Get the Latest Guidance
COVID-19 cases can result in serious illness, hospitalizations and deaths. New treatments continue to become available to treat or prevent COVID-19. Please use this page to get the latest guidance on COVID-19 Therapeutics in Virginia. Therapeutics administration is a best practice, these medications are available in ample supply and should be prescribed and administered to patients who are eligible.
- On May 24, 2022, the CDC issued a HAN alert related to COVID-19 rebound after Paxlovid treatment. The notice can be reviewed here . COVID-19 rebound, defined as a recurrence of symptoms 2-8 days after initial recovery and/or a positive re-test after testing negative, has been reported. It is also noted that a brief return of symptoms may be a part of the natural course of the virus, independent of Paxlovid treatment and independent of vaccination status. Paxlovid continues to be recommended for early-stage treatment of mild-moderate disease among eligible individuals.
- Recommendations for healthcare providers include:
- There is currently no evidence that additional treatment is needed after rebound
- Isolation precautions in efforts to prevent transmission are recommended after rebound
- Consider clinical evaluation of patients who rebound, particularly if symptoms persist or worsen
- Report rebound to both Pfizer and the FDA
- Recommendations for healthcare providers include:
- On April 13, 2022, U.S. HHS Secretary Xavier Becerra renewed the COVID-19 Public Health Emergency Declaration , effective April 16. The first U.S. public health emergency declaration for COVID-19 was signed in January 2020 as the global pandemic response began and has been renewed every 90 days in adherence to the law.
- On April 4, 2022, FDA revised the emergency use authorization for sotrovimab to reflect that sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients.
- In March 2022, HRSA announced that the HRSA COVID-19 Uninsured Program (UIP) will stop accepting claims for testing and treatment due to a lack of sufficient funds on March 22, 2022.
- In March 2022, FDA revised the emergency use authorization for sotrovimab to limit use of sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant (Regions 1, 2, 5, 9 & 10)
- On February 2022, FDA revised the emergency use authorization for sotrovimab to update the administration timeline to within 7 days of symptom onset. Previously, sotrovimab was recommended for administration within 10 days of symptom onset.
- On February 24, 2022, FDA revised the emergency use authorization for EVUSHELD to change the initial dose for the authorized use. With this EUA revision, FDA has increased the initial authorized dose to 300 mg of tixagevimab and 300 mg of cilgavimab. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose.
- On February 14, 2022, FDA released an emergency use authorization for a new monoclonal antibody, bebtelovimab.
- On January 24, 2022, FDA revised the emergency use authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. FDA noted that Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir are expected to work against the omicron variant and healthcare providers should refer to the NIH COVID-19 Treatment Guidelines to see if these are appropriate for their patients.
Summary Table of Food and Drug Administration Authorized Treatments for High-Risk Patients
Summary Table of Key Highlights for Preferred Therapeutic Agents
Oral AntiviralsThe 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.
Monoclonal AntibodiesThe 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: 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
- VDH: Treatments vs. Vaccine Comparison Handout
- VDH: Dispensing Oral Antivirals in Hospital Emergency Departments
- VDH: Paxlovid Prescribing Checklist
- VDH: Lagevrio (Molnupiravir) Prescribing Checklist
- VDH: Guidance on Expiring & Expired Therapeutics
- VDH: EVUSHELD Fact Sheet for Providers
- This resource is for healthcare providers to understand information about and eligibility requirements for EVUSHELD
- VDH: Healthcare & LTC Facility Therapeutics Handout (Español)
- This resource is intended to be posted and shared in healthcare and LTC facilities to educate patients and/or LTC residents on the benefit of COVID-19 treatment
- VDH: "Are You at High Risk for COVID-19?" Handout (Español)
- This resource is intended to be posted and shared in healthcare facilities (e.g., PCP, pharmacy, urgent care, testing center) for patients to understand if they are eligible for treatment if diagnosed with COVID-19
- VDH: Treatment Option Shareables (Square) (Wide)
- These resources are for healthcare facilities to share through their social media channels
- 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
- Academic Treatment Guidelines
- VDH: Treatments Webpage
- VDH: Treatments Basics Handout
- VDH: Monoclonal Antibody Therapy for COVID-19 Handout
- VDH: EVUSHELD Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog]
- VDH: Paxlovid Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog]
- VDH: Lagevrio (Molnupiravir) Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog]
- CDC: Treatments Your Healthcare Provider Might Recommend if You Are Sick
- Medicare: Coronavirus Disease 2019 (COVID-19) Monoclonal Antibody Treatments
- HHS: Monoclonal Antibodies for High-Risk COVID-19 Positive Patients
- HHS: FAQs About Monoclonal Antibodies For Consumers
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