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development infrastructure on a “just in case” basis is prohibitively expensive and impractical. Pivoting existing frameworks addressing endemic disease between pandemics is a more practical approach. Although the global response to COVID-19 has been highly variable, there are important examples of success that we must use to shape our response for the future. To provide the readiness the world needs and deserves, we must learn from the past but think differently in the future. • Two COVID-19 oral antiviral therapies have received Emergency Use Authorization from the U.S. Food and drug Administration (FDA), Paxlovid (Pfizer) and molnupiravir (Merck). o Paxlovid and molnupiravir reduce the risk of hospitalization and death by 88% and 30% respectively, in patients at high-risk for severe COVID-19 disease when started early after symptom onset. o Prescriptions in New York City (NYC) will be filled by Alto Pharmacy to provide free, same day home delivery regardless of insurance or immigration status. o Paxlovid is the preferred product and is available for patients age 12 years and older. o Molnupiravir should be considered for patients age 18 years and older for whom alternative FDA- authorized COVID-19 treatment options are not accessible or clinically appropriate. • At this time, Sotrovimab (Xevudy) is the only authorized monoclonal antibody product expected to be effective against the omicron variant of SARS-CoV-2. o There is a pause on allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV until further notice. These products do not retain activity against omicron and should not be used. • Adhere to New York State Department of Health (NYS DOH) guidance on prioritization of high-risk patients for anti-SARS-CoV-2 therapies during this time of severe resource limitations. • While therapeutic shortages continue, off-label use of remdesivir on an outpatient basis may be an option. • Check nyc.gov/health/covidprovidertreatments regularly for updates. December 27, 2021 Dear Colleagues, This HAN includes information about available COVID-19 outpatient therapeutics, including newly authorized oral antiviral treatment. While the availability of oral antivirals for treatment of COVID-19 is an important milestone, it comes at a time of a significant surge in cases and reduced effectiveness of existing NEW YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE Dave A. Chokshi, MD, MSc Commissioner therapeutics due to the omicron variant, which is now the predominant variant nationally and estimated by the Centers of Disease Control and Prevention (CDC) to account for over 90% of cases in New York. Supplies of oral antivirals will initially be extremely limited, and there is now only one monoclonal antibody product that is effective for treatment of infection caused by the omicron variant. While supplies remain low, adhere to the NYS DOH guidance on prioritization of anti-SARS-CoV-2 therapies for treatment and prevention of severe COVID-19 and prioritize therapies for people of any eligible age with moderate to severe immunocompromise regardless of vaccination status or who are age 65 and older and not fully vaccinated with at least one risk factor for severe illness. COVID-19 Oral Antiviral Treatment The FDA authorized the first oral antiviral therapies, Paxlovid from Pfizer and molnupiravir from Merck, to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, regardless of vaccination status. The oral antivirals work by interfering with several steps in the reproductive process of SARS-CoV-2 to prevent efficient replication of the virus in host cells. The U.S. Department of Health and Human Services (HHS) provides oral antivirals at no cost to patients. Paxlovid is the preferred product, and molnupiravir can be considered for patients age 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate. Limited supply will require providers to prioritize treatment for patients at highest risk for severe COVID-19 until more product becomes available. Paxlovid clinical trials among 2,246 high-risk patients showed an 88% reduction in the risk for hospitalization and death among people taking Paxlovid compared to those taking placebo. Paxlovid is a combination treatment with PF-07321332 (or nirmatrelvir) and ritonavir. PF07321332 inhibits the main protease of SARS-CoV-2 virus, the 3CL-like protease, that impedes synthesis of other non-structural proteins and ultimately inhibits viral replication. Ritonavir is a protease inhibitor (also used in HIV treatment) that acts as a pharmacokinetic enhancer of protease inhibitors. Molnupiravir clinical trials among 1,433 high-risk patients showed a 30% reduction in the risk for hospitalization and death among people taking molnupiravir compared to those taking placebo. Molnupiravir is the pro-drug of a nucleoside analog that competes with the viral RNA polymerase and induces RNA mutations that ultimately have an antiviral effect. Eligibility Oral antiviral treatment is authorized for patients who meet all the following criteria: • Age 12 years and older for Paxlovid, or 18 years and older for Molnupiravir • Weigh at least 40 kg (88 pounds)
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