Get the Latest Guidance
COVID-19 cases can result in serious illness, hospitalizations and deaths. Treatments are available to treat or prevent COVID-19 infection for individuals at risk for severe disease progression. Please use this page to get the latest guidance on COVID-19 Therapeutics in Virginia. Therapeutics administration is best practice, these medications are available in ample supply and should be prescribed for patients who are eligible.
- February 1st, 2023 the FDA revised the EUAs for both Paxlovid and Lagevrio to no longer require positive results of direct SARS-CoV-2 viral testing. It is still recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. The scope of authorization now requires, in addition to other requirements, that adults and pediatric patients (12 years of age and older weighing at least 40 kg) have a current diagnosis of mild-to-moderate COVID-19.
- In rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. Their health care provider may determine that treatment 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 product’s authorization are met.
- January 26, 2023, Evusheld is Not Currently Authorized for Emergency Use in the U.S. The U.S. Food and Drug Administration (FDA) announced the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) has been revised and based on this revision, Evusheld is not currently authorized for use in any U.S. region at this time.
- CDC Nowcast data affirms that certain SARS-CoV-2 variants are projected to make up more than 90% of the variants currently circulating in the U.S. Since Evusheld is not expected to provide protection against COVID-19 if exposed to those variants, HHS and AstraZeneca have paused distribution of Evusheld until further notice.
- The immunocompromised, older adults, and people with disabilities face increased risks from COVID-19. HHS has ramped up efforts to get high-risk populations vaccinated, timely access to tests and lifesaving treatments. Paxlovid and Lagevrio are widely available at pharmacies, Test to Treat sites, long-term care facilities, and other sites; and states have been encouraged to set up infusion clinics for Veklury.
- Those who have used Evusheld still have options to increase their protection against serious consequences of COVID-19, like hospitalization and death. Details about these and other treatment options expected to retain activity against COVID-19 can be found here and below:
- Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
- Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
- Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
- COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in inpatient or outpatient settings.
- Individuals for whom COVID-19 vaccination is recommended should consider getting vaccinated with the primary series and an updated vaccine when eligible to increase protection against the most serious consequences of COVID-19. Please visit the FDA’s website and view ASPR’s information sheet for additional details.
- January 18, 2023, The FDA authorized a Shelf-Life Extension for Paxlovid. The Food and Drug Administration (FDA) authorized a shelf-life extension to 24 months for the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). As a result of this extension, be sure to check all inventory for the extended expiration dates. As required by the emergency use authorization, unopened cartons of Paxlovid (300 mg nirmatrelvir and 100 mg ritonavir, or 150 mg nirmatrelvir and 100 mg ritonavir), must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers. The FDA granted this extension following a thorough review of data submitted by Pfizer. To find the expiry date extension on your product, please download the data tables found on ASPR's website.
- December 22, 2022, Walgreens Launching Home Delivery of Lagevrio (molnupiravir). Walgreens will expand the oral antiviral free prescription delivery service to include Lagevrio as an option that is available to be delivered directly to the doorsteps of Americans. Patients with a prescription for Lagevrio who live in a socially vulnerable community, based on the Centers for Disease Control and Prevention (CDC) Social Vulnerability Index, will be able to have their Lagevrio prescription filled and delivered to their home at no cost via Walgreens.com and the Walgreens app. More than 8,000 Walgreens locations are offering same day delivery services to anyone who lives within 15 miles of participating Walgreens locations. The majority of Americans have access to this program (about 92% of the population). This expansion may also include the addition of Paxlovid and more details will be available at a later date.
- December 20, 2022: The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Update to emphasize to healthcare providers, public health departments, and the public that the majority of Omicron sublineages circulating in the United States have reduced susceptibility to the monoclonal antibody, bebtelovimab and the monoclonal antibody combination, cilgavimab and tixagevimab (Evusheld). Antiviral therapeutics for the treatment of COVID-19, ritonavir-boosted nirmatrelvir (PaxlovidTM), remdesivir (Veklury®), and molnupiravir (LagevrioTM), retain activity against currently circulating Omicron sublineages. These medications can prevent severe disease, hospitalization, and death and are widely available but have been underused. Read the entire alert here.
- December 2022, On-Site Product Destruction for Expired or Unauthorized USG Product is available in the Health Provider Ordering Portal (HPoP) for licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations. Below are the guidelines on what product can be destroyed.
- Guidelines for COVID-19 therapeutic product destruction:
- Only expired product or unauthorized product that can no longer be stored
- No unexpired product that is currently authorized for use can be destroyed
Sites must follow established protocols for destruction and attest in HPOP to following all regulations. Quantities of any product destroyed must be recorded in HPOP. The established returns process for each product is still an option for sites that do not have an established method for proper destruction or otherwise prefer to go through the returns process. Please reference our table under Summary of COVID-19 Therapeutics on our website.
- Guidelines for COVID-19 therapeutic product destruction:
- December 6, 2022 It is possible for an individual to become infected with COVID-19 and influenza at the same time. While an official protocol has not been established, healthcare providers may prescribe antiviral medications to treat each condition at the same time. In the outpatient setting, Paxlovid or Molnupiravir (Lagevrio) can be administered concomitantly with Tamiflu if:
- Individuals test positive for both influenza and COVID-19
- Meet criteria for administration of COVID-19 therapeutics based on Emergency Use Authorization criteria (Paxlovid Fact Sheet for Providers, Molnupiravir Fact Sheet for Providers).
