COVID-19 Therapeutics

Important Updates

On May 24, 2022, the CDC issued a HAN alert related to COVID-19 rebound after Paxlovid treatment. The notice can be reviewed here . COVID-19 rebound, defined as a recurrence of symptoms 2-8 days after initial recovery and/or a positive re-test after testing negative, has been reported. It is also noted that a brief return of symptoms may be a part of the natural course of the virus, independent of Paxlovid treatment and independent of vaccination status. Paxlovid continues to be recommended for early-stage treatment of mild-moderate disease among eligible individuals.
- Recommendations for healthcare providers include:
  - There is currently no evidence that additional treatment is needed after rebound
  - Isolation precautions in efforts to prevent transmission are recommended after rebound
  - Consider clinical evaluation of patients who rebound, particularly if symptoms persist or worsen
  - Report rebound to both Pfizer and the FDA
On April 13, 2022, U.S. HHS Secretary Xavier Becerra renewed the COVID-19 Public Health Emergency Declaration , effective April 16. The first U.S. public health emergency declaration for COVID-19 was signed in January 2020 as the global pandemic response began and has been renewed every 90 days in adherence to the law.
On April 4, 2022, FDA revised the emergency use authorization for sotrovimab to reflect that sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients.
In March 2022, HRSA announced that the HRSA COVID-19 Uninsured Program (UIP) will stop accepting claims for testing and treatment due to a lack of sufficient funds on March 22, 2022.
In March 2022, FDA revised the emergency use authorization for sotrovimab to limit use of sotrovimab to treat COVID-19 in some U.S. regions due to the BA.2 Omicron sub-variant (Regions 1, 2, 5, 9 & 10)
On February 2022, FDA revised the emergency use authorization for sotrovimab to update the administration timeline to within 7 days of symptom onset. Previously, sotrovimab was recommended for administration within 10 days of symptom onset.
On February 24, 2022, FDA revised the emergency use authorization for EVUSHELD to change the initial dose for the authorized use. With this EUA revision, FDA has increased the initial authorized dose to 300 mg of tixagevimab and 300 mg of cilgavimab. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose.
On February 14, 2022, FDA released an emergency use authorization for a new monoclonal antibody, bebtelovimab.
On January 24, 2022, FDA revised the emergency use authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. FDA noted that Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir are expected to work against the omicron variant and healthcare providers should refer to the NIH COVID-19 Treatment Guidelines to see if these are appropriate for their patients.

Summary of COVID-19 Therapeutics


	Medication	How is it given?	When should I take it?	Where can I find it?
Prevention before exposure	EVUSHELD (Monoclonal antibodies [Español])	By injection	Once, when not currently infected with COVID-19	COVID-19 Treatment Locator
Prevention after exposure (Treatments for mild to moderate illness)	Bebtelovimab (Monoclonal antibodies [Español])	By injection, or infusion into a vein	Within 7 to 10 days of symptoms starting, depending on the monoclonal antibody	COVID-19 Treatment Locator
Treatments for mild to moderate illness	Molnupiravir, Paxlovid (Oral antivirals [Español])	By oral tablet	Within 5 days of symptoms starting	COVID-19 Treatment Locator


Preference of Therapeutics	Therapeutic Agent	Key Highlights
First line	Paxlovid Remdesivir	• Paxlovid has many drug-drug interactions; not all COVID-19 positive patients can safely take this medication • Remdesivir is cost prohibitive • Remdesivir must be administered via an IV infusion over 3 days, which may be burdensome • Remdesivir supply is not controlled by the state; providers may purchase via the private sector
Second line	Bebtelovimab Molnupiravir (Lagevrio)	• Risk reduction of hospitalizations is low • Molnupiravir is not safe for pediatric patients and a black box warning exists for patients who are pregnant • Should only be used when Paxlovid or Remdesivir are not available or are contraindicated

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