed?

We do not recommend disposing unless there is a quality concern about the product being compromised.

How can one order COVID‑19 therapeutics?

To help the process of ordering COVID‑19 therapeutics, state, tribal, and territorial partners can use a platform called HPOP, or Health Partner Ordering Portal. HPOP’s coordinated distribution system works in conjunction with 10 regional coordinators, giving these health officials maximum flexibility to get these critical drugs to the specific areas most in need in their region. This platform can be used to order, track shipments, report usage, and report inventory of these lifesaving medicines. Join us for an HPOP office hour help session where we answer questions.

How does one find COVID‑19 therapeutics?

ASPR distributes oral antiviral pills directly to participating Test to Treat pharmacy-based clinics and long-term care pharmacies making treatments available to eligible people in more locations. Test to Treat is an important initiative that allows people, who have limited access to a healthcare provider, an alternative location to get tested and, if positive and eligible, receive a prescription and medication—all at one location. For more information about the Test to Treat and Long-Term Care programs, please see the other videos in this series and the resources provided in the description.

To find available therapeutics in your area, you can use the Test to Treat Locator for antivirals and the COVID‑19 Therapeutics Locator for all treatments.

To learn more about each of these treatments, watch the other Outpatient COVID‑19 Therapeutics videos in this series. Visit us online at https://aspr.hhs.gov/COVID‑19 and please see the additional 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.

IMPORTANT Bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize the current coronavirus variants.

The federal government has helped distribute COVID-19 therapeutics to communities across the nation. In this video, Derek Eisnor, MD, Medical Officer in ASPR’s Division of Clinical Development, explains the distribution process and how you can find therapeutics to treat patients in your community.

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