On December 22 and 23, 2021, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) that allow 2 new oral antiviral agents to be used in this patient population: ritonavir-boosted nirmatrelvir (Paxlovid) and molnupiravir.
The NIH’s COVID-19 Treatment Guidelines Panel issued an updated statement today to provide clinicians with guidance on the use of ritonavir-boosted nirmatrelvir (Paxlovid), sotrovimab, remdesivir, and molnupiravir for the treatment of nonhospitalized patients with COVID-19 who are at high risk of progressing to severe disease.
For nonhospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression, the Panel recommends using 1 of the following therapeutics (listed in order of preference):
- Nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) orally twice daily for 5 days, initiated as soon as possible and within 5 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (AIIa).
- Sotrovimab 500 mg as a single IV infusion, administered as soon as possible and within 10 days of symptom onset in those aged ≥12 years and weighing ≥40 kg who live in areas with a high prevalence of the Omicron VOC (AIIa).
- Remdesivir 200 mg IV on Day 1, followed by remdesivir 100 mg IV daily on Days 2 and 3, initiated as soon as possible and within 7 days of symptom onset in those aged ≥12 years and weighing ≥40 kg (BIIa).
- Molnupiravir 800 mg orally twice daily for 5 days, initiated as soon as possible and within 5 days of symptom onset in those aged ≥18 years ONLY when none of the above options can be used (CIIa).
Please share this information with your local care teams as needed. The NIH study team may be able to help too. Contact Thomas Dimaggio at the NIH via email at thomas.dimaggio@nih.gov or Dr. Mihalis Lionakis at lionakism@niaid.nih.gov.