The Centers for Disease Control and Prevention (CDC) has issued a Health Alert Network (HAN) Health Advisory that provides rationing guidelines for treating patients with COVID-19 when effective treatments are in short supply.
The problem is that two monoclonal antibody treatments for COVID-19 are not effective against the Omicron variant, with its numerous mutations in the spike protein, the CDC said. These treatments are bamlanivimab combined with etesevima and casirivimab combined with imdevima.
However, a third monoclonal antibody, sotrovimab, is effective against Omicron, but the national supply of the medication is limitedthe agency said.
As a result, the CDC says the use of said sotrovimab, which is by GlaxoSmithKline, should be prioritized for non-hospitalized patients with risk factors for progression to severe COVID-19. These groups of patients include:
- People who are unvaccinated or have not received all vaccines and booster shots
- People with clinical risk factors, including people who are 65 years of age or older or are immunocompromised.
The CDC said it recommends the use of sotrovimab when Paxlovid, which is marketed by Pfizer, is not indicated due to potential severe drug-drug interactions or if Paxlovid is not available. Another shortcoming of Paxlovid is that treatment must be started within five days of symptom onset.
Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. The drug cocktail is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets.
A second oral antiviral, molnupiravir, also has received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). However, clinical trials found the drug to be less effective, the CDC said. Molnupiravir reduced severe outcomes (hospitalization and death) by 30%, compared with 88% for Paxlovid, the CDC said.
Molnupiravir was developed by Merck and Ridgeback Biotherapeutics, and it is authorized for the treatment for mild to moderate COVID-19 in adults 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, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.
