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As more outpatient treatment options become available for COVID-19, a new outpatient treatment overview is available on the COVID-19 Resources site (go to Ambulatory then COVID-19 Patient Care) The information is designed help clinicians determine the best available treatment option for their patients and includes details about oral antivirals, monoclonal antibodies, and more. Read the overview.

See below for the latest updates.

FDA Approves New Outpatient Oral Antivirals 

The FDA has authorized the first oral antivirals for the treatment of mild to moderate COVID-19 infection in outpatients at high-risk of progression to severe disease. Available by prescription only, both treatments should be started as soon as possible after the diagnosis of COVID-19 using either PCR or antigen testing and within five days of symptom onset. Here is an overview of each medication:

• Paxlovid | This drug is a combination of the antiviral nirmatrelvir and the boosting agent ritonavir. It is authorized for treating patients 12 years of age and older and at least 40 kg. There are a number of drug interactions to be aware of and co-administration with certain drugs highly dependent on CYP3A for clearance may be contraindicated. A full drug history should be obtained prior to prescribing, and clinicians with less experience prescribing ritonavir-boosted drugs can refer to this drug-drug interaction guide and consult a pharmacist. Renal adjustment of dosing may be required, and treatment is not recommended in severe liver impairment.
• Lagevrio (molnupiravir) | This antiviral is authorized for use in adults when no alternative COVID-19 specific treatment options that have been authorized or approved by the FDA are available due to lower expected efficacy. Molnupiravir should be avoided in pregnancy due to concerns related to mutagenesis and in children due to possible bone and cartilage toxicity.
• Accessing Supplies | The Virginia Department of Health (VDH) authorizes the distribution of these agents to health systems and pharmacies and monitors for adherence to the Emergency Use Authorization for continued access to the therapy. UVA Pharmacy has requested but not received a supply of these medications from the VDH. Providers can locate other pharmacies in the Commonwealth that may have supplies of these oral antivirals here: COVID-19 Treatment Locator - Monoclonal Antibodies (virginia.gov). Providers are responsible for using these drugs as specified under the terms of their authorization, as detailed in the package inserts. 

Monoclonal Antibodies Update

• Outpatient monoclonal antibodies for COVID-19 treatment I Supplies of COVID-19 Monoclonal Antibodies (mAb) are extremely limited. This shortage includes Sotrovimab, which is the only currently available monoclonal antibody for treatment of COVID-19 infection that may have activity against the dominant circulating omicron variant. Referrals are being prioritized for the highest risk immunocompromised patients until supply catches up with demand. Providers can help patients search the VDH Monoclonal Antibodies Locator for doses at other locations. 

• Evusheld monoclonal antibodies for pre-exposure prophylaxis I The FDA has issued emergency use authorization for tixagevimab-cilgavimab (Evusheld) intramuscular injections for use in pre-exposure prophylaxis in adults and children 12 years and older and at least 40 kg who are moderately to severely immunocompromised and may not mount an adequate immune response to COVID-19 vaccination. Evusheld is not indicated as a treatment for COVID-19 or for post-exposure prophylaxis in those exposed to someone with COVID-19. Evusheld is not a substitute for vaccination. Supply is also very limited, so patients will be prioritized by biomedical risk factors until supply catches up with demand. Referrals are now being accepted for patients within category 1. Learn more about this option and how to refer: UVA Pre-Exposure Prophylaxis for COVID-19 (Evusheld): FAQ​. Providers can help patients search the VDH Monoclonal Antibodies Locator for doses at other locations.