Due the Omicron variant of COVID and the limited supply of COVID therapies, NIH recommends specific therapies for patients at high risk. Federal officials spoke to clinicians on Wednesday.
In order of preference, clinicians should use the oral antiviral nirmatrelvir-ritonavir (Paxlovid), the monoclonal antibody sotrovimab, the IV antiviral remdesivir (Veklury) and finally, the oral antiviral molnupiravir, said Alice Pau, PharmD, of the NIH COVID-19 Treatment Guidelines panel.
While the drugs were ranked from 1 to 4, she noted that nirmatrelvir-ritonavir, sotrovimab, and IV remdesivir three times a day all had similar clinical efficacy, with a relative risk reduction of 88%, 85%, and 87% in hospitalizations and deaths, respectively, versus placebo. However, molnupiravir, with its 30% efficacy, should be used only if the other three choices are not available, Pau noted.
She cited a number of changes to the NIH guidelines regarding COVID therapies made at the end December. These were primarily due to the fact bamlanivimab+ etesevimab, casirivimab+ imdevimab being no longer recommended for outpatients as they have not been shown to be effective against the Omicron variant.
Pau stated that although the clinical efficacy was the main factor in the panel’s recommendations, logistics (e.g., oral vs. IV infusion), time, population, drug interaction potential, and duration also played an important role in their reasoning.
For example, she said that nirmatrelvir-ritonavir, sotrovimab, and remdesivir are all authorized or approved for ages 12 and up, while molnupiravir is authorized only for adults ages 18 and up.
Supply of therapeutics has been a problem, although Colin Shepard, MD, CDC liaison to the Office of the Assistant Secretary for Preparedness and Response, said that this week, the federal government provided 100,000 courses of nirmatrelvir-ritonavir, and 400,000 of molnupiravir.
“Given limited drug supplies, patients at highest risk for severe disease progression should receive the highest priority,” Pau stated.
She reviewed the patient groups where the drugs can be administered, in order of who might receive the most benefit:
- Immunocompromised people who don’t mount a good response to vaccines, unvaccinated