U.S. NIH Ranks COVID-19 Treatments

The U.S. NIH’s COVID-19 Treatment Guidelines Panel today announced a change to its previous recommendations for COVID-19 treatments.

The purpose of this new NIH statement is to provide clinicians with guidance on the role of bebtelovimab a U.S. FDA Authorized monoclonal antibody treatment, as an additional option for this patient population.

For nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease, the Panel recommends using one of the following therapies, listed in order of preference:

• Nirmatrelvir 300 mg with ritonavir 100 mg (Paxlovid) orally twice daily for five days, initiated as soon as possible and within five days of symptom onset in those aged ≥12 years and weighing ≥40 kg.
• Sotrovimab 500 mg as a single intravenous infusion (IV), administered as soon as possible and within seven days of symptom onset in those aged ≥12 years and weighing ≥40 kg.
• Remdesivir 200 mg IV on Day 1, followed by remdesivir 100 mg IV once daily on Days 2 and 3, initiated as soon as possible and within seven days of symptom onset in those aged ≥12 years and weighing ≥40 kg.
• Bebtelovimab 175 mg as a single IV infusion, administered as soon as possible and within seven days of symptom onset in those aged ≥12 years and weighing ≥40 kg, ONLY if none of the preferred therapies are available, feasible to deliver, or clinically appropriate.
• Molnupiravir 800 mg orally twice daily for five days, initiated as soon as possible and within five days of symptom onset in those aged ≥18 years, ONLY if none of the preferred therapies are available, feasible to deliver, or clinically appropriate.

As noted above, multiple therapeutic agents are currently available and recommended by the Panel to treat nonhospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression, while Omicron is the predominant variant in the U.S. 

The Panel favors ritonavir-boosted nirmatrelvir, sotrovimab, or remdesivir as the preferred therapies for these patients, primarily based on a 79% to 88% reduction in hospitalization or death in treated patients, as well as on the agents’ in vitro activities against the Omicron VOC.

The Panel’s recommendation on bebtelovimab is primarily based on laboratory data showing its potent activity against the Omicron VOC, its BA.1 and BA.2 subvariants, other VOCs, and on limited clinical trial data. 

The assessment of the clinical efficacy of bebtelovimab is limited to 1 small, Phase 2, randomized, placebo-controlled trial in patients at low risk of disease progression and one small randomized controlled trial that compared bebtelovimab to an anti-SARS-CoV-2 mAb combination of bamlanivimab, etesevimab, and bebtelovimab in patients at high risk of disease progression.

More detailed information regarding these therapies can be found in Therapeutic Management of Nonhospitalized Adults With COVID-19.

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