Bethesda, MD—New Coronavirus Disease 2019 (COVID-19) Treatment Guidelines from the National Institutes of Health advise pharmacists and other healthcare professionals that the spread of the Omicron BA.2 subvariant is a factor in determining which therapies to use and—although sotrovimab remains active against the Omicron BA.1 and BA.1.1 subvariants—should not be used in areas where that subvariant is dominant.

That subvariant has quickly become dominant in the United States, representing more than 70% of the cases tested, according to the CDC.

Previously, the panel recommended sotrovimab, an anti-SARS-CoV-2 monoclonal antibody (mAb), as a preferred therapy for the treatment of nonhospitalized patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease. Now, the National Institutes of Health advises that, although sotrovimab remains active against the Omicron BA.1 and BA.1.1 subvariants, it has substantially decreased in vitro activity against the BA.2 subvariant.

In fact, the FDA recently updated the Emergency Use Authorization for sotrovimab to note that it is not authorized for use in geographic regions where infection is likely to have been caused by nonsusceptible SARS-CoV-2 variants. Distribution of sotrovimab had been paused in these regions.

"As a result of these recent changes and the increasing prevalence of the BA.2 subvariant across all regions, the panel no longer recommends sotrovimab as a preferred therapy for nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease," according to the guidelines.

The revisions list the following as preferred, in order of preference:

• Paxlovid (ritonavir-boosted nirmatrelvir) (AIIa)
• Remdesivir (BIIa)

Alternative therapies are recommended only when neither of the preferred therapies is available, feasible to use, or clinically appropriate. Listed in alphabetical order, those are:

• Bebtelovimab (CIII)
• Molnupiravir (CIIa)

The guidance goes on to say that sotrovimab (CIII) can be used only in regions where the Omicron BA.2 subvariant is not the dominant subvariant and if none of the preferred or alternative options are available, feasible to use, or clinically appropriate.

The panel also cautioned about limited or no data on dose modifications for patients with organ failure or those who require extracorporeal devices. Pharmacists and other healthcare providers are urged to refer to product labels, when available.

It also noted that, currently, not enough data exist to determine whether certain medications can be safely coadministered with therapies for the treatment or prevention of COVID-19. The panel says that, when concomitant medications with similar toxicity profiles are used, clinicians should consider performing additional safety monitoring.

"The potential additive, antagonistic, or synergistic effects and the safety of using combination therapies for the treatment or prevention of COVID-19 are unknown. Clinicians are encouraged to report AEs [adverse events] to the FDA Medwatch program," according to the guidelines update.

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