- The CDC has additional information about influenza and COVID-19, including similarities and differences, found here.
- December 1, 2022 The NIH Panel added a new section on the antidiabetic agent metformin to the Guidelines. Two randomized controlled trials have evaluated the use of metformin in nonhospitalized adults with COVID-19. Neither trial demonstrated a benefit of metformin in reducing the risk of hospitalization or death in patients with COVID-19. Based on these results, the Panel recommends against the use of metformin for the treatment of COVID-19 in nonhospitalized patients and hospitalized patients, except in a clinical trial. Patients with COVID-19 who are receiving metformin for an underlying condition should continue this therapy as directed by their health care provider.
- The NIH Panel has reviewed the available literature on using COVID-19 convalescent plasma (CCP) to treat COVID-19, particularly in patients who have underlying immunosuppressive conditions or who are receiving immunosuppressive treatments. Based on the available data, the Panel revised the recommendation language for the use of CCP in patients who are immunocompromised. There is currently insufficient evidence for the Panel to recommend either for or against the use of high-titer CCP for the treatment of COVID-19 in hospitalized or nonhospitalized patients who are immunocompromised.
- November 30, 2022 The FDA announced Bebtelovimab is NOT currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data included in the Health Care Provider Fact Sheet.
- November 2, 2022, Transitioning of COVID mAb Therapeutic Reporting from Teletracking to HPOP:
- Recent HHS guidance for hospital data reporting has changed the therapeutic reporting process as reporting is being moved from Teletracking to the Healthcare Provider Ordering Portal (HPOP) system. The implementation date is November 2, 2022 and will consolidate therapeutic reporting for all products and ordering into one system. Reporting for legacy mAb has shifted to once a week on Thursdays by 11:59 pm to coincide with regular therapeutic reporting in HPOP. Data remains important to the federal response and is needed for tracking purposes and strategic decision making to provide more accurate and rapid support to the Regions.
Summary Table of Food and Drug Administration Authorized Treatments for High-Risk Patients
Summary Table of Key Highlights for Preferred Therapeutic Agents
Patients who are underinsured or uninsured can visit the VDH website or call their local health department to locate a nearby Federally Qualified Health Center (FQHC) or Free Clinic for access to COVID-19 treatment.
The Centers for Medicare & Medicaid Services has issued guidance to inform Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s). The guidance may be accessed here.
The Centers for Medicare & Medicaid Services has issued guidance to inform coverage and reimbursement of monoclonal antibodies. Please see the linked flyer and CMS website for reimbursement information below:
VDH: Total Allocations to Therapeutic Administration Sites for February 2023
*Oral Antiviral numbers presented do not include those allocated to Community Pharmacy Enhanced Services Network. These Oral Antiviral courses were bulk ordered and distribution to individual site locations is managed by respective Federal Retail Pharmacy Therapeutic Program (FRPTP) partners, VDH does not have visibility of course distribution to each region.
*Please reference the Outpatient Therapeutic Portfolio- Jurisdiction Allocations for more detail.
- VDH: COVID-19 General FAQs - See Treatment for COVID-19 located under the COVID-19 Basics and Healthcare Providers sections.
- VDH: COVID-19 Therapeutics FAQs for Providers
- COVID-19 Outpatient Therapeutic Treatment Algorithm
- FDA: Paxlovid Prescribing Checklist
- VDH: Paxlovid Prescribing Checklist-Pharmacists
- HHS: Paxlovid Information Sheet
- Liverpool Interaction Checker
- FDA: Molnupiravir Prescribing Checklist
- HHS: Lagevrio Information Sheet
- VDH: Guidance on Expiring & Expired Therapeutics
- VDH: Healthcare & LTC Facility Therapeutics Handout (Español)
- VDH: "Are You at High Risk for COVID-19?" Handout (Español)
- HHS: ASPR Test to Treat Fact Sheet
- CDC: Clinical Care Guidance for Healthcare Professionals about Coronavirus
- CDC: Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19
- COVID-19 Therapeutics Resource Document for UniteUs
- VDH: Treatments Webpage
- CDC: How to Protect Yourself and Others
- CDC: COVID-19 Plan [English] [Spanish]
- VDH: COVID-19 Therapeutics Comparison Chart [English] [Spanish]
- VDH: Paxlovid Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog] [Urdu] [Vietnamese]
- VDH: Lagevrio (Molnupiravir) Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog] [Urdu] [Vietnamese]
- VDH: "Are You at High Risk" Handouts [English] [Spanish] [Arabic] [Chinese] [Korean] [Pashto] [Tagalog] [Urdu] [Vietnamese]
- VDH: "Test Positive" Handouts [English] [Spanish] [Arabic][Chinese] [Korean] [Pashto] [Tagalog] [Urdu] [Vietnamese ]
- CDC: Treatments Your Healthcare Provider Might Recommend if You Are Sick
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